Monitor Monidrop W Manuel utilisateur
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
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 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.
8
• 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
10
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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