Monitor Monidrop W User manual

MONIDOR
Operating
manual
FI
Software version 1.X.X
0598
Monidrop W
Infusion monitor
®

2
SISÄLTÖ

3
1 Monidrop® W infusion monitor / General 4
1.1 General 4
1.2 Attaching Monidrop to a drip chamber 5
1.3.1 Purpose of use 7
1.3.2 Use 7
1.3.3 Blood transfusion 9
1.3.4 Other infusion factors 10
1.3.5 Safety standards 10
2 Symbols / Menu structure 11
3 Using the device 14
3.1 Activation and start of infusion 14
3.1.1 Preparations 14
3.1.2 Starting the device 14
3.1.3 Starting infusion monitoring 14
3.2 Starting a new treatment 15
3.3 Ending an infusion treatment 15
3.4 Shutting down the device 15
4 Notifications 16
4.1 Notifications 16
4.1.1 Infusion rate is less than 6 ml/h 16
4.1.2 Battery low 17
4.1.3 Infusion rate is over 1200 ml/h 17
4.1.4 Self-test program and forced restart 17
4.2 Managing audio notifications 18
5 Battery charge and maintenance 19
6 Cleaning 21
7 Warranty / Inspection and maintenance
/ Training 22
8 Content of the delivery and inspecting the content
/ Recycling 24
9 Technical specifications 25
10 Operating instructions for accessories 31
SISÄLTÖ

4
1 Monidrop® W infusion monitor / General
1.1 General
Green light:
Infusion in progress
Yellow light:
Notification
Drip detector
Latch,
press to open
Screen
Charging port is locat-
ed at the bottom of the
device.
1 GENERAL
Brackets for various
drip chambers.
Notification
button
Power button
Drip size
indication

5
1.2 Attaching Monidrop to a drip chamber
1. Open the locking
mechanism by press-
ing the locking lever
and open the latch.
2. Put the drip cham-
ber into place as
shown in the figures.
Note the correct po-
sitioning of different
types of drip chamber
models! More de-
tailed instructions on
page 6.
3. Close the latch
by returning it to the
locking position.
Note! If the lock feels
too tight, check the
correct position of the
drip chamber.
1 GENERAL
With collar Without collar
With collar Without collar

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Correct positions of drip chambers:
Place the drip chamber in the Monidrop® W device so that the air intake
cap points forwards or backwards. If the drip chamber has a collar, guide
the edge of the collar to the lower slot (Figure 1). If the drip chamber does
not have a collar, guide the drip chamber to the upper slot (Figure 2).
1 GENERAL
Figure 1. Drip chamber with a
collar
Figure 2. Drip chamber without
a collar
Front Front
Back Back

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1.3 Patient safety
1.3.1 Purpose of use
The Monidrop® W infusion monitor is intended for the periodic or con-
tinuous measurement of parenteral fluids via an intravenous route. The
Monidrop® W infusion monitor is used for dosage measurements in
intravenous therapy. The device DOES NOT set the IV dosage. Instead,
the dosage is set using the roller clamp of the infusion set. The device is
intended for use by healthcare professionals at hospitals and health care
centres and in home care.
The medical staff must determine the suitability of the device for the
intended purpose of use on the basis of device properties and technical
specifications.
1.3.2 Use
• Users of the Monidrop® W infusion monitor must read this operating
manual before using the device. A Monidor salesperson or another
authorised person must provide the first guidance of use.
• Make sure that the device is firmly in place during its use.
• Before use, check the device and its fastening mechanisms in case of
damage or any missing parts.
• Do not fully open the roller clamp or so that a continuous stream
drips into the drip chamber.
• The device is intended for use indoors in a stable operating environ-
ment. The device is not suitable for use on vehicles.
• The use of the device is not recommended for children under 10
years of age or patients of less than 20 kg, or in such situations
where the measurement accuracy should be better than ±11,8%.
• The device must not be used under direct sunlight, a powerful
spotlight or a flashing fluorescent tube. In this case, the measurement
accuracy cannot be guaranteed.
1.3 PATIENT SAFETY
!
Monidrop® W DOES NOT ADJUST the infusion rate. ALWAYS use a
roller clamp to adjust the infusion rate.

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• The device must not be used during magnetic resonance imaging
(MRI).
• The Monidrop® W infusion monitor is designed as a measuring de-
vice for the administration of basic fluids, nutritional solutions, blood
products or antibiotics. The device is not applicable for use together
with strong medicinal substances requiring high accuracy.
• Only use infusion set suitable for the device, with a drip size ALWAYS
of 20 drops (gtt)/ml and accuracy of at least ±10%. Before use,
check that the infusion set is attached correctly to the device.
• The Monidrop® W infusion monitor always uses ml/h (millilitres per
hour) as the measuring unit for the infusion rate.
• Make sure that fluids can flow freely by straightening all lines.
• The height of the IV bag should be suitable for gravity infusion. The
height should be about 60 ... 90 cm above the patient.
• Make sure that the level of the drip chamber does not reach the
measurement range. Fill the drip chamber halfway at the most.
• When replacing infusion sets, follow the infusion set manufacturer’s
recommendations (note country-specific hygiene regulations).
• The operating conditions of the device must fulfil proper requirements
(e.g. VDE 0100, VDE 0107 or IEC regulations). Note country-specif-
ic guidelines and differences.
• The device has also been approved for home care in accordance
with standard 60601-1-11.
• Do not use the device in a room containing explosive substances.
• Protect the charger against moisture.
• If the device drops or suffers a heavy impact, it must be sent to a
service point for inspection.
• Only use the charger delivered with the Monidrop W device.
• Do not tilt the device heavily when using it. If the device is tilted by
1.3 PATIENT SAFETY

9
more than 20 degrees, its measurement accuracy cannot be guaran-
teed.
• The user must always evaluate the correctness of the information
displayed before making any treatment decisions.
• Regardless of recommended limits, the values selected for treatment
must be medically correct.
• The user must ensure that patient information is correct and the select-
ed target concentrations and measured dosage rates comply with the
regulations of the country in question.
• Connection is permitted only to devices that Monidor Oy has ap-
proved.
WARNING: The device does not identify any air or bubbles in the IV line.
WARNING: The device does not identify any significantly high flows (con-
tinuous drip) if the roller clamp is fully opened. In these cases, the device
may not give a direct notification.
WARNING: Modifying this device is prohibited.
WARNING: The charger cable causes a choking hazard for small chil-
dren.
WARNING: Do not use the device if its charger or cable is damaged.
1.3.3 Blood transfusion
• The Monidrop® W infusion monitor can be used to monitor infusion
of blood products. Only use disposable products intended and
indicated for blood products. The drip size of the blood line must be
20 drops (gtt)/ml.
1.3 PATIENT SAFETY

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1.3.4 Other infusion factors
• Check the compatibility of the products and medicine used from the
manufacturers’ specifications.
1.3.5 Safety standards
• The Monidrop® W infusion monitor fulfils all safety regulations of
standards IEC/EN 60601-1 and EN 60601-1-11:2015 on medical
electrical equipment. The Monidrop® W infusion monitor fulfils the
sections applicable to infusion monitoring devices of the following
chapters of standard EN 60601-2-24: 201.7.9.2, 201.7.9.3 and
201.12.4.4.109.
• The device fulfils electromagnetic compatibility (EMC) requirements
in accordance with standards IEC/EN 60601-1-2 and IEC/EN
60601-2-24.
• This product is compliant with Directive 2014/53/EU. The relevant
Declaration of Conformity is available at www.monidrop.com.
• If the device is used in the proximity of other devices that may cause
significant interference (e.g. high-frequency surgical equipment,
computed tomography equipment, infrared transmitters, etc.), follow
the safe distances recommended for such equipment.
• If the Monidrop® W infusion monitor is used at temperatures lower
than the indicated operating conditions, it must be kept at room
temperature for at least one hour before use.
• If the Monidrop® W infusion monitor is used at temperatures higher
than the indicated operating conditions, it must be kept at room
temperature for at least 30 minutes before use.
1.3 PATIENT SAFETY

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Device or drip chamber tilted
Infusion rate more than 1,200
ml/h
Infusion rate less than 6 ml/h
Unstable drip detection
2 Symbols / Menu structure
Device symbols:
Power switch On/Off
Notification button
Näytön symbolit:
Battery status
Mute
Sound on
Drip indicator
Remotely set target limit
or limit (if used with IV Screen)
Liquid volume
Treatment duration
Infusion rate
Notification
2 SYMBOLS / MENU STRUCTURE

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Label:
Symbol Description of symbols
Note: Read the instructions delivered
with the product.
Drip size: 20 drops (gtt)/ml
Markings of electrical and electronic
equipment in accordance with direc-
tive 2002/96/EC (waste electrical and
electronic equipment)
CE marking in accordance with direc-
tive 93/42/EEC
Temperature limit
%Humidity limit
Air pressure limitation
Non-ionising electromagnetic radiation
(IEC 60417-5140)
2 SYMBOLS / MENU STRUCTURE
0598

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Main screen (measurement view)
The top row indicates the device status; battery
status, infusion rate and notification sound.
Treatment duration
Current infusion rate
Liquid volume administered during treatment
If the line in the adjacent figure is shown for the
current infusion rate, the measurement result is
uncertain or the drip cannot be detected. Check
that the drip chamber and device are straight and
correctly attached. Remove any foam from the drip
chamber.
2 SYMBOLS / MENU STRUCTURE

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3 Using the device
3.1 Activation and start of infusion
3.1.1 Preparations
1. Insert the pointed tip of the IV line into the bottle in an upright posi-
tion. Fill at most 1/2 of the drip chamber to keep the drip detection
function operational.
2. Fill the drip chamber and close the roller clamp.
3. Check that the Monidrop® W device is undamaged and contains all
the necessary parts.
3.1.2 Starting the device
1. Start the device by pressing the power button. If the device is
connected to the charger, a battery charge symbol will be displayed
on the screen and an orange light will indicate that the device is
being charged.
Note the self-test program: The device performs a self-test program during
start-up.
3.1.3 Starting infusion monitoring
1. Attach the Monidrop® W device to the drip chamber as instructed.
2. Make sure that the device is firmly in place and in an upright posi-
tion.
3. Use the roller clamp to set the infusion rate. The measurement result is
shown by the Monidrop® W device.
4. The Monidrop® W device gives notification if the infusion rate is over
1200 ml/h or the battery status is low.
5. Press the notification button on the front of the unit if you want to
activate or deactivate notifications when infusion rate is less than 6
ml/h or when battery status is low.
3 USING THE DEVICE

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Note: Attaching different types of infusion sets to the Monidrop® W
device must be done in accordance with the instructions.
WARNING: Do not apply any force when attaching the drip chamber to
the Monidrop® W device. If the fastening mechanism seems stiff, check
that the position and installation of the infusion set and clamp is correct.
• Only use infusion sets suitable for the device, with a drip size AL-
WAYS of 20 drops (gtt)/ml and accuracy of at least ±10%. Before
use, check that the line is attached correctly to the device.
3.2 Starting a new treatment
To start a new treatment, reset the previous treatment by turning the power
off for three (3) consecutive seconds . Then, restart your device to be
ready to use again.
3.3 Ending an infusion treatment
You can stop monitoring the treatment in progress by switching off the
device by pressing the power button for three (3) seconds.
3.4 Shutting down the device
Shut down the device by pressing the power button for three (3) sec-
onds. When the device is switched off, any previously set data and settings
will be reset.
3 USING THE DEVICE

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4 Notifications
The Monidrop® W infusion monitor is equipped with its own notification
system (notification sound and optic notification).
Notificati-
on type
Notifi-
cation
tone
Optic notification Acknowledg-
ment
Yellow
LED
Red
LED
Text/image
Visual noti-
fication
No Conti-
nuous
Blinking
triangle
Automatic
once the
reason for the
notification
has been
removed
Sound no-
tification
Yes Blin-
king
Blinking
triangle
Automatic
once the
reason for the
notification
has been
removed
Self test
notification
Yes Conti-
nuous
Error code
(Check
chapter
4.1.3.)
The device can
be switched
off and re-
started
4.1 Notifications
4.1.1 Infusion rate is less than 6 ml/h
You can activate the notification by pressing the notification button on the
front of the device . The message is displayed with a flashing yellow
light and sound and the screen displays a flashing notification triangle at
the infusion rate symbol.
• Notification when infusion rate is less than 6ml / h
4 NOTIFICATIONS

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4.1.2 Battery low
The device gives notification with a blinking yellow light, a notification
tone and a flashing triangle at the infusion rate symbol. The message is
automatically cleared when the device is connected to the charger.
• The device gives notification when the battery status is down to 10%.
4.1.3 Infusion rate is over 1200 ml/h
The message is displayed with a flashing yellow light and sound and the
screen displays a flashing notification triangle at the infusion rate symbol.
• Notification when infusion rate is more than 1200 ml/h
4.1.4 Self-test program and forced restart
The device performs a self-test program during start-up. If there are any
problems during the test, the device will give an notification by emitting a
continuous red light and tone, and all device functions will be locked. The
device can be switched off and restarted, in which case the device will
perform self-test program again.
If the device freezes, it may be forced to restart by pressing the power
button for an continuous period of eight 8 seconds. Contact maintenance
if the device does not start regardless of the restart.
4.2 Managing audio notifications
Audio notifications can be muted and activated using the notification but-
ton. At the top of the screen, the mute symbol is displayed when the
message is less than 6ml / h. Notifications with an infusion rate less
than 6 ml/h are always muted by default when the device is turned on.
By pressing the audio notification button a second time, the battery charge
status notification sound is also muted. Pressing the button again will
enable audible notifications for battery status and infusion rate less than 6
ml / h.
4 NOTIFICATIONS

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5 Battery charge and maintenance
The Monidrop® W infusion monitor is equipped with a rechargeable lith-
ium ion polymer battery. A new battery can be used for 72 hours on one
charge. To ensure optimal use, the device is equipped with a protective
function against overcharging and excess battery discharge (prevention of
deep discharge).
At the top of the screen, the battery status is indicated in percentage,
and the battery symbol indicates the battery status in steps. Symbols
indicate the battery status as shown below. On the left, the battery is fully
discharged and on the right, the battery is fully charged. The percentage
displayed below indicates the battery status on a rough level.
0% 25% 50% 75% 100%
The Monidrop® W infusion monitor can also be used when its battery is
being charged, and it will operate normally. When the device is connect-
ed to the charger, the middle LED at the top of the screen will be orange
when the battery is being charged and the symbol shown below will be
displayed in place of the battery status symbol.
If the battery is fully discharged, the device will go off automatically. If the
battery is fully discharged, keep the charger plugged up to one hour until
the charging light comes on. The battery can then be fully charged.
Note: Only use the charger delivered with the device to charge the Moni-
drop® W infusion monitor. Note that the device has a limited movement
range when the charger is connected.
5 BATTERY CHARGE AND MAINTENANCE

19
Instructions for the optimal use of the battery:
• Charge the battery at least once every three months.
• At the regular operating temperature, the battery can be charged
and discharged approximately 500 times before its capacity de-
creases below 80% of the maximum value.
• The battery will slowly discharge if the infusion monitor is not con-
nected to the power grid and even if the device is not in use.
• The full operating period of the battery can only be achieved when
the device is operated uninterrupted at room temperature and the
battery is fully charged. The battery capacity displayed is indicative.
If the battery is older, the actual operating period may differ from
that shown on the screen.
Note: The battery may explode or leak if it is opened or burned/heated.
Note waste handling guidelines.
Note: While the device is charged, disconnection from the mains supply
occurs by removing the charger from the AC power socket.
WARNING: While charging Monidrop during use, ensure that access
to the mains plug is not blocked so that the charger can be disconnected
from the mains power receptacle in the event of an emergency.
Battery maintenance and warranty:
The device manufacturer provides the battery with a warranty of two (2)
years. This is the typical service life of the battery (without causing any
significant reduction in the operating period). After two years, the battery
will be replaced during scheduled maintenance.
The battery can only be replaced by a service provider authorised by
Monidor.
5 BATTERY CHARGE AND MAINTENANCE

20
6 Cleaning
Wipe the surface clean using a piece of cloth and a mild soap-water solu-
tion. If required, disinfect the device using ApoWipe or a similar product.
The device can also be disinfected as follows:
• 80% isopropanol
OR
• Mild alkaline disinfectant
OR
• Phenoxyethanol + quaternary disinfectant, dilution 1:10
OR
• Chlorine-containing disinfectant, with an active chlorine content of
up to 2%, dilution 1:10
Note: Do not immerse the device in any fluid or spray any water or clean-
ing agent on the device.
Note: Do not use a cleaning stick to touch or press the protective film
behind the speaker holes and bars.
6 CLEANING