HF 440 Technical Manual Aug 2009

Technical manual

Technical Manual Chapter 00 : Introduction to products family

Table of Content 1

PRODUCTS PRESENTATION ... 2

2

WARNING ... 2

3

INFOMED PARTS EXCHANGE AND SUPPORT POLICY ... 3

4

IDENTIFYING MODELS ... 4

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1 Products presentation For the introduction to the products use please refer to the HF440 users manual which describes in particular the intended uses and the possible options. HF440 was introduced on the European market in 2004. The present manual is written for machines produced from 2009. For machines produced until end of 2008 please refer to original technical manuals. The elements that may differ between different models are the scales mechanic and the enclosure-foot, as well as the fluid heater. Moreover some HF440 are equipped with a new option, 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 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 Models : The standard HF440 is delivered with the following features: " 4 pumps " Heater " Syringe driver And performs the following treatments: " CVVH " CVVHDF " TPE " HP Machines have a main label identifying the serial number, date of manufacturing, and manufacturer, plus some extra indications and symbols described in the users manual.

Model 220V

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Model 110V

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Options : HF440 machine can have different options. This can be identified by checking the presence of these components as per the below photos.

" Double filtration

" CPFA

" Citratmodule

" Single needle

" Hematocrit sensor

" ECMO blood access

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Technical Manual Chapter 01 : Assembling / disassembling parts Table of Content 1! Introduction ... 2! 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! CPFA clamp ... 4! 2.6! CM400... 4! 2.7! CU-160 ... 7! 2.8! Battery pack... 8! 2.9! Fluid heater :... 8! 2.10! Hematocrit sensor... 8! 2.11! Main switch :... 9! 2.12! Motor plate : ... 9! 2.13! MP400 : ... 10! 2.14! Power supply :... 11! 2.15! Pump heads : ... 13! 2.16! Scale sensors : ... 13! 2.17! Heparin pump... 15! 2.18! Visual alarm : ... 16! 2.18.1! Assembling the pressure connectors: ... 17! 2.19! Lower and upper rear doors ... 17! 3! Changing processor boards ... 17! 3.1! BC400... 17! 3.2! Changing the MP400... 18! 3.3! Changing the CM400 ... 19! 3.4! Changing the CU160... 19!

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1 Introduction The 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 2009. For machines produced before this period please refer to the original technical manual. To simplify the update of the present manual, the text contains references to detailed drawings.

2 Sub-assemblies 2.1 Air detector 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

TBD changer image

2.3 Blood leak detector : Note : the blood leak detector does exist with 2 length of wire. The longer one is for the upper blood leak detector used for CPFA and connected to the MP400. The lower blood leak detector is connected to the CM400 The 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 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 4 Spacers on their screws. 4. Place the electromagnet on the 4 Spacers with 4 nuts.

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2.5 CPFA clamp There is 1 clamp used for CPFA priming. When power is off this clamp is closed by a spring. 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 4 Spacers on its screws. 4. Place the electromagnet on the 4 Spacers with 4 nuts.

2.6 CM400 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 4 nuts Connecting the CM400 board See chapter 02 for connectors definition

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5, 12, 24 VDC supply

Loud speaker

Stepper motors connector

CU-160 connector

BLD potentiometer

Battery connector and loader

Pressure sensors

Battery loader voltage adjustment

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CM-400-03 board connections

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2.7 CU-160 The CU-160 is simply screwed on the 6 spacers placed therefore on the CM400. On HF440 CU-160 is used only for the 5th motor and third scale and is thus not present if this option is not on the machine. Connections are as shown below.

Motor connector

CM400 communication

Power IN

Lower scale sensor

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Upper scale sensor

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2.8 Battery pack Changing the battery : 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

2.9 Fluid heater : Complete : see RE-100-01, drawing AA dated 06/06/2006, mod 1. Plate : see RE-120-01, drawing AA dated 06/06/2006, mod 2. Door : see RE-130-01, drawing AA dated 14/12/2006, mod 1. Note : The plate fluid heater is powered by the MP400 directly with 115 or 230 VAC. To be noted that the working voltage (115 or 230 VAC) shall be indicated at the time of order as the heating element (2 models, 1 for 115 and 1 for 230 VAC) and fuses shall be adjusted. The plate heater shall be sent back complete to Infomed in case it needs to be repaired. WARNING : Heater calibration is a critical safety parameter and it is important key that the heater temperature is never higher than 41o C . For control and calibration please see chapter 05. Assembling procedure on HF440 Fixing the plate 1. Pass the cables through the machine enclosure holes. 2. Screw the plate from inside the machine Fixing the door 1. Remove one of the RE-106-01 part 2. Place the door 3. Screw the RE-106-01 Fixing the switch 1. Screw the switch support from inside the machine 2. Screw the switch on it’s support 3. Adjust the switch position according to chapter 05

2.10 Hematocrit sensor see CP-210-00, drawing AA dated 12/07/2006, mod 1. HF440 TECMAN CH01.DOC

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Assembling procedure 1. Pass the sensor cable through the front face 2. Place the sensor inside it’s plastic support EX-101-01 3. Screw the 4 screws from inside the machine

2.11 Main switch :

Nut to be placed from inside the machine

Assembling procedure 1. Pass the switch cables through the hole 2. Screw the nut from inside taking care of the position of the I/O plate 3. Place the LED and all external element as shown on the above picture.

2.12 Motor plate : Assembling procedure 1. Make sure that the pump heads are all removed 2. Place the complete motor on the rubber spacers, the blood pump motor being in the upper right corner. 3. Fix the plate with the nuts.

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2.13 MP400 : Assembling procedure Assembling the MP400 board on the metallic plate: 1. Place the MP400 on 4 Spacers, the scale sensors connectors being on the lower part. 2. Fix the board with 4 screws. Assembling the MP400 plate in the machine: 4. Place the whole metallic plate in position 5. Place the grounding cables (if any) 6. Fix the plate in the machine with screws (HF440) or nuts (HF440)

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MP400 connections :

2.14 Power supply : On HF440 : For CM400 release 3 see AL-127-00, drawing OFI dated 20/02/2008. WARNING : To fix the power supply it is very important to place the 2 washers per screw. Otherwise the screw may touch the power supply electronic board and create short-cuts that will alter the functioning of the machine.

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Assembling procedure Assembling the power supply on the metallic plate: 1. Place the power supply on the plate. 2. Fix the power supply with 4 screws after placing 2 washers per screw. Assembling the power supply plate in the machine: 1. Place the whole metallic plate in position 2. Place the grounding cables (if any) 3. Fix the plate in the machine with screws (HF440) or nuts (HF440) GND

30 VDC

Bridges

Bridge

90-240 VAC input

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2.15 Pump heads : Pump heads shall be installed as on the figure below :

Assembling procedure 1. Screw the pump head support on the machine front face 2. Screw the pump head body on the support 3. Insert the rotor inside the body 4. Screw the front face taking care of placing the right colour Note : in case of default, the rotors and/or the pump body can be returned to Infomed for

2.16 Scale sensors : WARNING : When screwing any scale sensor make sure that the mechanical effort is not passing through the sensor as this would damage it.

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This is OK Effort is only in the reinforced parts

This will destroy the sensor ! Screwing effort shall not pass through the sensing part Assembling procedure 1. Screw the substitution support from inside the machine 2. For the waste sensor, remove the lower plate of the HF440 then 3. Screw the its upper plate on the sensor 4. Screw this assembly on the lower plate 5. Screw the lower plate to the HF440

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