B Braun Infusomat fmS User manual

Infusomat®fmS

Instructions for Use

Software IFME/IFMe

Attention: Consult accompanying documents!

Operation

➤ Ensure the unit is properly positioned and

secured.

➤ Prior to use check audible and visual alarms

during self test. Also check the device for possible
damage.

➤ If staff call is used we recommend to check the

equipment once after connecting the pump.

➤ Connect to patient only after switching on the

device. Interrupt the connection during changing
administration set(s) to prevent incorrect dose
delivery.

➤ Select cannula/catheter suitable for use with the

intended medical application.

➤ Position the infusion line free of kinks.
➤ Recommended change of disposables after 24 h

(consider national hygiene regulations).

➤ Compare displayed value with entered value.

Start infusion only if values are corresponding.

➤ Installation in medically used rooms must comply

with the appropriate regulations (e.g. VDE 0100,
VDE 0107 or IEC-publications.

➤ Possible explosion hazard if used in presence of

flammable anaesthetics!

➤ Air in line cannot be detected by the air detector

at stop-cocks, infusion ports and additional
administration set components.

Other components

➤ Variations in pressure (e.g. as caused by change

of level) can affect the accuracy of the device.

➤ Where several infusion lines are connected on

one single vascular access the possibility of their
exerting a mutual influence vice-versa cannot be
excluded.

➤ Refer to respective manufacturer’s information

for possible incompatibilities of equipment resp.
drugs.

➤ Use only compatible combinations of equipment,

accessories, working parts and disposables.

➤ It is recommended to use original Infusomat®

infusion lines only.

➤ The use of not recommended resp. incompatible

disposables may influence the technical specification.

➤ Connected electrical equipment must comply

with the relevant IEC/EN-publications
(e.g. IEC/EN 60950 for data-processing equipment).
The user/operator is responsible for the system
configuration if additional equipment is connected.
The international standard IEC/EN 60601-1-1 has to
be taken into account.

Safety Standards

The Infusomat® fmS satisfies all safety standards for
medical electrical devices in compliance with
IEC/EN 60601-1 and IEC/EN 60601-2-24.

➤ The EMC-limits (electro-mangnetic compatibility)

according to IEC/EN 60601-1-2 and IEC/EN
60601-2-24 are maintained. If the equipment is
operated in the vicinity of other equipment which
may cause high levels of interference (e.g. HF surgical
equipment, nuclear spin tomography units, mobile
telephones etc.) maintain the recommended protec­tive distances for these devices. Under certain
conditions malfunctions may occur which lead to a
device alarm with permanent alarm tone (see also
alarm conditions, page 13). Interferences may occur
e.g. at electro-magnetic fields > 10 V/m resp.
electro-magnetic discharges > 8 kV.

Special Function "without drip control”,

see page 10.

Read Instructions for Use prior to use. Application only under regularly supervision by specially trained staff.

Patient Safety

Infusomat®fmS

Contents

Infusomat® fmS / Overview Page 4

Operation Page 6

Additional Settings Page 7

Special Functions Page 8

Alarm Conditions Page 13

Start-up Graphs and Trumpet Curves Page 15

Technical Data Page 16

Warranty / TSC*)/ Service / Cleaning Page 18

Ordering Page 19

*

)

Technical Safety Check

The Infusomat® fmS is according to
IEC/EN 60601-1 resp. IEC/EN 60601-2-24 a
volumetric infusion pump for infusion of small
and large volumes at highest accuracy and is
suitable for intravenous and intra-arterial
applications, for blood transfusion and for
enteral nutrition.

The medical specialist has to decide on the
suitability of the application. The decision has
to be made on the basis of the specified
properties and technical data.

For further details please refer to the
Instructions for Use.

3

4

Handle

For easy transport.

Holder for Drop Chamber

Prevents unintended
movement (swaying).

Adapter for Drop Sensor

Replaceable, depending on drop
chamber size. Press lateral and pull
off.

Universal Pole Clamp

Attach the Infusomat® fmS from
above, clicking into its place. To
release, press the black button.

Overview

Display

All important information in plain text. Green
background illumination only if connected to
mains or a key is pushed at battery operation.

Correct Input/CLEAR

Display reset to 000.0

Red LED indicates alarm condition

Additionally "AAA.A” is flashing in the display.
Possible alarms: "drop alarm, air alarm, pressure
alarm, pump-door open, battery alarm,
standby-alarm”

Keypad for Input

Operating Indicator

Additional operating control indicator in display.

5

Guide for Short Infusion Pole

VOL Infusion Volume

Press key below VOL. Enter volume
(0.1 ... 9999.9 ml). Confirm. Press again key
below VOL.

TIME Infusion Time

Press key below TIME. Enter time e.g. 50 min as
5 0 or 2 h 30 min as 2 3 0. Confirm. Press again
key below TIME.

RATE Delivery Rate

Only active when rate is calculated automatical­ly. The key below RATE confirms the calculated
rate.

SF Special Functions

If activated: dose calculation / bolus function /
standby / drug selection / occlusion pressure /
drop control / piggyback / battery capacity /
data lock / contrast / date, time.

Function Keys

Mains/Power Connection

(protect against ingress of moisture). In case of
mains/power failure, the pump switches to
battery operation. Battery operation time:
> 3.5 h at highest delivery rate. Automatic over­load protection. Mains fuse: directly above the
mains/power connector.

Potential Equalisation

To be connected for CF-applications.

Aluminium Housing

Easy-care, drip water protected, resistant to
disinfectants.

Mains/Power Supply

For operation with fluid manager system.

Multi-Function­Connector (MFC)

Connection for staff
call, ambulances
(12 V DC) and inter­face for fm anaes­thesia/fm intensive.

Optical Interface

Infrared Interface for operation on
"fluid manager system”.

Flow Inhibitor

Opening door clamps off infusion line
automatically.

Peristaltic Pump

For precise and reliable dosage.

Door Opener

Special Functions "SF”

Function Keys (Soft keys)

Mains/Power Switch ON/OFF

Suppress alarm tone for 2 min

Infusion START/STOP

Infusion

1. Ensure reliable installation

Never position infusion bottle below pump level.

➤ Connect staff call.
➤ Insert spike vertically into infusion bottle.

Fill lower part of drop chamber to max. 2/3.

➤ Open roller clamp.

2. Filling and Venting

Fill infusion line from bottom to top.

➤ Close roller clamp.

3. Insert Infusion Line

Press door opener.

➤ Insert infusion line: Locate clips first on top,

then on bottom.

➤ Keep infusion line in place at air sensor.
➤ Close door. In the area of the peristaltic

pump segments and free-flow clamp the
infusion line will be positioned self-acting.

➤ Open roller clamp completely. There may not

be a continuous drip.

➤ Place drop sensor on drop chamber

(if necessary, use an appropriate adapter).

4. Switch On with

Green mains/power control or yellow battery
control, alarm tone and display LED’s are briefly
activated.

5. Puncture

6. Setting the Delivery Rate

In the range: 0.1 - 999.9 ml/h and check
(selectable in 0.1 ml/h-increments).
Correction: Press C, then set new rate. Select

additional settings, if desired (see page 7).

7. Press START

Operating symbol appears on the display and
the green operating indicator lights.

8. Stop the infusion

➤ Press STOP. Green operating indicator goes

out

➤ Close roller clamp.
➤ Press door opener. Infusion line will be

clamped off when opening the door.

➤ Remove infusion line. First bottom, then

top.- Replacement: Insert new infusion line as
described. Then press START again.

➤ To end switch off

Press for 2 sec.

Operation

6

Original
Infusomat®
line with
silicone-pump
element

upper clip

free flow clamp

lower clip

air sensor