B.Braun Perfusor fm - Frank`s Hospital Workshop

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Document text

Perfusor® fm 


Instructions for Use 























Software PFAE 


BBRAUN 


Patient safety 


Attention: Consult accompanying documents ! A 











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


Operation 

> Make sure unit is firmly in position. This 
applies in particular to use with infusion 
stands or wall rails. Never place more than 3 
Perfusor fm units on top of one another. 


> Prior to use: 

Always check audible and visual alarms. This 
likewise applies where appropriate to the staff 
call. 


» Patient connection should only be made 
when device is switched on. 

Interrupt connection when changing syringe 
to avoid danger of incorrect dosage. 


> Make sure syringe is correctly positioned. 


> Whenever inputs are made, value displayed 
is to be compared to value entered. Do not use 
unit unless values coincide. 


> Appropriate cannulas/catheters are to be 
used for the administration set/med. applica- 
tion. 


> Make sure there are no kinks in tubing; 
ensure unimpeded flow. 


» Make exclusive use of disposables. Replace 
after 24 hours. 


> Use only compatible combinations of 
equipment, accessories, working parts and 
disposables. 


> The use of not recommended resp. 
incompatible disposables may influence the 
technical specifications. 


> Operational reliability is only guaranteed if 
use is made of accessories which have been 
tested/authorised and thus recommended by 
the manufacturer, B. Braun. 


> Installation in medically used rooms must 
comply with the appropriate regulations (e.g. 
VDE 0100, VDE 0107 or IEC- publications). 
Observe national specifications and deviations. 


> The infusion lines should be placed in such a 
way that the syringe cannot be pulled out of its 
fixation because of uncontrolled drawing. 


> Possible explosion hazard if used in presence 
of flammable anaesthetics. 


Other components 
> These must conform to the same 
requirements as the administration set. 


> Where several infusion lines are connected 
on one singular vascular access the possibility 
of their exerting a mutual influence vice- versa 
cannot be excluded. 


> Operation in the occlusion pressure range 
may affect accuracy. 


Safety Standards 

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


The EMC- requirements (electro-magnetic 
compatibility) according to IEC/EN 60601-1-2 
and IEC/EN 60601-2-24 are fulfilled. If the 
equipment is operated in the vicinity of other 
equipment which may cause high levels of 
interence (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 12). 
Interferences may occur e.g. at electro- 
magnetic fields > 10 V/m resp. electro- 
magnetic discharges > 8 kV. 








Perfusor fm® 





The Perfusor fm is a transportable infusion 
syringe pump in accordance with IEC/EN 
60601-2-24 that is suitable for dispensing 
liquids in nutritional and infusion therapy. The 
medical specialist must decide on suitability 
for application on the basis of the warranted 
properties and the technical data. 


For further details please refer to these 
Instructions for Use. 


The Perfusor fm is used primarily for the highly 
precise, reproducible infusion of medication in 
large and small quantities. The device permits 
extremely exacting delivery rate settings, and 
thus optimal adaptation to any given 
requirements. 


The drive system ensures reliable gripping of 
the syringe on pressing the appropriate key, 
which in turn makes for optimal start-up and 
considerably facilitates handling when 
inserting the syringe. 


Contents 

Overview page 4 
Operation page 6 
Special Functions page 8 
Reasons for Alarm page 12 
Cleaning / Battery page 13 
Start-up graphs and trumpet curves page 14 
Technical data page 16 
Warranty page 18 
Order Data page 19 


9- stage pressure limitation provides extra 
safety. Pressure values and trends are 
displayed during infusion. In the event of a 
pressure alarm, the bolus volume built up by 
the Perfusor fm is automatically reduced. In 
addition, operation of the unit can be made 
even more reliable if required with double 
entry of the rate. 


Special functions broaden the scope of 
applications. Additional memory cards can 
provide yet more functions, for example 
conversion to patient- controlled analgesia 
(PCA). 


Overview 





Function keys 

The function of the 4 keys is governed by the 

respective situation. This is indicated in the 

display above. Thus, for example: 

SF Call up special functions 

+/- Increase /Decrease 

END Exit from this selection and return to 
normal display 

-- Key has no function 

If MOM lights: Press key again to confirm entry. 


m Display and user prompting 
All important data are given in plain language 
or can be called up. 


Display with unobtrusive green light for 
optimum legibility. (Mains only. With battery 
only during unit operation.) 














VOL TIME RATE SF 


VOL Infusion Volume 

Press key beneath VOL. 

Enter volume (between 1 and 999.9 ml) and 
confirm entry. 


TIME Infusion time 

Press key beneath TIME. 

Enter time (e.g.: 50 min. as 5 0 or 2 h 30 min 
as 2 3 0) and confirm entry. 


RATE Delivery rate 

Press key beneath RATE to confirm calculated 
rate from volume and time input. 

Press key beneath RATE* (if MOM lights). 


* Only displayed with rate calculation. 





Syringe holder 
Holds syringe in position. To remove syringe: 
Pull and move to the left. 


SF Special functions 

If released, successive call-up of: Dosage 
Calculation / Bolus function / Standby function / 
Drug selection / Occlusion pressure / Battery 
capacity / Data lock / Contrast / Date, Time. 


Settings (Service only) 

> Ward code (displayed when unit switched off) 
> Range of syringes 

> Range of drugs 

> Deactivation of individual special functions 








Pole clamp, back Aluminium casing 

Attach to infusion stand. Fit Easy upkeep, drip- proof and resistant to 
Perfusor fm from above and disinfectant. 

engage. To release, press 


black button. Memory- card window 


Scope of functions can be extended for 
exemple by way of a PCA memory card (please 
ask for into anon 











—— Keypad for input 





~~ Correction/CLEAR key 
Resets display to 000.0 


— Main switch ON/OFF ; 
Press for 2 seconds to switch off. OX Alarm Indicator 
Lights in alarm situation. 


=}; — Delivery rate 














Remaining battery capacity 
With device switched off and power lead O© Operating Indicator 
disconnected: Briefly press OI® . Indicates delivery. 

Battery capacity (and ward if envisaged) 3© Battery Check 


is indicated after 3 seconds. Lights when using battery. Flashes with battery 





Suppress alarm tone for 2 min pre-alarm. 

l — START/STOP ŒO Mains Check 
Start/interruption of infusion, e.g. for altering Lights during mains operation. Battery is 
delivery rate. charged. 


Infrared interface 
For operation with fluid manager system. 


Handle for easy transport 









Slide-in memory card unit 
pellicle 
— 
m= Power supply 
For operation with fluid manager system. 


Y Potential equalisation 

Connect with CF-mode. 

-J+ CF- application (cardiac floating), 
defibrillator- proof 

















Multi- function- connector (MFC)* 
Connecting for staff call, ambulances (12 V DC) Mains connection 


and interface for fm anaesthesia/intensive. Connection for power lead.Automatic 
switching to battery in the event of power 
* As of unit no. 20001. Previously separate connections failure. Mains fuses directly above mains 
for staff call and 12 V supply. connection. 


Operation 


Start of infusion 


> Ensure reliable installation 
Connect up staff call if appropriate. 


> Switch on unit with O/O. A short self-test is 
performed. Drive moves into position. 


» Open syringe holder 


> Insert syringe 

Grip plates of syringe must be vertical and held 
securely by locator (see diagram). Close syringe 
holder. 


> Grip syringe 

Keep key beneath << pressed. Drive advances 
and grips pressure plate of syringe, then release 
key. Type of syringe indicated must coincide 
with syringe inserted. 


> Prime 

Press key beneath ON until infusion set has 
been primed (pressing key once = 1 ml). Then 
press key beneath END. 


> Connect up to patient 


> Set delivery rate 
Values between 0.1 and 200 ml/h. Check 
display! Correction: Press C, enter rate again. 


Choose additional settings as described below. 
For automatic rate calculation: Do not enter 
rate! 


> Press START 

Infusion is implemented. Running symbol 
appears on display and green operating 
indicator lights. 


Syringe change 


To avoide incorrect dosing, always interrupt 
patient connection when changing syringe. 


b> Press STOP 

Green operating indicator goes out. Close 
patient access. 

> Remove empty syringe 

Open syringe holder. Press key beneath >>, 
drive moves backwards. 


> Insert new syringe 
Grasp plunger, vent and connect up to 
patient as described. 


»> Press START 


End of Infusion 


> Press STOP 
Green operating indicator goes out. 
Close patient access. 


b> Remove syringe 
Open syringe holder. Press key beneath >>, 
drive moves backwards. 


> Switch off 
Press O/@ for 2 seconds. 


Additional settings 





To Change the Delivery Rate 
» Press STOP. 


» Press C. Display is reset to 000.0. 
» Enter new delivery rate. 


» Press START. Infusion is implemented. 
(Alarm is given if there is no restart 
within 2 minutes) 


To Change the Rate Without Interrupting the 
infusion (Function can be deactivated by our 
Service staff) 


p> Enter new rate. 


» Press key beneath RATE. Rate is transferred 
to red display. Unit operates at new rate. (If 
new rate is not confirmed within 10 s, infusion 
continues at old rate) 


Target Volume (Volume Pre- selection) 

The target volume will be administered inde- 
pendent on the infused volume. 

» Press key below VOL. 

» Enter target volume via keypad and confirm 
with VOL (values between 0.1 and 999.9 ml). 
After confirming the display shows the residual 
volume instead of the target volume. 


Note: When target-/residual volume has been 
administered, the pump stops and goes into 
alarm. Acknowledge alarm and press VOL. Clear 
displayed residual volume with C (in display 
appears ----,- ml). Confirm this with VOL or 
enter new target volume. To continue infusion, 














UU UU ee 


= EH 
° nn TOBE 8 
Aone E 








S Make sure syringe is properly inserted 


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 beneath TIME. 

Enter target time via keypad and confirm with 
TIME (50 min. =5 0; 2 h/30 min. = 2 3 0). After 
confirming instead of the target time the resi- 
dual time is displayed. 


» Correction: Press C. Display --h --m. 
New entry. 


Note: When time has been expired, the pump 
stops and goes into alarm. Acknowledge alarm 
and press TIME. Clear displayed residual time 
with C (in display appears --h -- m). Confirm 
this with TIME or enter new target time. 


Rate calculation 
Displayed delivery rate must be 000.0. 


» Enter volume and time. The delivery rate 
is calculated automatically and displayed 
(rounded to one decimal place). 


> Confirm RATE. 
> Press START. Infusion is implemented. 


Clear Time/Volume 
> Press STOP, then key beneath VOL or TIME. 


» Press C to clear. 
1x: Target Vol/Time = ----.-ml / --h--m 
2x: Infused Volume/Real Time = 0.0ml /00h00m 


Status Request 
Only when infusion is running. 


» Press 1 x resp. 2 x key below INFO for 
actual values. The display disappears after 10 
sec or after all information has been requested. 


» Press x times key below INFO for displaying 
syringe type, battery capacity in h and min as 
well as hours of operation. 


Set rate is automatically reduced if required 
for type of syringe being used. 


Special functions 


Select special functions SF 
Depending on the version, several functions 
may be deactivated. Contact service. 


> To set special functions, press key below SF 
repeatedly until desired special function is 
displayed. - Then follow Instructions for Use as 
described. 


Activate Bolus Function 
For additional boli. 


» Pressing key below ON activates the 
function (values are maintained after switching 
on again). 


To change bolus rate: 

» Press key below RATE. Enter new value 
and confirm RATE. - Correction: Press C and 
re-enter. 





Note: Keep bolus rate low to ensure required 
dosing accuracy. Example: At a rate of 
1,800 ml/h, 0.5 ml of bolus volume are 
administered per second. 


Exit bolus function: 
» Press key below END. 


Bolus application during infusion: 
Bolus with volume pre- selection. 
» Press key below BOL and release. 
Display: BOLUS RELEASE? 


> Enter bolus. Values between 0.1 and 50.0 ml 
(if no entry is made within 10 sec., function is 
automatically exited). 





» Press key below YES. Bolus is administered. 
After the bolus application the infusion 
continues at basic rate. 


To stop bolus: 
» Press key below STOP. 
Bolus without volume pre- selection 


» Press and hold BOL until a second BOL is 
displayed. 


> Hold both BOL-keys. Bolus is administered 
as long as both 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 time runs auto- 
matically. Exit function with END, set basic 
rate and start. Remaining interval time 

is displayed in h:min:sec. A bolus on demand 
is possible at any time during infusion at the 
basal rate. 


Bolus and dosage calculation 

> Operation as in volumetric mode. Depending 
on the settings in ml (volume), quantity of 
active agent (e.g. mg) or in quantity of active 
agent per kg weight (mg/kg) the bolus may be 
administered. During bolus administration all 
three values are displayed. 


Standby/Pause 
In case of extended interruptions set values are 
maintained. 


p> Press STOP. 


» Press key beneath SF until "Standby" is 
displayed. 


» Press key beneath ON. 


> Enter length/duration of interruption 
interval or confirm time displayed. 


Correction: Press C. Display 00h 00m. 
New entry. 


> Confirm TIME. Timer for interruption 
on display is running. Alarm at the end of 
interruption interval. 


Check Battery Capacity 

Remaining battery life time is displayed, e.g.: 
Time = 02h 30 min 

In addition the operating hours are displayed. 


To switch off display again: 
Press key beneath END. 


> With unit switched off and power lead 
detached: Briefly press O/@. Short display of 
remaining battery life time after 3 sec. 


» Device switched off and power lead 
connected: Permanent display of remaining 
battery life time. 


Battery replacement is recommended if a 
remaining life time of less than 2 hours is 
displayed after 16 hours charging time. 


Drug Display 
9 selectable drug names can be stored (input 
via service program only). 


> Select with key beneath (+). Drug is 
displayed also during infusion. 


> Key beneath CLR deletes drug name from 
display. 


> Exit selection: Press key beneath END. 


Occlusion Pressure 
For shorter alarm triggering times, occlusion 
pressure limit can be adjusted in 9 stages. 


Optimum setting: 
Max. 2 - 3 bars can be seen in the course of 
infusion. 


> Set value between 1 and 9 with key 
beneath (+) or (-). 


> Exit selection: Press key beneath END. 


Data / Clock 
Interlocks keys to prevent unauthorised use. 


» Press key beneath ON. Keys are interlocked. 


» Key release: Press decimal point key, then 
key beneath OFF. 


> Exit data lock: Press key beneath END. 


Set Date/Clock 
» Set date. Press key below DAT, enter date 
and confirm with DAT. 


> Set time. Press key below TIME, enter time 
and confirm with TIME. 


> Exit selection: Press key below END. 


B Continued on next page 


9 


Special functions 


Dosage Calculation (Overview) 
The dosage calculation automatically calculates 
the delivery rate in ml/h. Setting parameters: 


1. Syringe concentration 
per ml or 
quantity per syringe filling volume 


Entry: mcg, mg, IU or mmol, each from 0.001 
to 99999. (5-digit, decimal point counts as one 
digit. Exception is syringe volume: there only 
2- digit.) 


2. Selection for weight and time- related or 
only time- related dosage. Entry of body 
weight: from 0.01 kg to 200 kg. 


3. Entry of dosage: 


a) Weight and time-related in mcg/kg, mg/kg, 
IU/kg, mmol/kg, each per /min, /h or /24 h. 


b) Time-related only in mcg, mg, IU or mmol, 
each per /min, /h or /24 h. 


Dosage Calculation (Operation) 
» Press key below SF repeatedly until DOSAGE 
CALC. OFF appears. 


» Press key below ON. 


> Concentration: At first select quantity unit. 
Select with key below ug?. 


Note: After numerical entry change of quantity 
unit is not possible anymore. (Remedy: delete 
numbers). 


> Enter syringe concentration by moving 
flashing star to desired entry position with 
arrow keys. Confirm all numbers with OK. 


Entry of syringe concentration per 1 ml or per 
syringe filling. 


» For dosage by body weight enter body 
weight and confirm. Otherwise confirm 0 kg. 
(With OFF complete termination of all dosage 
settings.) 


10 


> After confirming value weight with OK select 
dosage requested (quantity- and time unit). 


> Enter values (at flashing star as described) 
and confirm with OK. Automatically calculated 
values (rate or dosage) are displayed. 


> Check first rate displayed for plausibility, 
then confirm RATE. Rate appears in red display. 


> Start infusion. 


Note: Dosage (e.g. 5 mg/kg/h) is displayed (down 
on the right). 


As the automatically calculated value of the rate 
is rounded, the dosage value may change 
insignificantly. 


Info Request 
> Press key below INFO. 


1x: Infused Volume, Run Time 

2x: Infused Volume, Actual Dose 

3x: Selected Syringe Type 

4x: Battery Capacity, Operating Hours 


Change Rate / Dosage 
» Press stop. 


> Enter new dosage value and confirm with 
RATE. 


> Start infusion again. 


Change Rate or Dosage 

without Interruption of Infusion 

During infusion a star is flashing down on the 
right. 


> Enter new value and confirm with RATE. 
Pump operates with new rate / dosage. 


Note: Alternatively the star can be moved with 
the arrow key to change the rate in ml/h. 


Change Syringe Concentration 

with Dosage Calculation Activated 

Note: Always out of basic menu. 

If necessary, press END until display basic menu 
is VOL TIME -- SF. 


» Press key below SF repeatedly until DOSAGE 
CALC. ON appears and confirm 
with OK. 


» Clear syringe concentration with C. 
Enter new value and confirm. 


Change Dosage from Basic Menu 

» Press key below SF repeatedly until DOSAGE 
CALC. ON appears and confirm 

with OK. 


> Confirm concentration with OK. 
> If active, confirm weight with OK. 


> Change values (move flashing star as 
described) and confirm entries with OK. 


> Check entered or calculated rate for 
plausibility and confirm with key below RATE. 
Rate appears in red display. 


p> Start Infusion. 


Switch off dosage calculation 

> The dosage calculation remains activated 
until it is switched off in Special Functions. If 
the Perfusor fm is switched off in the mean- 
time all previous values except the body weight 
are maintained. 


Switch off from Basic Menu 
» Press key below SF repeatedly until display 
DOSISCALC.ON. 


» Press DOSISCAL.OFF. 
Dosage calculation is deactivated. 


> With key below END back to basic menu. 


Interface 


Interface Operation: 
Connection to interface input via M FC- plug. 
Interface descriptions available from B. Braun. 


Remote Control 

Via fm controller possible. When using a 
commercially available external computer this 
must satisfy the requirements acc. to IEC/EN 
60601-1 as well as the single- fault fail- safe 
condition acc. to IEC/EN 60513. 


Send Proposal 

The delivery rate and a drug can be entered in 
the Perfusor fm as "proposal" via an external 
computer. Both items of data must be checked 
on the Perfusor fm and acknowledged. 


Documentation 
All operating data of the Perfusor fm can be 
requested and logged via external computer. 


11 


Reasons for alarm 





Operating alarms Device Alarms 


Remedy failure and restart infusion When display indicates "device alarm" an 


Pressire alàrm audible alarm sounds permanently. 


> Occlusion? - Check the free flow and insert > Press ON/OFF- key repeatedly until display 
infusion line free of kinks. Bolus is automatically indication "do not press any key until display is 
reduced. off". Pump switches off automatically after a 


> Press START for renewed infusion. few seconds. 


> Switch on device again. In case of repeated 
Battery alarm device alarm inform service. 
» Battery pre-alarm 3 min. before battery is 


discharged. 


> Then battery alarm: 
Yellow battery indicator flashes. 
Red alarm indicator is on. 
Audible alarm every 4 s. 
Operating indicator off. 
Staff call. 


> Switch off unit. Connect to mains. 


Syringe alarm 
Fault on syringe replacement? Manipulation of 
syringe holder during infusion? 


» Pull syringe holder. 


Syringe pre-alarm 

> 3* min before syringe empty: 
- Display: Syringe pre- alarm. 

- Audible alarm every 9 s. 


*Time can be set by our Service staff to between 3 and 30 min. 


> If syringe empty: 
Display: Syringe empty. 
Operating indicator off. 
Audible alarm every 4 s. 
Staff call. 


Standby alarm 

» Alarm after pre-selected pause? 

To terminate pause: Press key beneath END. 
To extend pause: Press key beneath ON. 


Further alarms/displays 
> Display: No rate? Set rate. 


12 


Cleaning / Battery 





Regular checking, cleaning, 
disinfection 


Check regularly 

> Self-check, audible alarm, process- and 
alarm control. Use only according to 
Instructions for Use. 


» Cleanliness, completeness, damage. 
> Function of staff call (if connected). 


Cleaning 
» With standard household cleaners, soap and 
water solution. 


Wet disinfection 

> Only use surface disinfection agents. Do not 
use spray disinfectant at mains connection. 
Before operation the device allows to vent for 
at least 1 min. B. Braun recommends 
Meliseptol. 


Service 
> Servicing must be carried out exclusively by 
personnel instructed by B. Braun. 


» Carry out safety check every 24 months. 


> Use only original spare parts and 
accessories. 


12 V mains operation or 
battery 


> Check mains voltage as per type plate. 


> Plug in power lead at rear (screw in 12 V 
lead in ambulance car). 


> In case of power failure or if 12 V DC/230 
V AC is not connected the unit automatically 
will be switched to integrated rechargeable 
battery. 


Charge Battery 
» Charge battery in case of 
first use, 
battery alarm, 
non-use for more than 2 months. 


Battery is charged - even during infusion - 
if 12 V=== or 230 V AC are connected. 


Charging time 
»> Approx. 16 hours. Longer charging is not 
detrimental. 


Capacity 
A fully charged battery is sufficient for more 
than 3.5 hours with delivery rates < 25 ml/h. 


Rechargeable batteries ageing 
After 2 years, the original capacity is only 
approx. 50 %. 


» The life time of the battery can be exten- 
ded by completely discharging from time to 
time and recharging afterwards. 





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 
Perfusor fm, mains lead, Pole clamp, 
Instructions for Use. 








13 


Start- up graphs and trumpet curves 





M ax. bolus volume 




















1,0 ml Max. bolus volume according to 
0,9 pressure stage and syringe type 
0,8 
0,7 
0,6 



































0,4 
0,3 
0,2 
on al 
0 1 2 3 4 5 


8 9 


Pressure 

















Start-up graphs /trumpet curves 


The graphs on page 7 are designed to show the accuracy/ 
uniformity of flow versus time. 


Note: The delivery behaviour/delivery accuracy is essentially 
influenced by the types of syringe used (disposables). 
Significant deviations may be encountered if use is made of 
syringes (disposables) other than those stated in the order 
data. 


Trumpet curves 

Measured values for second and last hour in each case. 
Measurement intervall At = 0.5 min 

Observation interval p -At [min] 


Start- up graphs 

























































































io ml Omnifix a 20 ml OPS ol 50 mlOPS Measurement interval At = 0.5 min 
Measurement duration T = 120 min 
Flow Q, (ml/h) 
2(mi/h) flow 10 ml Omnifix 10% deviation 10 ml Omnifix 
Delivery rate = 1 ml/h 1 ml/h 
1,5 5 | Epmax 
i 
T 
AREON 
Los = Epmin 
o 30) 60 90 t (min) 120 2 5 " 19 pAt (min) 31 
10 (mi/h) flow 10 ml Omnifix 10% deviation 10 ml Omnifix 
Delivery rate = 5 ml/h 5 ml/h 
7,5 5 Epmax 
6 ae an Oe a a a, T 
Epmin 
-5 
1 
0 30) 60 90 t (min) 120 2 5 11 19 pAt (min) 31 
2(mi/h) flow 20 mi OPS ho% deviation 20 ml OPS 
Delivery rate = 1 ml/h 1 ml/h 
Epmax 
/ 
-0,5 ma ‘ T epi 
o 30| 60 90 t (min) 120 2 5 1 19 pAt (min) 31 



























































































































































20 (ml/h) flow 20 mi OPS 10% deviation 20 mi OPS 
Delivery rate = 10 ml/h 10 ml/h 
15 
Epmax 
FAV AVAVAYAUAYWA AVA AVA AAA MAAA VINCI AU TN AMMAM MAMMAM 
10 to 
Epmin 
5 -5 
o 30 60 90 t (min) 120 2 5 1 19 pAt (min) 31 
2(mi/h) flow 50 ml OPS 10% deviation 50 mi OPS 
Delivery = 1 ml/h 1 ml/h 
15 5 ME See 
Epmax 
AMAMMA WAM in \AN ae Sa 
Lo. 
Epmin 
0,5 Ep 
0 30 60 90 t (min) 120 2 5 1 19 pAt (min) 31 
50 (ml/h) flow 50 mİ OPS 10% deviation 50 ml OPS 
Delivery rate = 25 ml/h 25 ml/h 
37,5 5 
Epmax 
25 Lo- 
Epmin 
12,5 -5 
0 30 60 90 t (min) 120 2 5 ii 19 pAt (min) 31 


























Alarm signalling times co /irfe (min) 20 mi OS 
aad 
\ 
The graphs show the alarm signalling times aan 
in dependence on pressure stage and type of alk x 
syringe. ae 
Stage 1 Stage 5 Stage 9 ee 
© 1 a Delivery‘rate (ml/h 
6° |Time (min) 10 ml Omnifix 
50- 
40 
30 
20 
10 ` 
"u TD E 3 e e (ml/h) o 1 Z 3 Delivery'rate (ml/h) 
































15 


Technical data 


Type of unit 
Classification (acc. to IEC/EN 60601-1) 


Class (acc. to Directive 93/42 EEC) 
Moisture Protection 
Rated voltage/current 


External extra-low voltage 
Staff call 


Interference suppression EMC 


Time of operation 


Operating conditions 
Relative humidity 
Temperature 
Atmospheric pressure 


Storage conditions 
Relative humidity 
Temperature 
Atmospheric pressure 


Type of battery 

Operating time of rech. battery 
Recharging time 
Weight/dimensions (WxHxD) 


16 


Syringe Pump 
{VF defibrillator- proof; Type CF 


Protection Class | 
Il b 


IP 22 (drip protected for horizontal use) 


230 VAC (0.07 A), 50/60 Hz 
Fuse 0.2 A slow-blow (IEC 127) 


200/230/240 VAC switch- selectable 
(0.07 A) 50/60 Hz 
Fuse 0.2 A slow-blow (IEC 127) 


100/110/120 VAC switch- selectable 
(0.15 A) 50/60 Hz 


Fuse 0.4 A slow-blow (IEC 127) 
12 V = 


Max. 24 V/1 A/24 VA 
Arbitrary connection polarity (VDE 0834) 


EN 55011 (CISPR 11), 
EN 60601-1-2 (IEC 601-1-2) 


100 % (continuous operation) 














30 % ... 90 % (without condensation) 
+5 °C... + 40 °C 
500 mbar ... 1060 mbar 


10 % ...90 % 
- 25°C... + 55°C 
500 mbar ... 1060 mbar 


NiCd (rechargeable) 6 x 1.2 V; 1.2 Ah 
>16h 

>16h 

approx. 3.5 kg / 360x110x170 mm 


Accuracy of set delivery rate 


Delivery range 

Delivery pre- selection 
Occlusion alarm pressure 
Settings for bolus function 


Alarm in case of incorrect delivery 


+2 %, measuring time > 1h, min. 2 ml 
(including disposables approved by 
manufacturer) 


0.1 - 200.0 ml/h 
1 - 999.9 ml (in 1 ml increments) 
9- stage (approx. 0.2 bar...1.0 bar + 0.2 bar) 


Rate 1 ml/h to 1800 ml/h 
Volume 0.1 ml to 50.0 ml 
Interval time 1 min. to 99 h 59 min. 


In case of incorrect delivery < 0.01 ml due to 
apparatus malfunction the pump switches off 
automatically. 

















Syringe table 
Manufacturer Display / Type Syringe size / Reference article number 
10/12 ml 20 ml 50/60 ml 
B. Braun Perfusor 8728615 8728810 
Proinjekt 8728917 
Omnifix 4617100 4617207 4617509 
Euroject 4630505 
Becton B-D Plpak 300912 309661 300865 
Dickinson 300912 300913 300869 
300134 309663 
300629 
Terumo Terumo EU SS*10L SS*20L BS50LG 
SS*60L 
TYCO (in the past Monoject EU 1100-6121173 1100-620036 1100-650030 
Kendall/Sherwood) Monoject US 8881-512878 8881-520657 8881-560125 

















* (Plastipak) 


For pre-selection of syringes at the Perfusor 
use reference list of article numbers. If syringes 
from manufacturers are used with different 


article numbers (similar) constructed than 
mentioned in the above table, please contact 
the original manufacturer directly. 





Warranty 





Manufacturer responsibility 


Manufacturer, assembly and installation 
personnel or instructors can only be held 
responsible for any effects on device safety, 
reliability and performance if 


- Installation, expansion work, readjustments, 
modifications or repairs are carried out by 
personnel authorised by the above and 


- The electrical wiring in the room concerned 
satisfies the requirements of VDE 0100, 0107 
and/or IEC publications and 


- The device is operated in line with the 
instructions for use. 


Warranty 


B. Braun provides 24 months' warranty as of 
the date of delivery for every Perfusor fm. This 
includes the repair or replacement of damaged 
parts as a result of design/manufacturing 
errors or material defects. Modifications or 
repairs to the unit by the owner or third 
parties invalidate the warranty. 


The warranty does not cover the elimination of 
faults attributable to incorrect/inexpert 
handling or normal wear and tear as well as 
rechargeable batteries. 


18 


The CE mark confirms compliance with the 
"Council Directive on Medical Products 93/42/ 
EEC" dated 14th June 1993. 


B.Braun Melsungen AG 


Service 


The Perfusor fm is sturdy and hard- wearing. It 
nevertheless requires a safety check and the 
appropriate entries in the equipment log book 
every 2 years. 


2-yearly maintenance is recommended. This is 
best achieved by calling in Service. Individual 
consultation enables allowance to be made for 
the specific conditions in a given hospital. 


A complete service manual can be provided if 
required, however only in conjunction with 
technical instruction. 


Order Data 


Original Perfusor syringe: 


50 ml with draw- off cannula 
50 ml without draw- off cannula 

50 ml with draw- off cannula and particle filter 

50 ml with draw- off cannula and particle filter, with light protection 


20 ml with draw- off cannula 
20 ml without draw- off cannula 

20 ml with draw- off cannula and particle filter 
20 ml Omnifix 


Omnifix syringe 10 ml 








Adapter for 10 ml syringe 


Original Perfusor tubing: 

N,PVC, with Luer lock connectors,pressure- resistant, 150 cm 

L,PVC, with Luer lock connectors,pressure- resistant, 200 cm 

MR,PVC, with Luer lock connectors,pressure- resistant, 75 cm 

M,PVC, with loose lock nut on patient end, pressure- resistant, 150 cm 

PE,PE, with Luer lock connectors, pressure- resistant, 150 cm 

S,PVC, light- protected, with Luer lock connectors,pressure- resistant, 150 cm 
PES, PE, light- protected, with Luer lock connectors,pressure- resistant, 150 cm 
MK,PVC, with cannula, with Luer lock connectors, pressure-resistant, 75 cm 
PVC, with sterile filter 0.22 u, with Luer lock connectors, pressure- resistant, 200 cm 


Perfusor fm 


Recommended accessories for Perfusor fm 

MFC- Connecting lead for staff call 

Connecting lead for potential equalisation 
MFC-Connecting lead for ambulance car (12 V) 
MFC-RS 232 interface cable with electrical isolation 
Y- cable for central power supply for 2 Perfusors 


Art. No. 


872 8810F 
872 8844F 
872 8852F 
872 8828F 


872 8623F 
872 8615F 
872 8631F 
461 7207V 


461 7100V 
870 0117 


872 2960 
872 2862 
872 2870 
872 2994 
872 2935 
872 2919 
872 3010 
872 2889 
872 3001 


871 3820 


871 1682 
870 1628 
871 1674 
871 1661 
870 0109 


19 


B BRAUN 


HOSPITAL CARE 


Drawing no. M 637 010 014 F04d Raw material no. 3891009/8 
05/01 Printed on pulp bleached 100% chlorine-free 


B. Braun Melsungen AG 
Postfach 1120 
D-34209 Melsungen 


Tel (05661) 71-0 
Fax (05661) 71- 20 44