B Braun Infusomat P User manual

Infusomat® P

Instructions for Use

Software IFPE / IFPe

Patient Safety

Attention: Consult accompanying documents!

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

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.

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

Connected electrical equipment must comply with the relevant IEC/EN-specifications

(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® P 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-magnetic 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.

Infusomat® P

Contents

Infusomat® P / 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® P is a volumetric infusion pump for application of liquids in infusion and nutritional therapy.

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

For further details please refer to the Instructions for Use.

3

Overview

Handle

For easy transport.

Display

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

Keypad for Input

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”

Operating Indicator

Additional operating control indicator in display.

Holder for Drop Chamber		Adapter for Drop Sensor
Prevents unintended		Replaceable, depending on drop
movement (swaying).		chamber size. Press lateral and pull
		off.

Universal Pole Clamp

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

4

Guide for Short Infusion Pole

Mains/Power Connection

(protect against ingress of moisture). In case of mains/power failure, the pump switches to battery operation. Battery operation time:

> 3.0 h at highest delivery rate. Automatic overload protection. Mains fuse: directly above the mains/power connector.

Potential Equalisation

To be connected for CF-applications.

Mains/Power Supply

For operation with fluid manager system.

Door Opener

Aluminium Housing

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

Special Functions "SF”

Function Keys (Soft keys)

Mains/Power Switch ON/OFF

Suppress alarm tone for 2 min

Infusion START/STOP

Multi-Function- Connector (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 (Free flow clamp)

Opening door clamps off infusion line automatically.

Peristaltic Pump

For precise and reliable dosage.

Function Keys

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 / loudness / contrast / date, time.

5

Operation

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. Switch On with

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

Displayed type of infusion line must be identical to the used infusion line. Confirm with “YES”. IFPE: Change of type infusion line is possible if function is activated via Service. Only in this case “NEXT” appears for selection of the type of infusion line.

4.Insert Infusion Line

Press door opener.

Insert infusion line: First locate in free flow clamp, then insert vertical to bottom and fit properly into the air sensor.

Keep infusion line in place at air sensor.Close door.

Open roller clamp completely. There may not be a continuous drip.

Place drop sensor on drop chamber (if necessary, use an appropriate adapter).

5.Puncture

6.Setting the Delivery Rate

In the range: 0.1 - 999.9 ml/h (IFPe in the range: 0.1 - 600.0 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 9).

free flow clamp

air sensor

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 after pressing free flow clamp. - Replacement: Insert new infusion line as described. Then press START again.

To end switch off

Press for 2 sec.

6