HF 440 Technical Manual Feb 2008

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1 Products presentation For the introduction to the products use please refer to the HF400/HF440 users manual which describes in particular the intended uses and the possible options. The HF400 was introduced on the market in 1999 while the HF440 was introduced in 2003. The main elements are the same, they differ only by the scales mechanic and the enclosure-foot, as well as the fluid heater. Moreover on HF440 only, the CPFA option can be used as well as the 5th pump and third scale. The present manual covers the technical aspects for all uses and options which can be present or not on the machine on which the work must be done.

2 Warning The HF400/HF440 device must be maintained and repaired only by persons who are formally authorised to do so by Infomed. This is the case when the technical staff has followed the courses provided by Infomed and received a certificate validating the acquired knowledge. All technicians must carefully read the present manual and follow all it’s indications. The same applies for the users manual. Infomed will not be responsible for any work done by non agreed persons or by persons who don’t respect the procedures described in the present manual. All defects can be submitted to the distributor or manufacturer using the technical report form placed in annex of the present document. In the cases that have, might have, caused a major injury or death to at least one patient, the distributor or the manufacturer must be informed without delay.

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3 Infomed parts exchange and support policy

In case of technical problems, Infomed may require to receive the technical report form completed present in annexe of the present manual before further analysis. To help identifying problems, Infomed may request machines logfiles before proceeding further. Any parts returned to Infomed shall be sent with the technical report form, present in annexe of the present manual, completed. Packing shall be done in such a way not to damage further the parts. Parts that are under warranty can be sent back to Infomed for repair. Parts that are not covered by warranty can either be send to Infomed for further diagnostic or thrown away according to local regulation. The following parts can be returned by Infomed for repair :

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BC400, CM400, MP400, CU160, Pump heads, Scales assembly, Plate heater.

In case repair is possible, Infomed will charge the time spent and the new parts to be changed. All other machine parts will be exchanged against new ones.

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4 Identifying models and options Models : Machines have a front sticker identifying the model HF400 or HF440. An immediate identification of the models can also be done looking at the lower parts of the machines were the scales are located, as shown on the following picture.

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Machines have a backwards sticker identifying the serial number, date of manufacturing, and manufacturer, plus some extra indications and symbols.

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Options : Depending on the different options included in the machines, some parts are present or not. The figure below shows this :

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5 Identifying parts Since the first machines, besides some minor mechanical and cabling changes, some parts have been exchanged and or modified. The different types that can be found and the way to identify them are described hereafter. BC400 : There are 3 types of PC that have been used and which may have slightly different behaviours in terms of screen brightness, memory of logfiles and reactivity. These differences are handled by Infomed and for the field technicians the different BC400 are to be handled in the same way. CM400 : There are 3 types CM400. The original one was produced until 2000 and then replaced by the second one with following additional features

1 more pressure sensor (5 instead of 4) 1 port for heparin pump 1 connector for the cascade/CPFA clamps

Both boards can easily be differentiated on their upper part by the presence or not of the heparin pump connector.

Heparin pump connector

First version

Second version

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The third CM400 board was routed in 2007 and has the following differences with the second edition : 1/ The board is powered by 30 VDC only and generates 5, 12, 24 VDC for all elements of the machine. 2/ The motor control is now for stepper motors instead of brushless DC 3/ The buzzer has been replaced by a loud-speaker 4/ Space is proposed to hold the CU-160 board 5/ Pressure sensors are positioned i the lower part of the board 6/ 24 VDC battery, instead of 7.2 V allows to rotate blood pump during power failure 7/ A potentiometer is present to adjust the BLD value

5, 12, 24 VDC supply

Loud speaker

Stepper motors connector

CU-160 connector

BLD potentiometer

Battery connector and loader

Pressure sensors

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Scales electronic : There are 2 possible types of electronic for the scales. The first type is dedicated to the scales and has been replaced in 2005 by a multi-purpose board the MP400 which was routed again in 2006. The pictures below show the 3 systems :

A/D converter D6 board

D6 board with the A/D converter connected to the sensors (2 per system) The scales calibration with a D6 is done directly on the D6 with a special set of buttons. It cannot be done through the machine’s technical window. Between the first and second MP400 there are mostly the following differences :

The heater sensor connector was changed The PIC programming connector was changed The heater door switch connections were modified requesting a new switch cable

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PIC programming connector MP400 first generation

MP400 second generation

Heater sensors connectors Scales sensors direct connectors Power supplies : There are 4 possible types of power supplies which appear on the picture below.

AL-124-01

AL-125-01

AL-126-10

AL-124-01 type was used between 1999 and 2005, AL-125-01 in 2005-2006, type AL126-10 in 2006-2007 and from the revision 3 of the CM400 board AL-130-00.

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The 3 first power supplies provide 5, 12, 24 VDC while the last one provides 30 VDC only. For EMC on the 230 VAC we shall find a filter before the AL-124-01, a ferrite before the AL-125-01 and nothing before the AL-126-10 and AL-130-00.

GND

30 VDC

Bridges

Bridge

90-240 VAC input

earth

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Main switch : There are 2 types of main switch depending if the remote control of the power supply is used or not. In one case the main power passes through the switch while in the second case there is only a signal that drives the power supply remote control.

Different connections and acceptable currents

Switch for remote control

Switch on main

To be noted that the remote control has been used on the AL-124-01 and AL-125-01 models only. The switch on main can be used on all models. Warning : If the switch for remote control is present, don’t use it to connect directly the main as it would warm up and burn due to an unacceptable power.

Heparin pump : 2 types of syringe driver may be found, the first one being replaced in 2003 by the second. The figure below shows their different look.

First type

Second type

Regarding the use and calibration both heparin pumps are identical.

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Pump heads : 3 different types of pump heads can be found. The original plastic ones were then replaced by the first metallic model which was modified in 2006 to the second model. The figure below shows the 2 metallic types.

Different lower parts Fluid warmers : 4 different types of fluid warmers can be found on the HF400/HF440 machines. Coil heaters are of 2 types, screwed on the front face, delivered until 2005. Plate heaters are also of 2 types, placed on the machine’s right side. The one for HF400 is a heating plate receiving an exchange tube while the one for HF440 is a heating plate receiving a dedicated disposable bag covered by a door.

Coil heater on HF400/HF440 front face. Position is between the venous clamp and the BLD

Spare part changes for HF440 from S/N 0249-007 CM-400-02 MP-400-02 None None AL-126-10 AL-126-00 AE-807-03 None None CA-122-31

Electronic board & power supply Motherboard with heparine pump and cascade CM-400-03 Motherboard with heparine pump and cascade controls controls (step motors) MP400 Multi IO board MP-400-03 MP400 Multi IO board CU-160-12 CF electronic board (for 5th pump) CA-007-31 CM400 to CU160 cable Power supply 4 VDC outputs (5, 12, 24V) Power supply (output 30V) AL-130-30 Assembly plate & power supply (5, 12, 24V) AL-127-00 Assembly plate & power supply 30V NiCd Accu Pack 7.2V 600mA with contact

Power supply cable (Power supply to CM400/MP400)

AL-500-00 AE-810-02 CA-030-41 CA-090-31

Battery assembly (with cables) HF battery batteries cables Power supply cable (Power supply to CM400/MP400)

GM-450-00 GM-452-00 GM-410-00

Motors and assembly Brushless motor with gearbox 65/2 GM-500-00 Step motor for pump Brushless motor with gearbox 338/5 GM-500-00 Step motor for pump + GM-420-16, Coupling shaft for blood pump GM-610-00 Coupling shaft assembly for blood pump & Stage for blood pump with overunning clutch

GM-411-01 HF-415-00

Coupling shaft for exchange pumps Complete motor assembly (plate + 4 motors)

None CA-025-51 CA-031-51 CA-042-51 None None

None BL-818-00 None BL-140-00 None BL-818-01 BL-840-01 BL-122-00 BL-102-01

Short motor cable Medium motor cable Long motor cable

Complete 18 kg sensors assembly

Coupling shaft assembly for exchange pump Motor assembly for HF (4 motors for front face with only 6 inserts)

CP-720-01 CA-028-11 None CA-040-12 CA-028-12 CA-040-13

Incermental sensor complete assembly Short motor cable

Weight system BL-706-10 BL-720-00 BL-720-10

Complete assembly of scale sensors 40kg 18kg sensor 40kg sensor U-bearing for 2 18kg scale sensors U-bearing for 2 40kg scale sensors

GM-610-10 GM-570-10

BL-740-00 BL-706-01 BL-720-01 BL-740-01 BL-128-01 BL-128-01

Long motor cable Short motor counter cable Long motor counter cable

2x6kg weigth system for 3rd weight system Complete tight 20 kg sensor assembly Complete large 20 kg sensor assembly (only available in case of 3rd weight system) Complete 40 kg sensor assembly 6kg sensor (for 3rd weight system) 20kg sensor 40kg sensor U-bearing for 2 scale sensors U-bearing for 2 scale sensors

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HF400/HF440 Technical Manual Chapter 01 : Assembling / disassembling parts Table of Content 1 2

Assemblies... 2 Sub-assemblies ... 2 2.1 Air detector ... 2 2.2 BC400 ... 2 2.3 Blood leak detector : ... 3 2.4 Venous clamp ... 3 2.5 Cascade / CPFA clamps... 4 2.6 CM400 and battery ... 4 2.7 CU-160 ... 8 2.8 Filter support :... 9 2.9 Fluid heater : ... 9 2.10 Hematocrit sensor : ... 9 2.11 Main switch : ... 10 2.12 Motor plate : ... 10 2.13 MP400 : ... 11 2.14 Power supply : ... 12 2.15 Pump heads :... 12 2.16 Internal pressure tubes : ... 13 2.17 Scale sensors :... 14 2.18 Heparin pump ... 16 2.19 Visual alarm :... 17 2.20 Front face ... 18 2.20.1 Coil heater assembly:... 19 2.20.2 Assembling the bubble trap support: ... 19 2.20.3 Assembling the pressure connectors:... 19 2.21 Lower and upper rear doors ... 20

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1 Assemblies The HF400 and HF440 machines are made of the electro-mechanical modules described in the present chapter. The references given here are those of the model produced from year 2007. For machines produced before this period please refer to the original technical manual. To simplify the update of the present manual, the text contains almost only reference to the detailed drawings.

2 Sub-assemblies 2.1 Air detector See CP-110-00, drawing AA dated 11/07/2006 Assembling procedure 1. From the front face, pass the cables of the detector through its support and the aluminium plate. 2. Screw the detector with the 2 screws and washers.

2.2 BC400 The BC400 is to be considered as a closed box. In case of problem field technicians shall return it to Infomed for diagnostic and repair. Assembling procedure 1. Make sure that the seal is present, properly glued and without hole 2. Make sure that the 4 spacers are glued around the 4 screws 3. Place the BC400 inside the machine 4. Place the 2 grounding cables and the related spacers 5. Screw the BC400 nuts

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BC400 control box Seal to be glued inside enclosure

4 x nut

4 x washer glued inside the enclosure

2.3 Blood leak detector : See CP-500-00, drawing AA dated 11/07/2006 Note : the blood leak detector does exist with 2 length of wire. The longer one is for the CPFA option when placed on the side of the HF440 and connected to the MP400. The blood leak detector placed on the front face is connected to the CM400. If CPFA option is installed a second detector is placed on the upper left side of the machine and connected to the MP400. These 2 blood leak detectors are exactly identical. To install each BLD proceed as follows : Assembling procedure 1. Screw the main part on the front or side face 2. Place the interface on the blood detector circuit 3. Screw this on the blood detector electronic with 2 screws 4. Connect the interface to its electronic board

2.4 Venous clamp See HC-410-00, drawing AA dated 10/07/2006 Assembling procedure 1. Insert the clamp finger in the clamp’s enclosure. 2. Screw the clamp’s enclosure with 4 screws.

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3. Assemble, if not in place, the 4 Spacers on their screws. 4. Place the electromagnet on the 4 Spacers with 4 nuts.

2.5 Cascade / CPFA clamps See HC-455-00, drawing AA dated 10/07/2006 There is 1 clamp used for CPFA priming and 2 clamps for cascade. When power is off these clamps are closed by a spring. They are present only if the CPFA or cascade options have been placed on the machine. Note 1 : If CPFA option is present without double filtration only 1 clamp is present on the machine. Note 2 : The rear nut reference 7 on the drawing is either not present or there are 2 of them, one blocking the other. Assembling procedure 1. Insert the clamp finger in the clamp’s enclosure. 2. Screw the clamp’s enclosure with 4 screws. 3. Assemble, if not in place, the 6 Spacers on its screws. 4. Place the electromagnet on the 6 Spacers with 6 nuts.

2.6 CM400 and battery On HF400 : See CM-415-00, drawing AA dated 06/01/2000 On HF440 : For models equipped with CM400 release 2, see CM-410-00, drawing AA dated 31/05/2006. For those equipped with CM400 release 3 see CM-410-01, drawing OFI CM-410-01 dated on 20.02.2008 and AL-500-00, drawing AA dated 12.06.2007, mod 1. Assembling procedure Assembling the CM400 board on the metallic plate: 1. If it is not present, place and fix the air detector board on the CM400. 2. Place the CM400 on 8 Spacers, the power supply connector being on the lower part where the battery is. 3. Fix the board with 8 screws. Assembling the CM400 plate in the machine: 1. Place the whole metallic plate in position 2. Place the grounding cables 3. Fix the plate on the left of the machine with screws (HF400) or nuts (HF440) Changing the battery for CM400 release 2 : 1. Remove the present battery by cutting the 2 straps. 2. Place a new battery with 2 new straps. 3. Connect the new battery

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Important warning : Due to possible short-circuits, the battery shall be placed on a plastic film, not directly on the metallic plate, and on its side as shown on the following pictures.

Correct installation of the battery

Wrong installation of the battery

Changing the battery for CM400 release 3 : 1. Disconnect the battery from the CM400 2. Remove the 2 nuts and the holder 3. Replace the battery, holder and nuts 4. Connect the battery to the CM400 For battery assembly see drawing AL-500-00, drawing AA dated 12.06.2007, mod 1.

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Connecting the CM400 board See chapter 02 and below picture for connectors definition

CM-400-02 board connections

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