B.Braun Perfusor User manual

Perfusor® compact
Instructions for use
0123
Software AA
1
Patient Safety
Attention: take note of accompanying documents!
!
First read the Instructions for Use. Use of the equipment presupposes regular checking by specially-trained staff.
Operation
Make sure that the unit has been positioned safely and is stable and secure.
Prior to use: always ensure the functioning of the audible and visual alarms during the automatic check (see page 6). Also check the staff call and syringe setting features for possible damage.
Connection to patient is only permissible when the device is switched on. Interrupt the connection to change syringes. There is other­wise a danger of incorrect dosage.
Select syringe/catheter suitable for use with the connection system and medical application.
Make the connection ensuring that the infusion line is free of kinks so that a flow is possible.
Replace disposable articles after 24 hours.
It is presupposed that installation in rooms used for medical purposes will comply with the appropriate regulations (e.g. VDE 0100, VDE 0107 or IEC publications). Care must also be taken to observe regional specifications and national variations.
Do not use in an area endangered by risk of explosion.
Compare displayed and input values. Use only when these match.
Other Components
Work in the area of the pressure shut-down facility, or variations in pressure (e.g. as caused by change in level), can affect the accuracy of the device.
Where several infusion lines are connected, the possibility of their exerting a mutual influence on each other cannot be excluded. Cases of possible incompatibility can be found in the directions on use of the medicament or appliances in question.
See also VDE 0753, Part 5, "Application Rules for Parallel Infusion - Possible Application Methods", or the BBM application directives for parallel infusion (38910004).
Only combinations of equipment, accessories, working parts and disposable parts that have been shown to be compatible shall be used.
The use of disposable parts that have not been tested or approved might well exert an influence on the technical data.
Connected analogue and digital components must verifiably satisfy the EN specifications (e.g. EN60950 on data processing devices and EN60601 on medical electrical devices). Anyone who additionally connects devices to the signal input or output part is a system configurator and is thereby responsible for compliance with the systems standard EN60601-1-1.
Safety Standards
Perfusor compact satisfies all safety standards for medical electrical devices in terms of the IEC 601-1 and IEC 601-2 (-24) publications. Note: IEC 601-1 corresponds to the European Standard EN60601.
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Perfusor compact
Contents
Perfusor compact / Overview Page 4 Operation Page 6 Technical Data Page 10 Start-up and Trumpet Curves Page 12 Warranty Page 13 Ordering Page 14
The Perfusor compact is a transportable infusion syringe pump in accordance with EN60601-2-24 (draft), Points 2.2.18 and 2.2.23 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.
3
Overview
Handle
Always use the handle when carrying
Display
Shows all important features at a glance: rate, type of syringe, mains or rechargeable battery, carriage control "Alarms" on page 9).
and alarm symbol (see
Operation
For special functions first press the
Syringe holder
Locks in the syringe. To remove, pull and swing to the left.
The drive unit can be moved by hand after the locking lever has been opened.
Short instructions for use and Syringe Table
See the underside of the device.
F button.
Battery
Press here to change the battery. Interrupt the connection to the patient during changing of the battery. Switch off the device and pull the cover downwards. Always renew all batteries, taking care to observe waste disposal regulations.
4
Multi-Function Connector (MFC)
Connection for staff call; ambulance cars (12V) and interface.
Mains Connection
Connection for the mains supply. In the event of power failure, automatic switch-over to battery.
Input Correction
Interrupt alarm signal for 2 min.
On/Off. Press for 2 sec to switch off.
Start/Stop Infusion
Decimal Point
Inspection on Delivery
Despite careful packaging the risk of transport damage cannot be entirely excluded. Upon delivery please check that nothing is missing. Do not make use of a damaged device! Contact the service department.
For special functions (green) first press
Transport/Carriage
A maximum of three devices can be connected together. Special care is required here if a patient is already connected. Avoid external mechanical influence!
Locking Devices Together
Place one device on top of the other. Push down the connecting part until clicks into place. Lock by turning the vane until it is vertical.
To disconnect, turn until horizontal and then
neu
push upwards.
Stand Clamp/Attachment on Stand
Attach the Perfusor compact from above, clicking it into place. To release, press the black button. For safety purposes attach each device separately to the stand.
Packaging: Reusable, therefore environmentally acceptable (returns will be accepted).
Extent of Delivery: Perfusor compact, power lead, pole clamp, instructions for use, 4 batteries.
F.
5
Operation
1. Insert Syringe
Raise syringe and prime infusion line. Tip: an alternative is to evacuate the air using the bolus button (non-delayed start of infusion).
Switch on using . – Note the automatic check:
- After switching on, all display elements must
appear for approx. 2 sec and the audible
alarm must be heard (see Display, page 4).
- Then comes the rate display:
111.1 222.2 555.5
- Then the software version: AA
In addition the
point blink.
Open the syringe holder, release and pull out the drive unit.
Insert the syringe such that the grip and the pressure plate reach the guide. Lock syringe holder again. If the syringe has been "correctly" placed the release catch will snap back on its own.
(The type-of-syringe number displayed must match that of the syringe inserted - see table.)
Confirm the type of syringe by pressing F .
Connect the patient.
2. Setting the Rate
Value between 0.1 and 99.9 ml/h. Check display. To correct:
Press C and enter the rate anew.
3. Start Infusion
Press START. Running control is displayed.
4. Stop the Infusion
Press STOP or for 2 sec. Disconnect the patient.
Open the syringe holder. Remove the syringe.
To switch off, press for 2 sec .
, CC, and decimal
Here, insert only an Original 50 ml Perfusor Syringe (OPS).
Here, all others.
Syringe grip plate Release
Change of Syringes
Press STOP.
Disconnect the patient!
Remove the syringe. Fit a new air-extracted
syringe with infusion line.
Confirm the type of syringe using button F. (Only necessary when using another syringe type than before.)
Connect the patient and press START.
To Alter the Rate
Press STOP.
Press C and enter the new rate.
Press START.
To Alter the Rate Without Interrupting the Infusion
While the infusion is taking place: simply press
C and enter the new rate, then confirm this
with F. The new rate will now apply. (If
F is not pressed the display reverts to the old
rate after 10 sec).
Syringe pressure plate
6
Special Functions
Activate the special functions using the F button (F is shown in the display). During infusion only the status can be shown; when stopped, changes in value can also be shown. Use the F button to confirm input values or to interrupt the function.
Syringe Selection
Open the syringe holder, press the symbol for syringe selection; the syringe code blinks. Press enter a new number and confirm this using F. After adjustment check the new syringe number once while infusion is taking place by pressing and .
(The bolus rate can be altered by the service unit.) Checking the bolus rate: Press
each individually. Initiating the bolus:
First press F, then - while holding this - press
BOL and keep both pressed. An audible signal
will be given for each ml. Take care not to overdose!
Given a bolus rate of 800 ml/h, e.g. 0.1 ml will be reached in just 0.45 sec.
A pause in the infusion without a reminder alarm signal being sounded. Set values are retained. The display shows
Shows the volume already infused. If this exceeds 999. display. Return the volume to 0,0 ml by pressing C or by switching the device off.
Bolus
F, then press BOL,
Standby
and F.
Infused Volume
9 ml ---,- will be shown on the
Volume Preselection
Infusion stops automatically when the set volume is reached. Display of the preselected
C,
volume: Press first
F
To alter: Press
For 0 ml the volume limitation is switched off. Below 1 ml the volume precision can be reduced. During active volume selection the symbol displayed blinks. Volume preselection is erased when the device is switched off.
Shows the actual Dianet address for control by PC. To change the address:
Press operation: press START.
Shows the remaining capacity of the (rechargeable) battery:
The device switches off in the event of line failure. The switch-off pressure can be set at from P1 (low) to P3 (high). To alter:
Press At the sounding of the pressure alarm the bolus
volume built up by the device (approx. 1 ml at the highest compression phase) is automatically reduced.
F, then Volume Preselection (ml).
C and then enter the desired volume.
CC Operation
C and enter the new address. To start CC
Battery Capacity
low medium high
Occlusion Pressure
F and then select 1, 2 or 3.
7
Mains/Battery Operation
General Information
Check that the mains voltage corresponds to that on the main label! In the event of power failure the device switches automatically to battery operation. Alternatively, a rechargeable battery pack from B. Braun can optionally be used.
To ensure safe and reliable operation certain rules of application must be noted.
The capacity display is a trend display (low,
medium, high).
The actual capacity available can vary from
this due to
- different battery manufacturers
- temperature
- varying load (e.g. frequent bolus input). Batteries can explode or leak causing
damage if they
- are opened or burned,
- are wrongly poled,
- are used such that new and old batteries are placed together,
- used together with a different make of batteries.
Batteries should be removed from the device
during longer period of non-use (storage > 3 months).
The batteries should be renewed when
- a signal such as "battery empty" or "battery pre-alarm" is given
- breakdown or interruption occurs in connection with frequent bolus requirements.
- After a period of use of > 2 years, even if the capacity display indicator shows "full".
The switch-on test checks whether the
internal energy supply is capable of sounding a power-failure alarm. If the energy source is exhausted an alarm acknowledgement is produced. In this case the operator may only use the device under constant supervision, since a power failure would remain undetected by the device.
Only alkali-manganese batteries may be
placed in the battery compartment.
- The alkali-manganese batteries recommended are free of mercury and cadmium.
- Conventional carbon-cell batteries are give an incorrect reading on the capacity display and cannot therefore guarantee reliable operation.
- NiCd rechargeable batteries must not be connected to the battery contact points as their various physical properties disturb the alarm.
NiCd rechargeable batteries are available as an accumulator pack (accessories).
- The accumulator pack is charged by the Perfusor during mains connection.
8
Alarms
CC Operation
Causes of Alarm
Audible alarm: the alarm signal blinks in
cases of alarm.
Battery empty, battery pre-alarm beginning
30 min. before the battery is empty.
Pressure alarm because of an occlusion;
automatic bolus reduction.
Pre-alarm 3 min. before syringe is empty
(only black field is blinking) resp. infusion end.
Reminder alarm if the awaited input has
not been received and pre-alarms
Syringe frame pressure plate has not been
correctly positioned.
+ Pressure alarm, automatic bolus reduction has been interrupted. Bolus has to be reduced manually.
Syringe catch at the drive head has not
clicked into place.
Volume alarm, quantity reached.
Eliminate the cause of alarm and then press the start button. If the alarm sounds again, contact the service unit.
Interrupts the alarm for a period of 2 min.
Interface Operations
Descriptions of interfaces are available from B. Braun.
Connection to the input interface (MFC). Two possibilities are envisaged:
Documentation
All operational data can be called up and recorded via an external PC.
CC Operation
All functions can be specified using an external computer. This must satisfy the IEC 601-1 safety standards and must comply with the conditions of the IEC 513 single-fault safety requirement.
Check Regularly
Check for cleanliness, completeness and damage. Operate in accordance with the Instructions for Use. On switching on, check: the self-check, alarm signal, operating and alarm-control displays. Check battery contacts once a year for corrosion and clean them using a soft rubber.
Hygiene / Waste Disposal
Displays
Special function is active Mains operation Vol. preselection active
+ Service mode of operation; blinks
when the service interval has elapsed. Operation / Running control
Clean using mild soap suds. Do not use spray disinfectant at the mains connection. Recommended: disinfectant for wiping available from B. Braun (e.g. Meliseptol). Before operating the device allow to air for at least 1 min. Do not spray into openings in the device. Be sure to observe the instructions provided on waste disposal and hygiene.
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Technical Data
Type of unit Infusion Syringe Pump Classification
Moisture protection IP 22; drip protected for horizontal usage Rated voltage 230/240 V, 50/60 Hz ~ or
Power input 12 VA / 24 VA External extra-low voltage 12 V d.c. (e.g. ambulance cars) Staff call Max. 24 V / 1 A / 24 VA
RFI EN55011 EMC EN60601-1-2
Time of operation 100 % (continous operation) Operating conditions
- Relative humidity 30 % ... 90 % (without condensation)
- Temperature + 5 °C ... + 40 °C
- Atmospheric pressure 500 mbar ... 1060 mbar
defibrillation proof; CF type
Protection class II
110/120 V, 50/60 Hz ~
Arbitrary connection polarity (VDE 0834)
Storage conditions
- Relative humidity 30 % ... 90 %
- Temperature - 20 °C ... + 55 °C
- Atmospheric pressure 500 mbar ... 1060 mbar Type of battery pack NiCd (rechargeable)
Operating time of rech. battery > 10 h at Recharging time > 16 h Battery 4 x 1.5 V alkali manganese
(Duracell recommended) Operating life of battery > 80 h at Weight/Dimensions (WxHxD) Approx. 1.5 kg; 190 x 100 x 120 mm
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< 10 ml/h
< 10 ml/h
Selectable B. Braun syringes 20 ml Original Perfusor Syringe
Delivery rate 0.1 - 99.9 ml/h (in 0.1 ml/h increments) Bolus rate 800 ml/h Delivery preselection 0.1 - 999.9 ml in 0.1 ml increments Accuracy of set delivery rate typ. ± 2,5 %, (measuring time > 1 h and
Occlusion alarm pressure 3 settings (low, medium, high; max. 1.2 bar)
50 ml Original Perfusor Syringe
50 ml Omnifix LL
50 ml Proinjekt
infusion volume > 2 ml)
Alarm in the event of incorrect dosage a) Malfunctions of the device
Syringe table showing minimum lifting volume required to activate the 3-min prior alarm
For incorrect dosages of > 0.015 ml due to
malfunctions of the device the pump
automatically switches off.
b) At shutdown typ. 1 ml bolus volume at
highest compression phase with 50 ml OPS ^=
max. alarm delay time at 5 ml/h = 6:50 min.
Type Code No. Min. Vol.
OPS 50 ml 50 5,6 ml
Proinjekt 50 ml 51 9,8 ml
Omnifix 50 ml 52 9,2 ml
Euroject 50 ml 61 9,3 ml
B-D Plpak 50/60 ml 61 9,3 ml
Terumo 50/60 ml 54 7,0 ml
Terumo (USA) 60 ml 60 7,3 ml
Monoject (USA) 50/60 ml 62 5,4 ml
Monoject (EU) 50/60 ml 55 9,6 ml
OPS 20 ml 20 5,3 ml
Omnifix 20 ml 22 6,3 ml
Terumo 20 ml 23 4,5 ml
B-D Plpak 20 ml 24 5,3 ml
Monoject (USA) 20 ml 26 6,5 ml
Monoject (EU) 20 ml 29 4,4 ml
^
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Start-up and Trumpet Curves
20 ml OPS
Delivery rate = 1 ml/h
1,5
1
0,5
0 30 60 90 t (min) 120
20 (ml/h) flow
15
10
5
0 30 60 90 t (min) 120
2 (ml/h) flow
1,5
1
0,5
0 30 60 90 t (min) 120 2 5 11 19 pt (min) 31
50 (ml/h) flow
37,5
25
12,5
0 30 60 90 t (min) 120
20 ml OPS
Delivery rate = 10 ml/h
50 ml OPS
Delivery rate = 1 ml/h
50 ml OPS
Delivery rate = 25 ml/h
The graphs show the accuracy/uniformity of flow in relation to time. Allow for the following:
The delivery behaviour or delivery precision is essentially influenced by the types of (disposable) syringe used. Significant deviations may be encountered if use is made of (disposable) syringes other than those stated in the order data.
15% deviation 2 (ml/h) flow
10
5
0
5
10
2 5 11 19 pt (min) 31
15% deviation
10
5
0
5
10
2 5 11 19 pt (min) 31
15% deviation
10
5
0
5
10
15% deviation
10
5
0
5
10
2 5 11 19 pt (min) 31
Trumpet Curves
Measured values for second and last hour in each case.
Measurement interval t = 5 min
Observation interval p ·t (min)
Start-up Curves
Measurement interval t = 5 min
20 ml OPS
Delivery rate = 1 ml/h
20 ml OPS
Delivery rate = 10 ml/h
50 ml OPS
Delivery rate = 1 ml/h
50 ml OPS
Delivery rate = 25 ml/h
Measurement duration T = 120 min
Flow Q
i
(ml/h)
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Responsibility of the Manufacturer
Warranty
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 the IEC publications and
- The device is operated in line with the
instructions for use.
- The regular technical inspections are carried
out.
Warranty
B. Braun provides 24 months warranty, as from the date of delivery, for every Perfusor compact. This covers repair or replacement of parts damaged 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 incl. normal batteries and rechargeable batteries.
The CE mark confirms that this medical product complies with the "Council Directive on Medical Devices 93/42/EEC" dated 14th June 1993.
B. Braun Melsungen AG
Service
A technical inspection must be carried out on
the Perfusor compact every 2 years, with an
entry being made in the medical product book
in accordance with the checklist.
Service work must be carried out exclusively by
personnel instructed by B. Braun.
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Ordering
Copy and send by post or by fax to:
B. Braun Melsungen AG Sparte Medical Postfach 1120 34209 Melsungen
Fax +49-(0) 5661 - 71 - 37 98
Telephone orders:
Tel.: +49-(0)5661-71 - 0
Original Perfusor Syringes
Original Perfusor Syringe 50 ml with draw-off cannula ____0872 8810 Original Perfusor Syringe 50 ml without draw-off cannula ____0872 8844 Original Perfusor Syringe 50 ml with draw-off cannula and particle filter, ____0872 8828 with light protection Original Perfusor Syringe 50 ml with draw-off cannula and particle filter ____0872 8852
Original Perfusor Syringe 20 ml with draw-off cannula ____0872 8623 Original Perfusor Syringe 20 ml without draw-off cannula ____0872 8615 Original Perfusor Syringe 20 ml with draw-off cannula and particle filter ____0872 8631
Original Perfusor Tubing
Original Perfusor tubing N, made of PVC, with Luer lock connectors, 150 cm ____0872 2960 Original Perfusor tubing L, made of PVC, with Luer lock connectors, 200 cm ____0872 2862 Original Perfusor tubing MR, made of PVC, with Luer lock connectors, 75 cm ____0872 2870
Original Perfusor tubing M, made of PVC, with loose lock nut on patient end, 150 cm ____0872 2994
Original Perfusor tubing PE, made of PE, with Luer lock connectors, 150 cm ____0872 2935 Original Perfusor tubing S, made of PVC, light-protected,
with Luer lock connectors, 150 cm ____0872 2919 Original Perfusor tubing PES, made of PE,
light-protected, with Luer lock connectors, pressure-resistant, 150 cm ____0872 3010 Original Perfusor tubing MK, made of PVC,
with cannula, with Luer lock connectors, 75 cm ____0872 2889 Original Perfusor tubing, made of PVC,
with sterile filter 0.22 µ, with Luer lock connectors, 200 cm (not for use together with 20 ml syringes) ____0872 3001
Delivery address:
Qty/Art.no.
14
Perfusor compact (230 / 240 V) ____0871 4827 Perfusor compact (110 / 120 V) ____0871 4835
Recommended accessories for the Perfusor compact
Connecting lead for staff call ____0871 1682 Connecting lead for ambulance car (12 V) ____0871 1674 Interface lead with electrical isolation ____0871 1661
Rechargeable battery pack ____0871 4991 Y-lead for central mains power supply for 2 Perfusors ____0870 0109
Ordered by (name):
Date / Signature:
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Material no. 3891 1108, Drawing no. M659 01 01 01 F04a 4/97 Printed on pulp bleached 100 % chlorine-free
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Sparte Medical B. Braun Melsungen AG Postfach 1120 D-34209 Melsungen
Tel +49-(0) 5661- 71 - 0 Fax +49-(0) 5661- 71- 20 44
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