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 Notications 16
4.1 Notications 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 notications 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 specications 25
10 Operating instructions for accessories 31
CONTENTS

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1 Monidrop® W infusion monitor / General
1.1 General
Green light:
Infusion in progress
Yellow light:
Notication
Drip detector
Latch,
press to open
Screen
Charging port is locat-
edatthebottomofthe
device.
1 GENERAL
Brackets for
various drip
chambers.
Notication
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 dierent
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

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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 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
specications.
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-specic hygiene
regulations).
• The operating conditions of the device must full proper
requirements (e.g. VDE 0100, VDE 0107 or IEC regulations). Note
country-specic guidelines and dierences.
• 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 suers 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 signicantly 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 notication.
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

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1.3.4 Other infusion factors
• Check the compatibility of the products and medicine used
from the manufacturers’specications.
1.3.5 Safety standards
• The Monidrop® W infusion monitor fulls all safety regulations
of standards IEC/EN 60601-1 and EN 60601-1-11:2015 on medi-
cal electrical equipment.
• The device fulls 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 signicant 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