Fresenius Kabi APPLIX SMART User manual

TECHNICAL MANUAL
ENG
APPLIX Smart
Enteral Feeding Pump
En
t
era
l
Fee
d
ing Pump

Revisions table
TM APPLIX SMART INT ref TM 1722
Valid for pumps whose serial number is from 17670295 till...
Date Revision Chapter Description
Dec. 17th, 2014 6Index "g"
- Spelling corrections.
- Update of electrical characteristics,
conformity to standard, maintenance (only
recycling §), storage (only recommended
temperatures), "useful addresses"
chapters.
- The sentence "Carry out complete
control of the device (Refer to Quality
Control Certificate)" was added at the end
of the intervention procedures.
Sept. 3rd, 2015 7Index "h"
Oct. 14th, 2016 8Index "i"
- Precautions to be taken for flow rate test
were added.
- Update of the "Introduction", the
"Electrical" , "Conformity to standards"
sections.
- "Essential performances" and
"Recommended cleaning agents" (in
"Cleaning and desinfecting" section)
sections are added.
- Some warnings are added in the
introduction of "Intervention procedures".
Electrical safety test is added in section
4.3.20. and in the Quality Control
Certificate.

Applix_Smart_int_TDM.fm 3
1 Introduction ...................................................................................................... 5
1.1 Operation diagram ................................................................................. 5
1.2 Precautions for use................................................................................ 6
1.3 Safety features........................................................................................ 6
1.4 Technical data ........................................................................................ 6
1.4.1 Electrical..................................................................................................................... 6
1.4.2 Mechanical .................................................................................................................6
1.4.3 Conformity to standards ............................................................................................. 6
1.4.4 Material characteristics .............................................................................................. 7
1.4.5 Essential performances.............................................................................................. 7
2 Description and operation............................................................................... 9
2.1 Physical description of the pump......................................................... 9
2.1.1 The pump ...................................................................................................................9
2.1.2 The holder ................................................................................................................ 13
2.2 Functional description......................................................................... 15
2.2.1 Subassembly of holding and control of giving set .................................................... 15
2.2.2 Pumping subassembly ............................................................................................. 15
2.2.3 Holder subassembly with external connections ....................................................... 15
3 Calibration menu ............................................................................................ 17
4 Preventive maintenance ................................................................................ 19
4.1 Recommendations ............................................................................... 19
4.2 Maintenance.......................................................................................... 19
4.3 Checks................................................................................................... 21
4.3.1 Access to calibration menu (CAL)............................................................................ 21
4.3.2 Battery temperature ................................................................................................. 22
4.3.3 Battery voltage ......................................................................................................... 23
4.3.4 Mains presence or not.............................................................................................. 23
4.3.5 Buzzer test ............................................................................................................... 24
4.3.6 Door position ............................................................................................................ 24
4.3.7 Optical clamp detection............................................................................................ 24
4.3.8 Optical background signal........................................................................................ 25
4.3.9 Keyboard.................................................................................................................. 25
4.3.10 LCD .......................................................................................................................... 26
4.3.11 Nurse call relay ........................................................................................................ 26
4.3.12 Air detection .............................................................................................................26
4.3.13 Motor command test ................................................................................................ 27
4.3.14 Door alarm test......................................................................................................... 27
4.3.15 Optical detection alarm test...................................................................................... 27
4.3.16 Downstream occlusion alarm test ............................................................................ 28
4.3.17 Upstream occlusion alarm test................................................................................. 28
4.3.18 Air detection alarm test ............................................................................................ 29
4.3.19 Pump + holder test................................................................................................... 29

44Applix_Smart_int_TDM.fm
4.3.20 Electrical safety test ................................................................................................. 29
4.3.21 Quality Control Certificate ........................................................................................ 31
4.4 Flow rate control .................................................................................. 33
4.4.1 Measurement with scale .......................................................................................... 33
4.4.2 Measurement using a test tube ................................................................................ 35
4.5 Cleaning and desinfecting .................................................................. 37
4.6 Storage.................................................................................................. 38
5 Diagnosis.........................................................................................................39
5.1 Troubleshooting................................................................................... 39
5.2 Error messages.................................................................................... 41
6 Intervention procedures.................................................................................45
N°1, Procedure: Housing ........................................................................... 47
N°2, Procedure: Rechargeable battery ..................................................... 51
N°3, Procedure: Board ............................................................................... 53
N°4, Procedure: Pumping unit................................................................... 55
N°5, Procedure: Membrane........................................................................ 57
N°6, Procedure: Gearbox/motor ................................................................ 59
7 Spare parts catalogue ....................................................................................61

applix01_01h_int.fm 5
Introduction
1 Introduction
The APPLIX Smart is intended exclusively for enteral feeding.
The APPLIX Smart pump is a peristaltic pump delivering enteral nutrition and hydration to the
patient through a feeding tube.
It can be used with both home patients and hospital patients.
The pump is a very simple pump to operate which has a continous feeding administration
programme and several functions for patient safety.
1.1 Operation diagram

6applix01_01h_int.fm
Introduction
1.2 Precautions for use
The manufacturer may in no case be held responsible for any medical or any other problem,
resulting from a mis-use of the equipment.
Consult the Instructions For Use for further information.
Temperature: +13°C to +40°C.
Humidity: 10% to 85% non condensing.
Atmospheric pressure: 700 hPa to 1060 hPa.
1.3 Safety features
The device has a continuous function inspection system as soon as it is switched ON. Any
internal failure or any problem in the operating procedure is detected immediately.
Nevertheless, abnormal operation of the equipment with no obvious cause must always be
reported to the qualified person in your plant or our After Sales Service.
The Applix pump is equipped with an internal battery which will supply power for normal
operation if there is an electrical disturbance in the mains network.
1.4 Technical data
1.4.1 Electrical
Mains supply: 100-230 VAC (acceptable variation 85% / 110 %) - 50-60 Hz/15 VA.
Pump holder output: 7.75 VDC, 800 mA.
Pump battery mode: 24 h at 125 ml/h.
Battery type: NiMH 4.8 V, 1.2 Ah-1.8 Ah.
Nurse call:
potential-free switch, 4 KV decoupling.
power output: 24 V/ 100 mA to power nurse call.
1.4.2 Mechanical
Pump:
Dimensions H x W x D: 128 x 114 x 43 mm.
Weight: 480 g.
Holder:
Dimensions H x W x D: 146 x 162 x 115 mm.
Weight: 450 g.
1.4.3 Conformity to standards
Complies with Medical Device Directive 93/42 EEC CE mark : CE 0123
EN/IEC 60 601-1-1.
EN/IEC 60 601-2-24 E.M.C.
EN/IEC 60 601-1-4 risk analysis.
Protection against electric shock: Protection class II, symbol ; type BF, symbol .

applix01_01h_int.fm 7
Introduction
Protection against moisture:
Pump: IP 34 (splash-protected).
Holder: IP 31 (drip-protected).

Detailed information concerning electromagnetic compatibility is available in the
"Guidance and manufacturer’s declaration" section of the Applix pump Instructions For
Use.
1.4.4 Material characteristics
For the pump
Components Materials
1Keyboard Polyesters
2Door Polycarbonate
3Counter door Polyamide 30% GF
4Handle Polyamide 30% GF
5Door hook overmoulded Polyacetal
6Top surface with
optical guide
Polycarbonate/ABS
Polycarbonate
7Front surface plug Polypropylen
8Sector handle door Polyamide
9Clamp Polyacetal
10 Pump pusher Polyacetal
11 Overmoulded membrane TPE + Polypropylen
12 Pumping body Polyamide 30% GF
13 Optical disk Polyacetal
14 Special gear box parts Polyacetal
15 Pulley Polyacetal
16 Gear box silent bloc Rubber
For the pump holder
Components Materials
1Pump housing Polycarbonate/ABS
2Upper housing holder Polycarbonate/ABS
3Lower housing holder Polycarbonate/ABS
4Hook holder Polyamide 30% GF
5Cap hook holder Polyamide 30% GF
6Connector housing holder Polycarbonate/ABS
7Pole clamp holder PA + aromatic
1.4.5 Essential performances
Applix Smart essential performances are defined as follows in standard operating
conditions:
Flow rate accuracy: +/-10% at 300 mL/h, with medical water.
Downstream occlusion time: less than 2 min. at 150 mL/h, with medical water at 21°C.
Bolus after downstream occlusion release: less than 5 mL.

8applix01_01h_int.fm
Introduction

applix02_01g_int.fm 9
Description and operation
2 Description and operation
2.1 Physical description of the pump
Housing Top surface
Door lever
Keyboard
Holder
Pump door
The APPLIX Smart is composed of a pump which can be mounted on a holder.
2.1.1 The pump
The APPLIX Smart is composed of a top surface unit holding the mechanical and electronic
assembly. A housing fastened on the top surface unit performs mechanical protection and
waterproofness of the pump.

10 applix02_01g_int.fm
Description and operation
The housing is holding:
A keyboard.
Five contacts to connect the pump to the holder.
The housing is connected to the different parts by means of connectors and contacts.
54321
Contacts holder/pump
1
10
to CPU board
Keyboard connector
to CPU board
Keyboard connector to CPU board
Pin Description
1ON/OFF
2Column 5
3Column 4
4Column 3
5Column 2
6Column 1
7Line 3
8Line 2
9Line 1
10 ON/OFF
Contacts holder/pump to CPU board
Pin Description
1GND
2Alarm command ouput (nurse call)
3Output Txd
4Input Rxd
5Power supply

applix02_01g_int.fm 11
Description and operation
The top surface unit is composed of:
A CPU board.
A pumping unit.
A top surface.
The CPU board
The CPU board is holding the power and command electronics for the pump and the LCD
screen required for man/machine interface.
1 5
1 6 1 5
2 1
1 4
1 10
J21
J4
J16
J5
J6
J17
Keyboard
Optical
detection Motor
Battery
Air detection Holder
CPU board
It is connected to the different parts by means of connectors.
Connector J4 to keyboard
Pin Description
1ON/OFF
2Column 5
3Column 4
4Column 3
5Column 2
6Column 1
7Line 3
8Line 2
9Line 1
10 ON/OFF

Connector J5 to battery
Pin Description
1Battery (0 V)
2CTN GND
3CTN (+)
4+ V Bat
Connector J6 to holder contacts
Pin Description
1GND
2Alarm command ouput (nurse call)
3Output (Txd)
4Input (Rxd)
5Power supply
Connector J16 to motor
Pin Description
1Motor -
2Motor +
Connector J17 to air detection
Pin Description
1Transmitter (+) anode
2Transmitter (-) cathode
3GND
4GND
5Receiver (+) anode
6Receiver (-) cathode
Connector J21 to optical board clamp
Pin Description
1GND
2 N.U.
3OUT 2 (Clamp)
4INPUT
5Power supply (V_FCY)
12 applix02_01g_int.fm
Description and operation
The pumping unit
The pumping unit is fastened on the top surface. It is composed of a frame holding the
pumping mechanism, the motor driving system, the electronic board and the battery.
The top surface
The top surface is the interface between the internal and external parts of the pump.
With the door it allows the giving set to be held in the right position.

applix02_01g_int.fm 13
Description and operation
2.1.2 The holder
The holder is composed of a housing equipped with a clamp used to fasten it on a pole.
The holder includes a supply board which supplies 7.75 VDC mains to the APPLIX pump. It
also performs the loading of the battery included in the pump.
It is also equipped with:
An RJ45 plug for connection of the nurse call relay output or the connection to a PC
(RS232).
Five contacts for its connection to the pump:
Pin Description
1GND
12345
Front view of contacts
2Alarm command ouput (nurse call)
3Output Txd
4Input Rxd
5Power supply
Connection of the nurse call alarm output
The nurse call alarm output can be connected by mean of a cable equipped with an RJ45
plug.
Characteristics:
Plug: 8-pin male RJ45.
Length of cable: 2.5 m.
Cable: ref. MJ8 P8C SUNS-PUlow vlt computer.
External connection: 3 tinned wires.
Connection
Pin Description
1
Link with PC
18
678
2
3
4
5
6Relay normally open, colour of cable: orange
7Common point, colour of cable: yellow
8Relay normally closed, colour of cable: brown RJ45 male plug
:
Note:
Ref. 7751761
You can purchase this cable from our Technical Service
(Refer to the Useful addresses section in this document).


14 applix02_01g_int.fm
Description and operation
RS232 connection
Characteristics:
Plug: 8-pin male RJ45.
Length of cable: 2.5 m.
Cable: ref. MJ8 P8C SUNS-PUlow vlt computer.
External connection: DB9 female.
Connection
Pin RJ45 DB9 female
13 TxD
1
8
27 RTS
34 DTR
42 RxD
55 GND
6
7
8Plug male RJ45.
:
Note:
Ref. 200991
You can purchase this cable from our Technical 
Service (Refer to the Useful addresses section 
in this document).

applix02_01g_int.fm 15
Description and operation
2.2 Functional description
The APPLIX pump is composed of three functional subassemblies:
A subassembly of holding and control of giving set.
A pumping subassembly.
A holder subassembly with external connections.
2.2.1 Subassembly of holding and control of giving set
The giving set is installed on the top surface and maintained in position by the door.
The top surface is equipped with three detection systems:
A sensor to control the closed door position (CPU board).
An optical sensor to detect the type of the installed giving set (optical board).
An ultrasonic sensor to detect air bubbles presence in the giving set (CPU board).
2.2.2 Pumping subassembly
The pumping subassembly includes the peristaltic mechanism of pumping.
This mechanism is composed of a camshaft performing the alternative travel a 1 pumping
finger and 2 clamping fingers. The travel of these pushers, managed by the CPU board,
performs the liquid displacement at the flow-rate.
A DC motor with a gear-box subassembly drives in rotation the camshaft by means of an
indexed belt.
An optical disc fastened at the camshaft end performs the rotation control.
The occlusion detection is carried out by the measurement of motor current.
2.2.3 Holder subassembly with external connections
The presence of the pump on the holder is detected by a sensor mounted on the holder and
associated to a magnet fastened inside the pump.
The holder is equipped with a RJ45 connector used for nurse call alarm or communication
with a PC.

16 applix02_01g_int.fm
Description and operation

applix03_01g_int.fm 17
Calibration menu
3 Calibration menu
The calibration menu is used to perform tests and consult the different values of the pump.
The modification of these parameters can only be performed from a PC equipped with the
APPLIX control software. The software can be ordered by approved and qualified
technicians who have been trained.


For access to the different parameters readout, refer to "Control" section.
The calibration menu gives access to twenty-one sub-menus. Only twelve are necessary for
the maintenance technician. Others are not detailed in this document.
49, not detailed.
50, battery temperature.
51, battery voltage.
52, not detailed.
53, not detailed.
54, not detailed.
97, mains presence or not.
98, buzzer.
100, door position detection.
101, optical clamp detection.
102, not detailed.
103, optical background signal.
107, keypad.
108, LCD.
110, nurse call relay.
112, not detailed.
113, not detailed.
114, air detection.
118, not detailed.
119, motor command test.
122, not detailed.

18 applix03_01g_int.fm
Calibration menu

applix04.1&2_01g_int.fm 19
Preventive maintenance
4 Preventive maintenance
4.1 Recommendations
The APPLIX pump can only be inspected, maintained or repaired by an approved and
qualified service. Any abnormal operation of the equipment must be signaled to the qualified
maintenance person in your plant or to our After Sales Service.
If a repair is necessary, send the pump (in its original packaging if possible) with a precise
description of the observed fault, to the official service department.
Please call our Technical Service or our Customer Service for any information about the
repair and use of the device.
The manufacturer cannot be held responsible if the equipment is lost or damaged during
transport to our Technical Service.
4.2 Maintenance
Periodicity Designation
12 months Carry out a periodical control.
2 years Replace the battery (refer to “battery” intervention procedure).
We recommend the following maintenance intervals:

Recycling of obsolete batteries and devices:
Before disposal, remove battery from the device. Batteries and devices with
this label must not be disposed of with the general waste. They must be
collected separately and disposed of according to local regulations.
For further information pertaining to waste processing regulation, contact your 
local Fresenius Kabi organisation or the local distributor.

20 applix04.1&2_01g_int.fm
Preventive maintenance