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Responsibility of the Manufacturer

The manufacturer, assembler, installer or
importer considers himself responsible for the
effects on safety, reliability and performance of
the equipment only if:

• assembly operations, extensions, re-adjust-

ments, modifications or repairs are carried 
out by persons authorised by him,

• the electrical installation of the relevant 

room complies with the appropriate require-
ments (e.g. VDE 0100, 0107 and/or the IEC-
publications resp. national requirements),

• the equipment is used in accordance with 

the Instructions for Use and

• the Technical Safety Checks are carried out 

regularly.

Warranty

B. Braun provides as from the date of delivery a
warranty of 2 years for every Infusomat® fmS.
This covers repair or replacement of parts dama-
ged as a result of design/manufacturing errors
or material defects. Modifications or repairs to
the unit undertaken by the owner or by third
parties invalidate the warranty.

The warranty does not cover the following: 
Elimination of faults attributable to
incorrect/inexpert handling, or to normal wear
and tear and rechargeable batteries.

Technical Safety Check*

)

/ Service

The Technical Safety Check is recommended to
be carried out every 2 years and should be
documented.
Servicing work must be carried out exclusively
by personnel instructed by B. Braun.

Check regularly

Check for cleanliness, completeness and
damage. Use only according to Instructions for
Use. Check each time when switching on: self-
check, audible alarm, process- and alarm control
indication.

Cleaning

Clean using mild soap suds. Do not use spray
disinfectants at the mains power connection.
Recommended: disinfectant for wiping available
from B. Braun (e.g. Meliseptol®).
Before operation the device allow to vent for at
least 1 min. Do not spray into openings in the
device. Be sure to observe the instructions
provided concerning waste disposal and hygiene
for batteries and disposables.

18

Warranty / TSC

*)

/ Service / Cleaning

The CE mark confirms that this medical prod-
uct complies with the "Council Directive on
Medical Devices 93/42/EEC” dated 14

th

June

1993.

B. Braun Melsungen AG

Inspection on Delivery

Despite careful packaging, the risk of transport
damage cannot be entirely prevented. Upon
delivery, please check that nothing is missing.
Do not use a damaged device. Contact the
service department.

Items included

Infusomat® fmS, Power Cord, Drop Sensor, Pole
Clamp, Instructions for Use.

Содержание 871 5416

Страница 1: ...Infusomat fmS Instructions for Use Software IFME IFMe ...

Страница 2: ...turer 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 public...

Страница 3: ...e 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 specifie...

Страница 4: ...ess 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 ...

Страница 5: ...of mains power failure the pump switches to battery operation Battery operation time 3 5 h at highest delivery rate Automatic over load 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 F...

Страница 6: ...cessary 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 di...

Страница 7: ...yed residual volume with C in display appears target volume ml and confirm with VOL If desired enter new target volume To continue infusion the target volume has to be displayed as ml or a new target volume has to be set Target Time Time Pre selection Press key below TIME Enter target time via keypad 50 min 50 2 h 30 min 2 3 0 Confirm Press key below TIME again instead of the target time the resid...

Страница 8: ...device alarms At the moment of an event also the volume infused from switching on is recorded The history function is activated ex works After a software update the function has to be installed again service programme menu 560 calibration history card With this programme the function also can be deactivated A faultless time related recording requires exact setting of time and date Recording the da...

Страница 9: ...h keys are pressed Per ml bolus administered a short audible signal sounds Interval bolus Automatic bolus in set time interval In case of manual bolus administration the interval bolus is skipped Select bolus function under SF Press key below VOL TIME or RATE Enter values and confirm After value below TIME has been confirmed interval times runs automati cally Exit function with END set basal rate ...

Страница 10: ...as necessary for drop control to appear Press key below OFF no drop control appears To switch on again Press key below ON Exit from selection Press key below END Check Battery Capacity Remaining battery life time is displayed e g battery capacity 02 h 30 min In addition the operating hours are displayed To switch off display again Press key below END With device switched off and mains power lead d...

Страница 11: ...sired quantity and time unit Enter values at flashing star as described and confirm with OK Automatically calculated values rate or dosage are displayed First check rate displayed for plausibility then confirm RATE Value is displayed Start infusion Note Dosage value with unit is displayed down on the right As the automatically calculated value of the rate is rounded the dosage value may change ins...

Страница 12: ... primary rate and volume and confirm The softkey PIGY only will be displayed after a target volume had been entered before Press key below PIGY enter piggyback rate and volume and confirm Start infusion Pump delivers the piggyback volume with the set piggyback rate As soon as the programmed piggyback volume has been infused delivery continues with keep open rate KOR resp after 30 min KOR operation...

Страница 13: ...essing key The alarm continues in short intervals until the bat tery is fully discharged Battery Alarm Alternately rate and AAA A are displayed The text display shows battery discharged connect to mains battery indicator flashes red alarm indicator is on audible alarm every 4 sec operating indicator off staff call Switch off device Connect to mains power or 12 V DC power source KOR Alarm KVO Pre a...

Страница 14: ...atteries Ageing After 2 years the original capacity is only approx 50 The lifetime of the battery can be extended by completely discharging from time to time and recharging afterwards Interface Interface Operation Connection to interface input via MFC plug Interface descriptions available from B Braun Send Proposal The delivery rate and a drug can be entered in the Infusomat fmS as proposal via an...

Страница 15: ...0 deviation 2 5 11 19 p t min 31 Epmax Epmin 0 The graphs show the accuracy uniformity of flow in relation to time Allow for the following The delivery behaviour resp delivery accuracy is essentially influenced by the types of disposables used Significant deviations may be encountered if use is made of disposables others than those stated in the order data Trumpet Curves Measured values for second...

Страница 16: ...cted at appliance inlet External extra low voltage 12 V DC Staff call Max 24 V 1 A 24 VA Arbitrary connection polarity VDE 0834 EMC EN 55011 IEC EN 60601 1 2 and IEC EN 60601 2 24 Time of operation 100 continuous operation Operating conditions Relative humidity 30 90 without condensation Temperature 10 C 40 C Atmospheric pressure 700 mbar 1060 mbar Storage conditions Relative humidity 10 90 Temper...

Страница 17: ...ction 0 1 9999 9 ml in 0 1 ml increments Occlusion alarm pressures Alarm reaction time Max bolus volume measured at 22 C with OIL infusion set Mechanical occlusion pressure limit Occlusion alarm pressure max 1 6 bar 160 kPa under fault conditions max bolus volume 2 ml Alarm in case of incorrect dosage In case of incorrect dosage of max 0 6 ml due to apparatus malfunction the pump switches off auto...

Страница 18: ...echnical Safety Check Service The Technical Safety Check is recommended to be carried out every 2 years and should be documented Servicing work must be carried out exclusively by personnel instructed by B Braun Check regularly Check for cleanliness completeness and damage Use only according to Instructions for Use Check each time when switching on self check audible alarm process and alarm control...

Страница 19: ... 870 1644 Original Infusomat infusion set CVP with line for CVP measuring 340 cm 870 0010 Original Infusomat infusion line 250 cm 870 0036 Original Infusomat infusion set 5 µm with 5 µm filter 275 cm 870 0052 Original Infusomat infusion set K with injection port 270 cm 870 0087 Original Infusomat infusion line S black for light sensitive drugs 250 cm 870 0125 Original Infusomat infusion set E for ...

Страница 20: ...terial No 3891 2341 Drawing No M671010100F04 05 01 Printed on pulp bleached 100 chlorine free B Braun Melsungen AG P O Box 11 20 D 34209 Melsungen Tel 49 0 56 61 71 0 Fax 49 0 56 61 71 20 44 HOSPITAL CARE ...

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