ASPEL S.A.

PL 32-080 Zabierzów, os. H. Sienkiewicza 33

tel. +48 12 285 22 22, fax +48 12 285 30 30
www.aspel.com.pl

OPERATION MANUAL

Pressure recorder
ASPEL 308 ABPM
v.xx.xyz

Zabierzów, 08.05.2020, Edition III

Operation manual ASPEL 308 ABPM IU-AT-137_III

We are pleased you have chosen ASPEL 308 ABPM pressure

recorder, which was created as a result of years of research and
experience gained in direct contact with the customer. You have
chosen quality, durability and high efficiency - the characteristics of
the ASPEL 308 ABPM pressure recorder.

ASPEL company also offers spirometers, exercise test kits, ECG

devices and their equipment such as apparatus trolleys, apparatus
bags, ECG cable, as well as electrodes and ECG paper and a wide
range of medical equipment accessories for Holter recorders. For
details visit our website: www.aspel.com.pl.

Read this manual carefully as it contains tips for safe installation,

use and maintenance as well as some practical tips to optimize the
use of the device.

Keep this Operation Manual for later referance.

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Table of contents
1. SAFETY INFORMATION .................................................................................................................4
1.1. MANUFACTURER GUIDELINES ON SAFETY OF USE .............................................................................4
1.2. INDICATIONS FOR PERFORMING ABPM ............................................................................................7
1.3. CONTRAINDICATIONS TO ABPM ......................................................................................................7
1.4. WORKING, TRANSPORT AND STORAGE CONDITIONS..........................................................................8
1.5. MEANINGS OF SYMBOLS .................................................................................................................8
2. RECORDER DESCRIPTION ..........................................................................................................10
2.1. PURPOSE ....................................................................................................................................10
2.2. GENERAL DESCRIPTION ................................................................................................................10
2.3. DESIGN .......................................................................................................................................11
2.4. KEYBOARD ..................................................................................................................................11
2.5. MAIN SCREEN ..............................................................................................................................12
2.6. RECORDER MENU ........................................................................................................................13
2.7. BASIC TECHNICAL AND OPERATING PARAMETERS ...........................................................................14
2.8. FUNCTIONAL FEATURES ................................................................................................................15
2.9. ACCESSORIES..............................................................................................................................16
2.10. MANUFACTURER AND LABEL .........................................................................................................16
3. EXAMINATION ...............................................................................................................................17
3.1. RECORDER PREPARATION ............................................................................................................17
3.1.1. Automatic programming by software ................................................................................17
3.1.2. Quick manual start ............................................................................................................18
3.1.3. Advanced manual programming .......................................................................................18
3.2. BATTERY REPLACEMENT...............................................................................................................20
3.3. PATIENT PREPARATION .................................................................................................................21
3.4. START OF MEASUREMENTS RECORDING ........................................................................................22
3.5. EVENT BUTTON ............................................................................................................................22
3.6. COMPLETION OF MEASUREMENTS RECORDING ...............................................................................23
3.6.1. Locked device (automatically programmed) .....................................................................23
3.6.2. Non-locked device (manually programmed) .....................................................................23
3.7. MEASUREMENT READING ..............................................................................................................24
4. ADVANCED FEATURES ...............................................................................................................25
4.1. DATE AND TIME SETTINGS .............................................................................................................25
4.2. BATTERY TYPE CHOISE .................................................................................................................25
4.3. PEDIATRIC SETTINGS MODE ..........................................................................................................26
4.4. MANOMETER TEST .......................................................................................................................26
4.5. MANUFACTURER’S SETTINGS ........................................................................................................27
4.6. AIRTIGHTNESS TEST .....................................................................................................................28
4.7. DEVICE UNLOCKING......................................................................................................................29
5. MAINTENANCE AND TECHNICAL SUPPORT ............................................................................31
5.1. CLEANING, DISINFECTION, MAINTENANCE, SERVICING .....................................................................31
5.2. ENVIROMENTAL PROTECTION ........................................................................................................31
5.3. CUSTOMER SERVICE ....................................................................................................................31
5.4. TROUBLESHOOTING .....................................................................................................................32
6. ATTACHMENT A - ELECTROMAGNETIC COMPATIBILITY DECLARATION ...........................34

7. ATTACHMENT B – COOPERATION OF THE ASPEL 308 ABPM RECORDER WITH A

PC ...................................................................................................................................................36
7.1. INTRODUCTION.............................................................................................................................36
7.2. GENERAL REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS.......................................................36

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1. Safety information
1.1. Manufacturer guidelines on safety of use

Instructions of use
• Improper usage of the device may be the cause of an accident.
• It is recommended that the operating manual is kept with the device, so
that it is used as a reference during usage and troubleshooting of 308
ABPM pressure recorder.
• The Operation Manual will help the user to operate and maintain 308
ABPM pressure recorder correctly.
• Observing the instructions in this manual will make it possible for the
device to function smoothly and reliably, fulfill the goals set by users for
308 ABPM pressure recorder, as well as will secure safety of usage.

Staff
• Pressure recorder should be used under the supervision of a qualified
and trained medical personel.
• Staff should make sure (for example, by observing a given limb) that the
recorder's operation does not cause prolonged impairment of the patient's
blood circulation.

Patient
• Prolonged cuff pressure caused by entanglement and/or collapse of the
pressure tubing interferes with blood flow and can cause harmful injury to
the patient.
• The medical personnel performing the examination are absolutely
responsible for the qualification of the Patient to perform the examination
using a long-term non-invasive blood pressure recorder.
• The medical personnel performing the examination should, through the
observation of the limb and a preceding medical interview with the
patient, be absolutely certain that putting on the cuff, or in particular the
cuff with the metal clasp, will not cause the patient any impairment of
blood circulation and, consequently, a threat to health and life.

ASPEL 308 ABPM Recorder

• The recorder is an internally powered medical device with CF type
application part and ABS housing. The patient is not exposed to electric
shock from the recorder in any way.
• The results of blood pressure measurements provided by the recorder are
only a reference point. The final diagnosis is up to the doctor.
• Any blood pressure measurement can be influenced by the place of
measurement, the patient's position (standing, sitting, lying), physical
effort or physiological condition of the patient.

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• Note that factors such as frequent arrhythmias, premature beating or

atrial or ventricular fibrillation, arterial sclerosis, poor perfusion, diabetes
mellitus, age, pregnancy, pre-eclampsia, kidney disease, patient
movements, tremors, chills may affect the recorder and/or blood pressure
reading.
• In case of loss of essential performance or basic safety of the recorder,
the device should be taken out of use until it is repaired.
• The time of proper operation of the recorder depends mainly on the
efficiency of its components, which in normal conditions should remain
efficient for 10 years. If this time is exceeded, there is an increased
probability of damage resulting from aging of elements, which may lead to
failure of the device.
• All repairs should be carried out in authorized service points of ASPEL
S.A.
• Any modifications of the device is not allowed.

Operating environment
• It is not allowed to use the device in humid places, directly sunny and
exposed to precipitation, in the presence of dust, close to flammable or
explosive materials, in the atmosphere contaminated with corrosive
components.
• The recorder is not designed for use in rooms with flammable gases or
vapours and is not suitable for use in oxygen-rich environments.
• In order to obtain correct results, the patient should be informed to avoid
being in close proximity to high-power electrical equipment or other
sources of electromagnetic interference such as an electric blanket, an
electric pillow, etc.
• Where appropriate, the operation of the recorder may be affected by
extreme values of temperature, humidity and altitude.
• Portable RF communication equipment, e.g. mobile phones (including
peripheral devices such as antenna cables and external antennas) should
be used not closer than 30 cm (12 inches) to any part of the recorder,
including cables specified by the manufacturer. Otherwise, the operation
of the device may be degraded.
• Avoid using the recorder near or stacked with other devices, as it may
cause improper operation.
• Do not place the recorder, including accessories, directly near heat
sources such as: ovens, heaters etc..

Batteries
• Use alkaline batteries, Ni-MH, Li-Ion or Li-Fe batteries in the recorder.
• Improper operation of the recorder may lead to overheating, ignition,
explosion, or reduction of battery capacity. Therefore, it is necessary to
read the Operation Manual carefully and pay attention to the warning
messages.
• Leaving batteries in unused recorder or using faulty, defective batteries
may damage the recorder and void the warranty.
• Do not heat the battery or throw it into fire or water.

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• Stop using the battery immediately when it leaks or smells badly. If skin or
clothing has been in contact with the battery electrolyte, clean it with
clean water. If the battery electrolyte has leaked into your eyes, do not
wipe them, but rinse them with plenty of clean water and visit a doctor
immediately.

Accessories
• Only accessories supplied by the manufacturer should be used with the
recorder.
• Use of accessories and cables other than those specified or supplied by
the manufacturer may increase electromagnetic emissions or reduce the
electromagnetic immunity of the recorder and cause malfunction.
• Select the cuff according to the size of the arm. Using the wrong cuff size
may result in incorrect, false blood pressure measurements.

Operation
• Improper use of the recorder may cause an accident.
• The recorder is not designed to work with high frequency surgical
devices.
• Avoid squeezing or restricting the pressure cable.
• Protect the recorder from being flooded or wetted.
• Only connect devices that do not exceed very low safety voltage (25 V for
AC or 60 V for DC) to the USB connector.
• The wired connection of the recorder to other devices may cause a
previously unidentified risk to patients, operators or third parties, which
must always be identified, analysed, evaluated and controlled prior to
such connection. Additionally, any changes to the USB interface may
introduce new risks and require additional analysis.
• During the simultaneous operation of the recorder with a PC and the
measurement, it is required that the system constructed in such a way
meets the insulation and leakage currents requirements for medical
electrical systems (EN 60601-1) and that the PC devices are outside the
patient's environment (min. 1.5 m free space around the patient).
• The efficiency of accessories and the recorder itself should be
periodically checked. It is necessary to contact an authorized service
point every time when irregularities in the recorder's functioning are
noticed.
• To prevent possible damage of the keyboard, do not use sharp or hard
objects to press the keys. Operate the keyboard with your fingers only.
• Special precautions should be taken during defibrillation. Operators must
not touch the patient undergoing defibrillation or the devices to which the
patient is connected.

Environmental protection
• There is a potential risk of environmental pollution associated with the
disposal of equipment, accessories and cables at the end of their service
life. The equipment and its accessories should be disposed of in
accordance with applicable laws.
• Disposal of used batteries and accumulators should comply with the
applicable law.

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General
• Failure to comply with the above rules may result in a safety hazard, for
which the manufacturer is not responsible.
• The manufacturer is not responsible for injuries to persons or damage to
the recorder's components or other objects caused by:
− not reading and not observing these manual,
− improper power supply,
− improper use,
− inadequate maintenance,
− repairs carried out by an unauthorized service,
− use of non-original or non-recommended parts and
accessories,
− operation under inappropriate conditions.

1.2. Indications for performing ABPM

Automatic blood pressure measurement (ABPM) is usually performed over
a 24-hour period with programmed measurement intervals every 15 ÷ 30
minutes during activity and 30 ÷ 60 minutes during sleep.

1. Confirmation of the diagnosis of hypertension in patients with grade 1

hypertension in office measurements and low/moderate cardiovascular risk.
2. Suspected hypertension of the white lab coat.
3. Suspected masked hypertension.
4. Suspicion of hypotonia (dizziness, falls, fainting, loss of consciousness) or
dysfunction of the autonomic system.
5. Detection of true or suspected resistant hypertension - suspected white coat
effect in patients with treated hypertension.
6. Hypertension in pregnant women.
7. Hypertension in patients with glaucoma.
8. Assessment of blood pressure at night and its decrease in patients with
OBS, diabetes, PChN and after vascularized organs transplantation.

1.3. Contraindications to ABPM

The medical personnel performing the examination are absolutely responsible
for the qualification of the Patient to perform the examination using a long-term
non-invasive blood pressure recorder.

1. The use of the cuff over the wound may cause further injuries to the patient.
2. If endovascular access, therapy or an arterio-venous fistula (A-V) are
present, applying pressure to any limb through the cuff (temporary
interference with blood flow) may cause injury to the patient.
3. Consideration should be given to the use of the cuff and its pressure on the
shoulder on the mastectomy side or the removed lymph nodes.

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4. An increase in cuff pressure may temporarily cause the loss of the function
of a simultaneously used monitoring device on the same limb.
5. Do not use in patients with abnormal, irregular heart rhythm, including
patients with arrhythmias.
6. Do not use in patients with neck artery or aortic valve stenosis.
7. Do not use in neonates, paediatric patients under 3 years of age or patients
with a known tendency to form bruises.

1.4. Working, transport and storage conditions

ASPEL 308 ABPM is designed to work under the following conditions:
o ambient temperature +5°C ÷ +40°C,
o relative humidity 15% ÷ 95% (non-condensing),
o atmospheric pressure 70 kPa ÷ 106 kPa.

ASPEL 308 ABPM should be stored and transported under the following conditions:
o ambient temperature -20 °C ÷ + 60 °C,
o relative humidity 10% ÷ 95% (non-condensing),
o atmospheric pressure 70 kPa ÷ 106 kPa.

The air should not be heavily contaminated with corrosive components.

If the recorder has been stored or transported in a temperature exceeding the
range of working conditions, after taking the device out of packaging, it is
necessary to wait proper time until the recorder adapts to the climatic conditions
prevailing in the room where it will be used.

1.5. Meanings of symbols

Comments and warnings relating to safe use and essential

functioning.

Important instructions and comments from the manufacturer.

General warning sign.

Follow the Operation Manual.

Date of manufacture.

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Address of the manufacturer.

CF application part.

The transport packaging should be protected from moisture.

Indicates the correct vertical position of the transport packaging.

The content of the transport packaging is fragile and should therefore

be handled carefully.

Indicates the maximum number of identical packages that can be

stacked on top of each other.

Indicates temperature ranges in which the transport packaging

should be stored and moved.

Prohibition to dispose of waste equipment together with other waste.

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2. Recorder description
2.1. Purpose
The ASPEL 308 ABPM pressure recorder is a long-lasting recorder of non-invasive
blood pressure measurements for use in clinics, hospitals, outpatient centres and
specialist surgeries.

The recorder enables to perform oscillometric blood pressure assessment in adult

patients and paediatric patients (from 3 years of age). Arterial blood pressure is
assessed by using a blown cuff, accurate pressure transducer and deflation valve.

2.2. General description

The recorder is powered by four LR6 (AA) alkaline batteries or rechargeable batteries
(AA), which enables weekly work or at least 500 measurements. The low weight and
small size make the recorder a highly ergonomic device.

The recorder is made in modern microprocessor technology using 24-bit analogue-

digital processing and an independent, autonomous safety system with a separate
additional measuring track. Colour, graphic OLED display enables presentation of
current pressure in numerical and graphic form, presentation of all recorded
measurement results and statistical data.

Recording parameters are set via USB interface from ASPEL 508 ABPM software
installed on a PC or from the recorder's menu.

The tests are remembered in the internal non-volatile EEPROM memory until the
user removes them (e.g. by reprogramming the recorder).

The Event button allows you to record pressure on patient’s request.

ASPEL S.A. offers training in operating the ASPEL 308 ABPM recorder.

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2.3. Design
1

2
3

Fig. 2.3.1. ASPEL 308 ABPM Recorder

1. Cuff wire socket.

2. OLED colour graphic display.
3. Event button.
4. Keyboard.
5. USB socket.

2.4. Keyboard
The recorder is equipped with a keyboard with function keys for easy operation.

Fig. 2.4.1. Keyboard

Exit the menu, go back to the level above, cancel.

Moving around the menu, scrolling up the displayed items and increasing the
edited value.

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Moving around the menu, scrolling down the displayed items and decreasing
the edited value.

Entering the menu, going to the level below, accepting changes.

The use of sharp objects to operate the keyboard may damage the keyboard. It is
recommended to operate the keyboard with fingers only.

2.5. Main screen

Fig. 2.5.1. Graphical interface screen

1. Status bar - always visible element of the graphical interface screen,

displaying information icons, date, time, battery status, USB connection.
System operating status, respectively: everything is working
well, attention or verification of operation and serious error.

Pediatric mode of the recorder.

There are stored tests in the device memory. Red colour - full
memory.
Recording mode started according to the programmed
schedule (Holter method).

Pressure measurement, respectively: pumping and deflation.

Active connection via USB, power supply via USB.

Battery status.

2. Main screen - displays the main elements depending on the current

recorder operation status.

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2.6. Recorder Menu

Screen 1/4 Screen 2/4 Screen 3/4 Screen 4/4

Name of the device Measuring periods 1, 2 ,3 Measuring periods 4, 5 ,6 Service information

Among others, the version
ID – patient number (PESEL) 1 - 08:00 - 22:00 A 20 4-… number
@ - date of first test 2 - 22:01 - 07:59 D 45 5-… software and hardware
# - memory usagei (n, %) 3-… 6-… version of the device.
$ - global workflow
Information

Starting registration
Start Holter recording mode
according to the pre-
programmed schedule.

Quick start

Recorded test 1 Recorded test 2 Recorded test N

T – testing time
HR - heartbeat T – testing time T – testing time
SYS - systolic pressure
DIA - diastolic pressure
HR - heartbeat
SYS - systolic pressure
… HR - heartbeat
SYS - systolic pressure
DIA - diastolic pressure DIA - diastolic pressure
Tests

Service

Manometer test Airtightness test

Measurement of static Pneumatic system

pressure within at least the airtightness measurement
nominal blood pressure range. together with cuff tightness
Manometer Airtightness test
measurement.

Manufacturer settings

Resetting to manufacturer
optimal settings.
Manufacturer
settings

Settings Settings Settings Settings

(patient number, time, date, (mode, sound, blocking) (measurement periods) (blocking and starting
battery type) recording)
M - (A, P) 1 - 08:00 - 22:00 A 20
ID – patient number (PESEL) S - (ON, OFF) 2 - 22:01 - 07:59 D 45 L - (ON, OFF)
Programming T - time / date +++ H: START
B - (BATT, AKU)

Fig. 2.6.1. Menu tree

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2.7. Basic technical and operating parameters

Physical parameters
Dimensions: (90 x 36 x 93) mm (len. x wd. x ht.)
Weight: < 190 g (without battery)
Case: moulded ABS plastic
Electrical parameters
Power supply: four alkaline batteries LR6 (AA) or rechargeable
batteries (AA);
USB port: 5 VDC
Current consumption: For batteries and for USB:
< 400 mA – measurement
< 70 mA – readiness to work
Pressure measurement
Measuring range: Adult mode: (0 ÷ 300) mmHg ( relative to
atmospheric pressure)
Pediatric mode: (0 ÷ 150) mmHg ( relative to
atmospheric pressure)
Pressure sensor: High-quality, high accuracy and reliability with
compensating circuit
Overall accuracy: 1,25%
Temperature influence compensation: (0 ÷ 50)ºC
Analogue-digital processing: 24 bits, sampling 1000 sps
Deflation: linear, adaptive
Performance parameters
Estimated working time: About 1 week (measurements every 30 minutes)
Number of tests in memory: 1000
Number of measurement periods: 6
Definition of activity/sleep yes
Stored data: name, surname, ID, device name
Deflation: automatic and adjustable (1000 ÷ 5000) µmHg/s,
adjustable resolution 1 µmHg/s
Mode of operation: pediatric / adult
Pressure setting: initial and maximum pressure
Stationary work: USB-only operation, control via USB and manual
operation
Additional requirements
Type of protection against electric internally powered, Class II device
paralysis (EN 60601-1):
Application part (EN 60601-1): CF type

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Class of medical device: IIa (rule 10)

IP protection class: IP X0
Clinical measurement accuracy: EN ISO 81060-2 *
Safety of use: EN 60601-1, EN 60601-2-30
Electromagnetic compatibility: EN 60601-1-2
* excluding pregnant patients (also pre-eclampsia)

2.8. Functional features

1. Cooperation with ASPEL 508 ABPM software and automatic configuration
of the recorder.
2. Possibility of manual programming without using a computer and dedicated
programming.
3. Possibility of quick start of registration without using a computer and
dedicated programming.
4. Built-in default, recommended schedule for recording Holter measurements
divided into activity and sleep mode.
5. Operation up to a week of time, memory for 1000 measurements.
6. Internal real time clock.
7. Useful keyboard and a separate event button for asynchronous
measurements (e.g. when you feel unwell).
8. Clear, graphic OLED colour display (262144 colours).
9. Two functionalities:
o battery operation - full functionality,
o online operation - power supply only from USB, no batteries - full
measurement functionality with the possibility of transferring current
measurement data online, stationary pressure recorder mode,

10. Full presentation of measurement data from the current test:

o current cuff pressure (numerical value, graphical value - bargraph),
o measurement results (systolic, diastolic, mean and HR),
o all possible errors in the form of warnings and codes.

11. Detailed menu:

o informational data (e.g. device name, patient ID, date and time of start of
tests, number of stored tests and availability of free memory, total process,
additional service data),
o quick start - quick start registration with current settings,
o all recorded measurement results (order number, time of measurement,
systolic, diastolic, average and HR),
o resetting to manufacturer settings,
o configuration and programming of the recorder for automatic operation.

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12. Manometer test function (static pressure measurement from two

independent measuring modules).
13. Air-tightness test function (automatic verification of correct operation, valves
tightness, sensors, pump and cuff tightness).
14. Energy saving in multi-hour recording mode (use of deep sleep).

2.9. Accessories
1. Adult cuff - medium size, arm circumference (25 ÷ 35) cm
2. Pressure cable
3. Cuff and pressure cable connector
4. Bag for the recorder with a belt
5. Alkaline batteries LR6 (AA) - 4 pcs.
6. Operation manual
7. Warranty card

Optional accessories:

1. Pediatric cuff - small size, arm circumference (18 ÷ 26) cm

2. Adult cuff - large size, arm circumference (33 ÷ 47) cm

All accessories are always available from ASPEL S.A. www.aspel.com.pl.

2.10. Manufacturer and label

ASPEL S.A.
os. H. Sienkiewicza 33
PL 32-080 Zabierzów
tel. +48 12 285 22 22, fax +48 12 285 30 30
[email protected]
www.aspel.com.pl

Fig. 2.10.1. Label - nameplate

SN –device serial number.

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3. Examination
3.1. Recorder preparation
Preparation of the recorder to perform blood pressure measurements in a specific
cycle (Holter recording mode) is done through the ASPEL 508 ABPM software or
from the recorder menu.

Starting the Holter recording mode via software or from the recorder menu
deletes all previously performed tests and patient data.

3.1.1. Automatic programming by software

Before you start working with ASPEL 508 ABPM software, please read the
operation manual of this software.

The recorder should be connected to a PC / laptop with the licensed ASPEL 508
ABPM software installed using a USB cable. The software additionally enables
programming a number of recording parameters (including maximum cuff pressure or
pediatric mode).

Communication with ASPEL 508 ABPM software can be done without using
batteries. The device is powered via USB port.

The recorder programmed through the software is always locked to prevent the
change of settings during automatic blood pressure measurement and/or loss of
measurement data.

Fig. 3.1.1.1. Programmed and locked

The ASPEL 508 ABPM software automatically updates the date and time in the
recorder and allows the display of measurement results to be activated.

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3.1.2. Quick manual start

In the menu of the recorder, go to the quick start - Holter recording mode and confirm
the action.

Fig. 3.1.2.1. Quick start menu

Fig. 3.1.2.2. Waiting for confirmation of registration start

Quick start allows you to start Holter recording mode according to a pre-
programmed schedule.

The recorder programmed by quick start is always locked and the display of blood
pressure measurement results is disabled.

In case of unprogrammed measurement schedule, quick start starts the default

schedule, recommended: activity from 6.00 to 23.00, measurement every 30
minutes, sleep from 23.00 to 6.00, measurement every 60 minutes.

3.1.3. Advanced manual programming

In the menu of the recorder, go to programming and follow the order.

Fig. 3.1.3.1. Programming menu

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Screen
1/4

1. Setting the patient number (ID, PESEL, other number)

2. Setting the time and date (if necessary)
3. Setting the type of batteries used (if necessary)

BAT - alkaline batteries,

AKU - batteries (e.g. Ni-MH or Li-Ion).

Screen
2/4

1. Setting the recorder operation mode

A - work mode for adult patients, pregnant women, including

preeclampsia patients,
P - work mode for pediatric patients from the age of 3.

2. Setting of the sound signal before measurement

ON - sound on,
OFF - sound off.

Screen
3/4

1. Adding measurement periods

The measurement period is defined by start time, end time, patient

activity (A - activity, S - sleep) and frequency of measurements (in
minutes). A maximum of 6 measurement periods can be added.
Adding by the "+++" symbol. Only the last measurement period can
cross midnight.

2. Deleting measurement periods

The measurement period is deleted by setting the measurement

frequency to zero and accepting the removal. Deleting the only
measurement period is not possible - the default recommended
schedule is restored (two measurement periods): activity from 6.00 to
23.00, measurement every 30 minutes, sleep from 23.00 to 6.00
measurement every 60 minutes.

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Screen
4/4

1. Recorder lock setting

ON – lock on,
OFF – locked off.

2. Starting recording mode (Holter method)

Fig. 3.1.3.2. Waiting for confirmation of registration start

Starting the Holter registration mode, saves the new device cycle, starts
recording and deletes all previously performed examinations.

During manual programming, you can opt out at any stage without losing your
saved examinations or previous settings.

3.2. Battery replacement

Remove the battery cover located on the bottom of the recorder, remove the used
batteries and insert new unused LR6 (AA) alkaline batteries in accordance with the
code on the case. You can also use batteries with a capacity of at least 1000 mAh.

Batteries undergo a self-discharge process so they should be charged

immediately before inserting them into the recorder.

The state of battery charge is indicated graphically (four-stage scale) in the status
bar. When the batteries have reached the state of total exhaustion or when
discharged batteries have been used, a graphic message and a beep are displayed.

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Fig. 3.2.1. Discharged batteries

In the case of detection of unusable batteries, the recorder goes to sleep mode
after displaying the appropriate message.

Please note that leaving batteries in the unused recorder or using faulty, faulty
batteries may cause damage.

Due to environmental aspects, used batteries should be disposed of in

containers specially designed for this purpose.

3.3. Patient preparation

Carefully apply the cuff to the patient's left arm in a manner appropriate to a classic
blood pressure monitor. The cuff must not be loose. The cuff pressure hose can point
up or down, it only depends on the convenience of the recorder user. The end of the
cuff should be approximately 5 cm above the elbow.

Fig. 3.3.1. Cuff location and running the pressure hose

During the measurement (pumping and deflation), the cuff applied to the forearm
must be at the level of the heart, and the patient should be relaxed and stand still.

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Pressure hoses must not be twisted or clamped, as this can lead to reduced
accuracy of the measurements being made.

The medical personnel performing the examination should, through the

observation of the limb and a preceding medical interview with the patient, be
absolutely certain that putting on the cuff, or in particular the cuff with the metal
clasp, will not cause the patient any impairment of blood circulation and,
consequently, a threat to health and life.

The cuff should be checked regularly (once a month) for leakage.

3.4. Start of measurements recording

After programming the desired recording parameters (using ASPEL 508 ABPM
software or manually), preparing the patient (a mock-up, pressure line) and inserting
new batteries, the recorder will start working. Then place the recorder in a dedicated
bag and fasten the patient's belt in the area between the hip and pelvic belt.

The first measurement will be made according to the programmed schedule.

Before placing the recorder in a dedicated bag, the first measurement can always
be made, regardless of the schedule, by pressing the event button.

Fig. 3.4.1. Location of the recorder

Personnel setting up a patient recorder should inform the patient to relax as

much as possible and not talk during the measurement procedure.

3.5. Event button

The event button is used to:

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3. starting the measurement, when the recorder is in sleep mode, it is in the

recording mode and is blocked,
4. waking up the recorder when the recorder is in sleep mode and is not
blocked,
5. starting the measurement when the recorder is awake,
6. interruption of measurement when the recorder is currently measuring.

When the recorder starts measurement and the patient is not ready, pressing the
event button will stop measurement and the patient has time to prepare. On the
other hand, when the patient feels a sudden change in blood pressure, he can
start an additional measurement process by pressing the event button.

Additional measurements, triggered by the event button, are also saved in the
recorder's non-volatile memory, just like programmed measurements.

Personnel setting up the recorder for a patient should inform the patient about
the functionality of the event button.

3.6. Completion of measurements recording

3.6.1. Locked device (automatically programmed)

The registration of measurements is completed: after removing the batteries from the
recorder, when the batteries are discharged or when the measurement memory is
full.

3.6.2. Non-locked device (manually programmed)

The registration of measurements is completed: after removing the batteries from the
recorder, when the batteries are discharged, when the measurement memory is full
or by manual completion of registration.

In the recorder's menu you should go to programming and confirm the end of the
registration.

Fig. 3.6.2.1. Waiting for confirmation of registration stop

After removing or depleting the battery, all measurements made and other data
saved in the recorder's non-volatile memory are not deleted.

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3.7. Measurement reading

Before using the ASPEL 508 ABPM software, read the instructions for using the
software.

The blood pressure measurements taken from the recorder are read through the
ASPEL 508 ABPM software. Using a USB cable, the recorder should be connected
to a PC / laptop computer with ASPEL 508 ABPM licensed software installed. The
software also allows you to perform a number of activities related to the
measurement data processing.

After reading examinations from the recorder through the ASPEL 508 ABPM
software, the recorder is unlocked and the recording mode is turned off.

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4. Advanced features
4.1. Date and time settings
When the recorder is unlocked and the recording mode is not switched on, it is
possible to manually set the current date and time.

In the recorder menu, go to programming (proceeding in accordance with advanced

manual programming) and set the date and time, then leave the menu without going
any further.

Fig. 4.1.1. Date and time settings

The date is saved in the format dd/mm/yy.

The date and time are changed without entering registration mode.

4.2. Battery type choise

When the recorder is unlocked and the recording mode is not enabled, it is possible
to select the battery type manually.

In the menu of the recorder, go to the programming (follow the advanced manual
programming) and select the battery type, and then not going further back from the
menu.

Fig. 4.2.1. Battery type choise

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There are 2 types of batteries to choose from:

1. BAT - alkaline batteries,

2. AKU - batteries (e.g. Ni-MH or Li-Ion).

Inadequate selection of the battery type may result in the recorder not being able
to perform the maximum number of measurements.

The battery type is changed without activating the recording mode.

4.3. Pediatric settings mode

When the recorder is unlocked and recording mode is not enabled, it is possible to
set the paediatric mode manually.

In the menu of the recorder, go to the programming (follow the advanced manual
programming) and set the paediatric mode, and then do not go further back from the
menu.

Fig. 4.3.1. Pediatric settings mode

The pediatric mode is set without the need to start recording mode.

4.4. Manometer test

The recorder has a manometer test function, which enables the measurement of
static pressure within the nominal blood pressure range.

In the recorder's menu, go to the service and then select the manometer option.

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Fig. 4.4.1. Starting the manometer test

A static pressure in the range 10 mmHg to 290 mmHg shall be supplied to the cuff
tubing socket for verification.

The calibration procedure should be performed by service personnel.

Rys. 4.1.2. Manometer test

7. Main measuring track (CH1)

8. Additional measuring path (CH2)

4.5. Manufacturer’s settings

The recorder has a number of settings that can be modified by ASPEL 508 ABPM
software or manually. All these settings can be reset to manufacturer default values.

Restoring manufacturer’s settings does not erase the stored patient data or
research.

In the recorder menu, go to the service and then select the manufacturer’s settings
option and accept the selection.

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Fig. 4.5.1. Restoring manufacturer’s settings

After accepting the manufacturer’s settings restore, the recorder will automatically
restart.

4.6. Airtightness test

The recorder has an airtightness test function, which enables automatic verification of
the correct operation of the device, the tightness of valves, sensors, pump and the
tightness of the used cuff.

Airtightness test can be performed for each cuff with which the recorder
cooperates.

The selected cuff should be connected to the socket of the recorder's cuff cable. The
cuff should be rolled up and fastened with Velcro.

Fig. 4.6.1. Cuff position for airtightness test

An unrolled cuff can lead to the failure of the airtightness test.

In the recorder's menu, go to the service and then select the airtightness test option
and accept the selection.

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Fig. 4.6.2. Starting the airtightness test

When the airtightness test is activated, the recorder will start pumping and the
automatic test procedure. The whole test may take several dozen seconds. Positive
completion is indicated by an appropriate message.

Fig. 4.6.3. Successful completion of airtightness test

The airtightness test with any other message is a failure, e.g. a leaky cuff.

4.7. Device unlocking

The recorder can be unlocked even after automatic locking via ASPEL 508 ABPM
software.

In order to prevent the change of settings during automatic blood pressure

measurement and/or loss of data, it is not recommended to give the patient the
procedure to unblock the recorder.

The unblocking procedure prevents accidental unblocking of the recorder.

When the recorder is dormant, start measuring with the Event button, then press the
Event button again to put the recorder in an emergency stop state.

Fig. 4.5.1. Emergency stop condition

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Then, in a short time using the keyboard, enter the following sequence of key
presses (in succession):

Fig. 4.5.2. Unlock sequence

After successfully entered sequence a longer beep will appear - the recorder is
unlocked.

Unlocking the recorder does not stop the registration mode.

In order to minimize the risk of changes in settings during automatic blood

pressure measurement and / or data loss, the recorder is unlocked only for the
time until the next sleep.

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5. Maintenance and technical support

5.1. Cleaning, disinfection, maintenance, servicing
To clean the recorder casing and cuff, it is recommended to use a soft cloth
moistened with a solution of warm water and detergent.
Do not use solvents or other caustics to clean.
Do not use materials that scratch surfaces.
Cleaning agents should be diluted before use as recommended by the
preparation manufacturer.
Do not allow the cleaning agent to get inside the device.
Do not leave cleaner on the device.

For disinfection use commonly available specialized means for disinfecting

medical devices, e.g. INCIDIN, BACILLOL, DESCOSEWPT, SEKUSEPT,
ALDEWIR, HEXAQUART, BIGUASID, IMPULS, GIGASEPT FF etc.

The efficiency of the recorder shall be checked periodically (once a year). The
inspection shall be performed by the manufacturer's service or authorized
service center. It should include inspection of: current consumption,
functionality and technical condition of the recorder, condition of the cuff and
cuff tube, tightness of the pressure measurement track and pneumatic track,
protection against excess pressure and control of the recorder measuring
parameters - at least points for 50 mmHg and 200 mmHg pressure values in
mode manometer.

Apart from periodic scheduled (warranty and post-warranty) inspections of the

recorder (once a year by the manufacturer, or an authorized service point), the cuff
cable, cuff, state of the recorder's battery pocket and the tightness of the system
should be checked on an ongoing basis.

The inspection should consist in a visual check and evaluation if there are no cracks,
pits or damage to the contacts. Any anomalies found should be removed with the
assistance of a service center.

5.2. Enviromental protection

When in use, the recorder does not generate environmentally hazardous residues.

A worn recorder should be managed properly. It can be done by sending it back

to the manufacturer or contacting a company that recycles electronic and
electromechanical devices..

5.3. Customer service

To get help with troubleshooting any problems related to the recorder’s operation,
please contact the ASPEL S.A. department.

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5.4. Troubleshooting
The recorder communicates problems related to its operation and the course of
measurement using short error codes displayed on the screen in the form
"#nnnnnn". Trying to determine the cause of the problem, note down the code
displayed.

Codes starting with "# 1 ..." or "# 2 ..." inform about the problematic course of the
measurement and can usually be resolved without the service.

Codes starting with "# 3 ..." indicate the probability of a fault and their regular
occurrence requires service.

Fig. 5.4.1. Sample error codes returned by the recorder

Problem Solution

The measurement ended The measurement has been disturbed.

with code "#1..."
Ensure that the patient remains stationary during the
or measurement interrupted measurement. Check if the cuff is in place correctly.
by code "#3128”
Verify cuff size.
Check that the cuff tubing is correctly routed and has no bends or
kinks, and is properly seated on the outlet connector.
If the "# 106" code repeats, check the cuff, tubing and detachable
quick connector for leaks.

Measurement interrupted or Check that the cuff tubing is correctly routed and has no bends or
terminated by code "#2…” kinks, and is properly seated on the outlet connector.
If after starting the measurement from the recorder the pump does
not sound or is intermittent, contact the service.

Measurement interrupted by Wait for the recorder to restart or manually reset it by

one of the codes "#3..." disconnecting the USB cable or removing the battery. Repeat
measurement.
If the situation persists, contact the service.

The recorder does not allow Probably the recorder is in menu browsing mode, where some
to load tests or communication functions are limited.
programming, even though
Use the keyboard to leave the menu and try again.
the USB cable is connected.

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Problem Solution

The device does not turn on This is a normal situation.

after inserting the USB
The recorder has previously gone to sleep mode and should be
cable.
woken up using the event button.

The recorder does not Check if the recorder's clock is set correctly. Verify the
perform measurements correctness of the recorded measurement zones: use the 'i' (Info)
when it should, performs menu to go to the list of zones and check if they are programmed
them less often or more according to previous arrangements.
often than assumed.
If not, the device must be programmed again.

The device does not display This is the normal mode of operation that is intentionally selected
measurement results, by the operator (doctor or nurse).
instead it displays the
padlock symbol.

The recorder has not Make sure that the batteries are inserted correctly. In case of
collected the measurements doubt, it is recommended to perform a test measurement on the
in the assumed period of batteries (without USB cable) before releasing the recorder to the
time even though it was set patient.
for long-term recording.

The recorder displays the The recorder has suffered a serious failure. Contact service.
red 'x' symbol in the upper
left corner of the screen and
does not allow
measurements to be made.

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6. ATTACHMENT A - Electromagnetic compatibility

declaration
Guidance and manufacturer’s declaration–electromagnetic immunity
The Recorder ASPEL 308 ABPM is intended for use in the electromagnetic environment specified below. The customer or the
user of the Recorder ASPEL 308 ABPM should assure that the device is used in such an environment.
Emission test Compliance Electromagnetic environment - advices
The Recorder ASPEL 308 ABPM uses RF energy (radio
frequency)
RF emission EN 55011/
Group 1 only for its internal functions. Therefore, its RF emissions are very
CISPR 11
low and are not likely to cause any interference in nearby
electronic equipment.
RF emission EN 55011/ The Recorder ASPEL 308 ABPM is suitable for use in all
Class B
CISPR 11 applications (environments).
Harmonic Emission
Not applicable ---
EN 61000-3-2
Voltage Fluctuations and
Flicker Emission Not applicable ---
EN 61000-3-3

Guidance and manufacturer’s declaration–electromagnetic immunity

The Recorder ASPEL 308 ABPM is intended for use in the electromagnetic environment specified below. The customer or the
userof the Recorder ASPEL 308 ABPM should assure that the device is used in such an environment.
Immunity test EN 60601-1-2 test level Compliance level Electromagnetic environment – advices
Electrostatic discharge ±8 kV (contact) ±8 kV (contact) Floors should be made of wood, concrete or
(ESD) ceramic tiles. If floors are covered with
±2 kV, ±4kV, ±8 kV, ±15 kV ±2 kV, ±4 kV, ±8 kV, ±15 synthetic material, the relative humidity
IEC 61000-4-2 (air) kV (air) should be at least 30%.

Electrical fast transient ±2 kV (for power supply

(BURST) lines)
Not applicable ---
IEC 61000-4-4 ± 1 kV (for signal lines)

Surge ± 1 kV between line (lines)

and line (lines)
IEC 61000-4-5 Not applicable ---
± 2 kV between line (lines)
and ground
Voltage dips, short <5 % UT
interruptions and (>95 % dip in UT)
voltage variations on for 0.5 cycle and 0º, 45º
power supply input ,90º ,135º ,180º, 225º, 270º,
lines (PQT) 315º angle

IEC 61000-4-11 <5% UT

(>95% dip in UT)
for 1 cycle and 0º angle Not applicable ---

70% UT
(30% dip in UT)
for 25 cycles and 0º angle

<5 % UT
(>95% dip in UT)
for 250 cycles and 0º angle
Magnetic field of 30 A/m 30 A/m Power frequency magnetic fields should be
electrical grid frequency (50 Hz / 60 Hz) (50 Hz / 60 Hz) at levels characteristic of a typical location
(POWERM) in a typical commercial or hospital
environment.
IEC 6100-4-8
NOTE: UT is the AC mains voltage prior to application of test level.

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Guidance and manufacturer’s declaration–electromagnetic immunity

The Recorder ASPEL 308 ABPM is intended for use in the electromagnetic environment specified below. The customer or the
user of the Recorder ASPEL 308 ABPM should assure that the device is used in such an environment.
Compliance
Immunity/resistance
EN 60601-1-2 test level level Electromagnetic environment – advices
test

3 Vrms
3 Vrms
150 kHz ÷ 80 MHz
RF conducted
interference
EN 61000-4-6 6 Vrms
ISM and amateur radio
6 Vrms
bands between
150 kHz ÷ 80 MHz a)

RF radiated
3 V/m
interference 3 V/m
80 MHz ÷ 2,7 GHz Portable RF communication equipment, e.g. phones
EN 61000-4-3
(including peripheral devices such as antenna cable and
27 V/m external antennas) should be used no closer than 30 cm
27 V/m (12 in) to any part of Recorder ASPEL 308 ABPM,
385 MHz
including cables specified by the manufacturer.
28 V/m
28 V/m
450 MHz Field strength from fixed RF transmitters, specified by
local measurement b) should be no smaller than
9 V/m compliance level in every frequency range c).
9 V/m
(710, 745, 780) MHz
Close-field free of radio
28 V/m
devices 28 V/m
(810, 870, 930) MHz
EN 61000-4-3
28 V/m
28 V/m
(1720, 1845, 1970) MHz
28 V/m
28 V/m
2450 MHz
9 V/m
9 V/m
(5240, 5500, 5785) MHz
a)
ISM bands (industrial, science and medical) between 0,15 MHz ÷ 80 MHz to 6,765 MHz ÷ 6,795 MHz; 13,553 MHz ÷ 13,567
MHz; 26,957 MHz ÷ 27,283 MHz; and 40,66 MHz ÷ 40,70 MHz. Amateur radio bands between 0.15 MHz ÷ 80 MHz to 1.8 MHz ÷
2.0 MHz; 3.5 MHz ÷ 4.0 MHz; 5.3 MHz ÷ 5.4 MHz; 7 MHz ÷ 7.3 MHz; 10.1 MHz ÷ 10.15 MHz; 14 MHz ÷ 14.2 MHz; 18.07 MHz ÷
18.17 MHz; 21.0 MHz ÷ 21.4 MHz; 24.89 MHz ÷ 24.99 MHz; 28.0 MHz ÷ 29.7 MHz and 50.0 MHz ÷ 54.0 MHz.
b)
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 Recorder ASPEL 308 ABPM is used exceeds the applicable RF compliance level above,
the Recorder ASPEL 308 ABPM should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Recorder ASPEL 308 ABPM.
c)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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7. ATTACHMENT B – Cooperation of the ASPEL 308

ABPM recorder with a PC
7.1. Introduction
The ASPEL 308 ABPM recorder is a medical electrical device meeting the relevant
safety requirements.

The USB ports used in the recorder for communication and power supply from a PC
allows the recorder to cooperate with an electrical device not for medical use, thus
creating a medical electrical system.

7.2. General requirements for medical electrical systems

The medical electrical system should provide:
o a level of safety in the patient's environment equivalent to that of a medical
electrical device conforming to EN 60601-1; and
o outside the patient's environment, a level of safety equivalent to that of a device
complying with the relevant IEC or ISO safety standards.

1,5 m

1,5 m

1,5 m

Rys.7.1.2. Example of patient environment

Non-medical electrical equipment, when used in a medical electrical system, shall

comply with the IEC or ISO safety standards applicable to the equipment concerned.

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A device in which protection against electric shock depends solely on basic insulation
should not be used in a medical electrical system.

Responsible institutions are reminded that the installation of medical electrical

systems and modifications during the service life are subject to an assessment
of compliance with the requirements of EN 60601-1.

The responsible entity can be e.g. a hospital, a single doctor or a non-

professional. In home applications, the patient, operator and responsible unit
may be one and the same person.

All non-medical devices that meet the safety standards appropriate to their original
use and are placed in the patient's environment require measures to limit the tactile
current if it exceeds the following values:
o in the normal state, touch current from or between parts of the medical electrical
system in the patient's environment: 100 μA,
o in the event of a break in any uninstalled protective ground wire, touch current
from or between parts of the medical electrical system in the patient's
environment: 500 µA.

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