Monidor Monidrop W User manual
MONIDOR
Operating
manual
EN
Software version 1.X.X
0598
Monidrop W
Infusionmonitor
®
2
CONTENTS
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 Notications 16
4.1 Notications 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 notications 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 specications 25
10 Operating instructions for accessories 31
CONTENTS
4
1 Monidrop® W infusion monitor / General
1.1 General
Green light:
Infusion in progress
Yellow light:
Notication
Drip detector
Latch,
press to open
Screen
Charging port is locat-
edatthebottomofthe
device.
1 GENERAL
Brackets for
various drip
chambers.
Notication
button
Powerbutton
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 gures.
Note the correct po-
sitioning of dierent
types of drip cham-
ber models! More
detailed 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
6
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
7
1.3 Patient safety
1.3.1 Purpose of use
The Monidrop® W infusion monitor is intended for the periodic
or continuous measurement of parenteral uids via an intrave-
nous 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 a roller clamp or a
ow regulator 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 sta must determine the suitability of the device for the
intendedpurpose ofuse onthebasisofdevicepropertiesandtechnical
specications.
1.3.2 Use
• Users of the Monidrop® W infusion monitor must read this op-
erating manual before using the device. A Monidor salesperson
or another authorised person must provide the rst guidance
of use.
• Make sure that the device is rmly 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 the uid regulator or so
that a continuous stream drips into the drip chamber.
• The device is intended for use indoors in a stable operating
environment. 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 pow-
1.3 PATIENT SAFETY
Monidrop® W DOES NOT ADJUST the infusion rate. ALWAYS use a
roller clamp or a uid regulator to adjust the infusion rate.
8
erful spotlight or a ashing uorescent tube. In this case,
the measurement accuracy cannot be guaranteed.
• The device must not be used during magnetic resonance imaging
(MRI).
• The Monidrop® W infusion monitor is designed as a measuring
device for the administration of maintenance uids, nutrition-
al 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.
• TheMonidrop®Winfusionmonitoralwaysusesml/h(millilitresper
hour) as the measuring unit for the infusion rate.
• Make sure that uids can ow 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 manu-
facturer’s recommendations (note country-specic hygiene
regulations).
• The operating conditions of the device must full proper
requirements (e.g. VDE 0100, VDE 0107 or IEC regulations). Note
country-specic guidelines and dierences.
• 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.
1.3 PATIENT SAFETY
9
• If the device drops or suers 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 more than 20 degrees, its measurement accuracy cannot be
guaranteed.
• 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 selected 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 signicantly high ows
(continuous drip) if the roller clamp or the uid regulator is fully
opened. In these cases, the device may not give a direct notication.
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 infu-
sion 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
10
1.3.4 Other infusion factors
• Check the compatibility of the products and medicine used
from the manufacturers’specications.
1.3.5 Safety standards
• The Monidrop® W infusion monitor fulls all safety regulations
of standards IEC/EN 60601-1 and EN 60601-1-11:2015 on medi-
cal electrical equipment.
• The device fulls electromagnetic compatibility (EMC) require-
ments in accordance with standard IEC/EN 60601-1-2 and
publications Draft EN 301 489-1 V2.2.0 and Draft EN 301 489-17
V3.2.0.
• This product is compliant with Directive 2014/53/EU. The rele-
vant Declaration of Conformity is available at www.monidrop.
com.
• If the device is used in the proximity of other devices that may
cause signicant interference (e.g. high-frequency surgical
equipment, computed tomography equipment, infrared trans-
mitters, 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
11
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/O
Notication 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
Notication
2 SYMBOLS / MENU STRUCTURE
12
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
13
Main screen (measurement view)
The top row indicates the device status; battery
status, infusion rate and notication sound.
Treatment duration
Current infusion rate
Liquid volume administered during treatment
If the line in the adjacent gure 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
14
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
position. 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 or the uid
regulator.
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 rmly in place and in an upright posi-
tion.
3. Use the roller clamp or the uid regulaor to set the infusion rate.
The measurement result is shown by the Monidrop® W device.
4. The Monidrop® W device gives notication if the infusion rate is
over 1200 ml/h or the battery status is low.
5. Press the notication button on the front of the unit if you want
to activate or deactivate notications when infusion rate is less
than 6 ml/h or when battery status is low.
3 USING THE DEVICE
15
Note: Attaching dierent 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 sti,
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
ALWAYS 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 o 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 o 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)
seconds. When the device is switched o, any previously set data and
settings will be reset.
3 USING THE DEVICE
16
4 Notications
The Monidrop® W infusion monitor is equipped with its own notica-
tion system (notication sound and optic notication).
Noticati-
on type
Noti-
cation
tone
Optic notication Acknowledg-
ment
Yellow
LED
Red
LED
Text/image
Visual no-
tication
No Conti-
nuous
Blinking
triangle
Automatic
once the
reason for the
notication
has been
removed
Sound no-
tication
Yes Blin-
king
Blinking
triangle
Automatic
once the
reason for the
notication
has been
removed
Self test
notication
Yes Conti-
nuous
Error code
(Check
chapter
4.1.3.)
The device
can be
switched o
and restarted
4.1 Notications
4.1.1 Infusion rate is less than 6 ml/h
You can activate the notication by pressing the notication button
on the front of the device . The message is displayed with a
ashing yellow light and sound and the screen displays a ashing
notication triangle at the infusion rate symbol.
• Notication when infusion rate is less than 6ml / h
4 NOTIFICATIONS
17
4.1.2 Battery low
The device gives notication with a blinking yellow light, a notication
tone and a ashing triangle at the infusion rate symbol.The message is
automatically cleared when the device is connected to the charger.
• The device gives notication when the battery status is down to
10%.
4.1.3 Infusion rate is over 1200 ml/h
The message is displayed with a ashing yellow light and sound and
the screen displays a ashing notication triangle at the infusion rate
symbol.
• Notication 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 notication by
emitting a continuous red light and tone, and all device functions
will be locked. The device can be switched o 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 notications
Audio notications can be muted and activated using the noti-
cation button. The mute symbol is displayed at the top of the
display, when the ”less than 6ml/h notication”is set to mute.
By default, the notication for an infusion rate below 6 ml/h
is muted each time the device is turned on.
Pressing the audio notication button a second time activates the
audio notications if the infusion rate falls below 6 ml/h
4 NOTIFICATIONS
18
5 Battery charge and maintenance
The Monidrop® W infusion monitor is equipped with a rechargea-
ble lithium 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
connected 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 o 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
Monidrop® 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
connected 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 tempera-
ture and the battery is fully charged. The battery capacity dis-
played is indicative. If the battery is older, the actual operating
period may dier 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 discon-
nected from the mains power receptacle in the event of an emergen-
cy.
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 signicant 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
solution. 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 con-
tent of up to 2%, dilution 1:10
Note: Do not immerse the device in any uid or spray any water or
cleaning agent on the device.
Note: Do not use a cleaning stick to touch or press the protective lm
behind the speaker holes and bars.
6 CLEANING
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