HF 440 Operators Manual Release 6.00

1.1.6 1.1.7 6

Terminate the treatment ... 44 Patient's blood return ... 44

SAFETY HAZARDS AND PROTECTIVE SYSTEMS ... 45 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 6.13

7

ALARMS INFORMATION ... 45 DETECTION OF AIR ON THE BLOOD RETURN LINE ... 46 ARTERIAL PRESSURE ... 46 VENOUS PRESSURE... 46 TRANSMEMBRANE PRESSURE ALARM ... 46 TRANSFILTER PRESSURE ... 46 BLOOD LEAKS THROUGH THE MEMBRANE ... 46 SINGLE NEEDLE CYCLE... 46 FLUID BALANCE ERROR... 46 POWER FAILURE ... 47 PERIPHERAL ALARMS ... 47 EMERGENCY BLOOD RETURN PROCEDURE ... 47 LIST OF ALARMS: ... 48

TECHNICAL SPECIFICATIONS ... 58 7.1

8

REQUIREMENTS OF THE STANDARD IEC EN 60601-1-2:2001: MANUFACTURER’S DECLARATION ... 61 MISCELLANEOUS ... 65

8.1 8.2 8.3 8.4

SYMBOLS ... 65 CONDITIONS OF USE AND TRANSPORT ... 66 PLACING ORDERS ... 67 DISPOSAL ... 68

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1 Introduction 1.1 Intended Use The intended use of the HF440 is extracorporeal blood purification by convection, diffusion or adsorption including, or not, compensation of the components extracted from blood. Its application range is therefore restricted to: -

hemofiltration,

-

plasma exchange by filtration,

-

hemodialysis,

-

hemodiafiltration,

-

ultrafiltration,

-

double filtration,

-

CPFA (Combined Plasma Filtration Adsorption)

-

hemofiltration.

-

hemoperfusion,

-

plasma perfusion

Note 1 : For all treatments, operator shall base his setting according 

to the patients on-going situation,



the relevant state of art,



the published scientific literature.

Note 2 : For treatments using an adsorption column the priming, rinsing and use must be done according to the specifications and rules made by the manufacturer of the said column. In such case operator must also refer to the column manufacturer's information for the clinical validation and therapeutic use.

1.2 Contraindications The HF440 must not be used in the following cases:  For patients weighing less than 5 kg  For all situations described in the medical literature as presenting a potential or real risk to the patient that would be related to devices containing an extracorporeal blood purification circuit and/or any of the intended use of the HF440

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1.3 Treatment specifications

-

HF HD HDF UF TPE/PEX DF PP HP CPFA

Continuous / Intermittent

HF

A

S/D

C/I

0-400

12

HF

P

D

C/I

0-100

0-1.5

HP

A

S/D

C

0-250

HP

P

D

C

0-100

HDF

A

D

C/I

0-400

0-7

0-12

HDF

P

D

C/I

0-100

0-2

0-4

HD

A

D

C/I

0-400

TPE / PEX

A

S/D

I

0-250

0-4.5

TPE / PEX

P

D

I

0-100

0-1.5

DF

A

S/D

I

0-250

0-4.5

DF

P

D

I

0-100

0-1.8

CPFA

A

D

C

0-250

0-4.5

PP

A

D

C

0-250

0-4.5

Filtrate [l/h]

Dialysate flow [l/h]

/ Single Double needle

Parameters flow

Options

Blood flow [ml/min]

Treatment

Adult / Pediatric

The specifications of the treatments are represented in the following table

0-12

UF : 6

: Hemofiltration, : Hemodialysis, : Hemodiafiltration, : Convective flow through membrane, : Therapeutic plasma exchange, : Double filtration, : Plasma perfusion, : Hemoperfusion. : Coupled plasma filtration adsorption

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1.4 Principles of extracorporeal purification The principle of the flow controls in the HF440, is based on the extracorporeal circulation of blood and the automatic assessment of the exchanged masses through their weights on scales. The extracorporeal blood circulation is achieved through a peristaltic pump. Arterial and venous pressures as well as the presence of possible air bubbles are permanently monitored during the treatment. The waste fluid is removed by a pump from the filter. It contains filtrate (ultrafiltrate or plasma) removed from blood by convection, and in HD/HDF treatments the used dialysate. A scale measures its total mass. The substitution fluid is pumped from bags or bottles. Its flow is adapted to maintain the patient's weight variation to the value defined by the operator. The proportion, or ratio, of fluid supplied in pre and post dilution or dialysate is defined by the operator. A hematocrit variation sensor is available as an option to help the operators to control the effect of the patient’s weight variations. WARNING : The patient’s fluid balance shall be controlled during treatment by the operators in such a way to prevent both hypotension due to fluid removal and oedema due to an accumulation of fluids. The fluid heater helps maintaining the patients temperature within the requested range by warming up the substitution fluid. This is of particular importance when fluid is cold (i.e. fresh frozen plasma), the flow is high (i.e. high volume hemofiltration) or the clinical situation does request it. The syringe pump is available to be used for anticoagulation according to an established medical protocol.

With the 40 kg scales option of the HF440 : 1. it is recommended that not fewer than 3 bags are placed at once, 2. pediatric treatments are not possible

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1.5 Treatments operation The different treatments operate in different ways and may request different disposable elements such as filters or tubing sets. In the following paragraph key differences between the treatments setting are explained.

1.6 Hemofiltration and ultrafiltration

The hemofilter size used has to been in proportion with the flows. Infomed provides 4 sizes ranging from 0.3 sqm for pediatric application to 1.9 sqm for high flow hemofiltration. The substitution fluids are pharmaceutical products manufactured for hemofiltration treatments. The tubing set provides pre and post-dilution injection. When used for ultrafiltration the priming is the same as in hemofiltration but in treatment the substitution pumps are stopped.

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1.7 Hemodiafiltration and hemodialysis

The hemofilter size used has to been in proportion with the flows. Infomed provides 4 sizes ranging from 0.3 sqm for pediatric application to 1.9 sqm for high flow hemodiafiltration or hemodialysis. The use of a hemodialyser is not advisable as it may provide leaks and overpressures thus creating potential injuries. The substitution fluids are pharmaceutical products manufactured for hemodiafiltration treatments. In case of pure hemodialysis, dialysate bearing CE mark may be used. The tubing set provides possibilities to operate with dialysate and either pre-dilution or post-dilution injection. It is important that the tubing set assembly corresponds to the medical protocol requested.

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1.8 Plasma exchange

In plasma exchange a plasmafilter must be used. Infomed provides 2 membrane sizes, the 0.3 sqm for pediatric and treatments with blood access in peripheral vein and 0.5 sqm for blood access by catheter or fistula. The substitution fluids are pharmaceutical solutions of colloid type (i.e. HES, albumin solution, fresh frozen plasma). The tubing set incorporates a predilution line that is used only for priming. Treatment is always performed in pure postdilution.

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1.9 CPFA CPFA is a treatment which combines adsorption on plasma and hemofiltration. WARNING : Particular attention must be paid : 1/ not to swap plasmafilter and hemofilter which could lead to patient plasma losses 2/ connect the sorbent inlet/outlet to the right connectors to avoid injection of sorbent molecules within the patient

The plasmafilter LF-050 inlet is right after the blood pump, its outlet right before the hemofilter inlet, and the plasma port is to be connected to the upper right pump. The hemofilter DF-140, inlet is right after the plasmafilter outlet, its outlet is connected to the venous bubble trap, and ultrafltrate port is to be connected to the yellow pump. The sorbent (SO-310 in case of sepsis) receives plasma from the top where it is connected with the red connector to the bubble trap. It must be placed in the right flow direction (on SO-310 an arrow indicates the requested flow direction) in order to avoid loss of sorbent within the patient. The substitution fluids are pharmaceutical products validated for hemofiltration treatments. The tubing set provides the plasma loop and hemofiltration with replacement in postdilution injection. To be noted that for each elements there is a paper holding the connectors on which the name of the element is written such as : “LF plasmafilter”, "DF Hemofilter", “sorbent”.

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1.10 Double filtration In double filtration plasma is first extracted from the blood and then passed through a second filter, named plasma fractionator, which retains the larger molecules while allowing the smaller ones to return to the patient's blood.

The efficiency of the treatment relies on the fact that the plasma fractionator membrane remains in optimal working conditions. A rinsing by flush of the filter based on the TMP allow to reach this goal. It runs by first stopping automatically the plasma pump, opening the clamp on the waste line and closing the one on the plasma line. Then the rinsing pump is activated at a flow and for a volume defined by the operator and the fresh fluid pushes the larger molecules which have previously accumulated within the plasma fractionator. When the rinsing volume is reached the rinsing pump is stopped and the treatment continues. The plasmafilter is placed on the blood circulation. The plasma is circulated through the plasma fractionator which is selected depending on patient's pathology and molecules to be removed from blood. Clearance of the different molecules to be cleared (i.e. LDL-cholesterol) or to be returned (i.e. albumine) must be carefully evaluated at the time of choice of this filter. The rinsing fluid must be a pharmaceutical product validated for injection into patients. Normal saline is the most commonly used. The tubing set is specific for double filtration. To be noted that for both filters there is a paper holding the connectors on which the name of the filter is written such as : “LF plasmafilter” or "fractionator".

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1.11 Hemoperfusion The sorbent is of any type available on the market and must be used for the field of application described by the sorbent manufacturer. It must be placed in the right flow direction and if necessary followed by extra filters protecting the patient in case of leakage of the sorbent material from the cartridge. The substitution fluids are pharmaceutical products valid for injection to patients. They are used only for the priming. The tubing set have injection lines integrated that are used only for the priming.

1.12 Plasma perfusion

The filter may be a plasmafilter or an albumine filter depending on the treatment and sorbent requests. The sorbent is of any type available on the market and must be used for the field of application described by the sorbent manufacturer. It must be placed in the right flow direction and if necessary followed by extra filters protecting the patient in case of leakage of the sorbent material from the cartridge. The substitution fluids are pharmaceutical products valid for injection to patients. They are used only for the priming. The tubing set are provide with sorbent bypass lines that are used only for the priming.

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2 Introduction to the equipment HF440 device : Front view

Visual alarm Touch screen PF pressure PC pressure Blood pump PU pressure Waste/UF pump Plasma clamp Lower blood leak detector (BLD) Waste clamp

Model label Arterial pressure Venous pressure Upper right pump Lower right pump Air detector Venous clamp 5th pump Substitution scale

Waste scale Central scale

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HF440 device : Rear view

Syringe pump

Rear door

Main label's position

Communication port (under the machine)

Main switch Machine base Front wheels with brake

Rear wheels

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HF440 device : Right view

Left view

PBC pressure

PPL pressure Upper blood leak detector (BLD)

Filter(s) support(s)

Substitution fluid heater

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2.1 Fluid heater Intended use : the fluid heater can be used to warm up the substitution fluid and/or the dialysate which will be circulated in the heater bag placed in contact with the heating element. WARNING : The fluid heater is not intended for direct blood warming. Therefore blood must not be circulated within the heater bag. During priming and rinsing the status "Heater ON" indicates that the heater is heating at its default temperature (38oC) while the status "Heater OFF" indicates that for some technical reason the heater is cannot be powered on. During treatment the heater temperature can be set between 30oC and 40oC by step of 0.1 degree.

2.2 5th pump and central scale (optional) The 5th pump must be connected to a bag placed on the central scale. During treatment the 5th pump is either driven in accordance with the blood pump (flow set as a ratio to blood) or as an independent substitution pump (flow set in ml/h). In the first case the 5th pump will run whenever the blood pump runs while in the second case it will run only when the lower right substitution pump runs. In both case the flow is calculated using the third scale.

2.3 Syringe pump Intended use : the syringe pump is intended to be used for anti-coagulation. WARNING : For safety reasons the syringe driver must not be used for any medication other than those described in the intended use. Specifications for usable syringes 1. Classical form 2. With luer-lock connection 3. With rubber seals 4. Size : from 10 to 60 ml During treatment the syringe pump flow is driven in accordance with the blood pump and will thus be stopped only if the blood flow is stopped.

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2.4 Hematocrit variation sensor (optional) The hematocrit variation sensor shows a value proportional to the quantity of light being reflected by the blood. Therefore, the more the blood is diluted, the more light will be reflected and the signal will increase. On the other hand with more red cells per unit of blood the signal reflected will decline and therefore the displayed signal will decrease. In a usual setting which includes a patient’s weight loss, the value would be stable at the beginning of treatment, reflecting that the blood is refilled by the cells, and then decreasing showing that the refill is becoming more slow than the speed of water removal by the treatment. A strong increase may indicate that the weight loss requested shall be either reduced or stopped.

2.5 Extended range - ECMO (optional) The Extended range - ECMO system operates as follows: To access the extended range area: Press the pressures button then the extended range button Each A and V sensors have 1 positive and negative connector with a range up to 500 mmHg (Minus 500 if negative). During priming, connections are the usual ones. During treatment on the pressure window there is an extra button which is named ECMO Mode. Activating this mode allows the software to open the limits of A/V pressures between -500/+500 mmHg. A/V pressure connectors must then be selected depending on the connection of the machine to the extracorporeal blood circulation and the pressure ranges set accordingly. When ECMO Mode is used the automatic blood flow is de-activated.

ECMO Option

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In addition to the machine, the following items are required to perform a treatment: Filters: The filters has to be selected according to the medical protocol to be applied to the patient's clinical situation. To prevent risks of disconnection and leakage all ports should be equipped with luer-lock connectors. Infomed supplies 4 types of hemofilters (with membrane sizes of 0.3, 0.8, 1.4, 1.9 sqm) and 2 types of plasmafilters (with membrane sizes of 0.3 and 0.5 sqm) Sorbents : For any treatment using a sorbent the operator must ensure that the following manufacturer parameters are fully respected : - Rinsing volume prior t treatment - Protection is set against maximum trans-cartridge pressure - Maximum flow is set to protect the cartridge against overflows - 2 filters are placed in series between the sorbent and the venous bubble trap to prevent the injection of sorbent to the patient. WARNING : The HF440 is not equipped to perform automatic regeneration of columns. Tubing set: Depending on the type of treatment, different tubing sets are available. See chapter 13.5 for references. Using tubing sets other than those provided by Infomed may result in patient's injury. In such case the operator would involve his own liability. Substitution fluid: This has to be chosen by the person in charge of the treatment and adapted to the type of treatment and to the patient's clinical status. Bags should not contain more than 5 liters of fluid and must preferably be equipped with a female luer-lock connection. Waste container: 5 litres bags, sterile or not, with luer-lock connectors, 1 to 4 (standard version) or 1 to 8 (40 kg option). For the use of rigid containers please refer to your local representative.

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3 Before using the device 3.1 Installation The installation of the HF440 shall be exclusively performed by a technician agreed by the distributor who will also be in charge of the periodic servicing. It is mandatory that the following rules are strictly followed by the operators: Place of use

Dry room with no water seepage, all conditions inside the environment of use being within limits described in chapter 13

Positioning

Close to the patient (< 1 meter), protected from direct sunlight

Access

Easy access to the front part of the machine is necessary

Moving the machine

Disable the front wheel brakes. Push or pull the machine by holding it by the enclosure. Never pull the filter or the tubing to move the machine. When at the right place, lock the two front wheel brakes.

Maintenance

Maintenance shall be carried out by a technician agreed by the manufacturer. It shall be requested by the operator in any case where the safety of the device may be questioned.

Protective earth

The mains plug to which the machine is connected MUST be equipped with an earth pin which once the machine is connected allows compliance with electro-medical devices applicable requirements.

Manufacturer maintains technical documentation available for technicians.

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3.2 Warnings The blood purification device HF440 has been designed to be used in a medical environment by qualified staff whose training has been defined and controlled by the care unit's responsible person. This document addresses people familiar with extracorporeal blood purification techniques. Anyone supposed to use the HF440 must read this manual carefully and observe all its indications as well as those placed in the related disposable sets boxes. The manufacturer and the distributor decline all responsibility for any misuse by unstained personnel or by any person who has not observed the rules of the present document. Any default of this device shall be reported to the distributor or the manufacturer. When the default has, or might, cause a major damage, or death, the hospital must immediately inform the distributor or the manufacturer. The distributor can supply ad hoc default reporting forms. Using substitution fluids made for the intended use will not lead to a safety hazard if reverse ultrafiltration (backfiltration) occurs. Blood losses may lead to a dangerous situation when running high flux (> 6 l/h) therapies for 12 hours or more. In such case, manual check for blood losses is necessary. Operator must conform to alarm messages when alarms occur. Operator must survey both machine and patient as long as override modes are activated. Safety may be compromised if the machine is exposed to an electromagnetic field with power or frequency out of IEC 601-1-2 requirements. The syringe pump is intended to be used only for anticoagulation purpose. The communication port must never be connected while treatment is running unless agreed upon in writing by Infomed. Running the HF440 pumps may lead to EKG artefacts. Thus at the start of treatment operator shall observe the cardiac monitoring to see if it is affected by the running HF440.

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3.3 Rules for use It is vital that operators respect all the following rules:  Never shake the machine during the treatment and never deposit "clandestine" weights such as scissors, notebooks, etc on the scales.  Ensure that the device is installed conforming to the present manual's rules and according to the state-of-the-art and regulations valid for the electro-medical devices.  Make sure that only manufacturer's agreed-by disposable sets are used, follow the indications placed inside their boxes and make sure connections are correct. The use of a non agreed disposable, without prior and written consent of the manufacturer, is under the full responsibility of the medical center.  To avoid cross infection, a new tubing set must be used for each new patient or treatment.  Check that substitution and rinsing fluids are adapted to the patient and therapy and comply with all applicable regulations.  Check that each data shown on the screen corresponds to the expected result.  Never authorise a trans-membrane pressure limit that is above the maximum specified by the manufacturer of the filter in use.  Without delay inform the agreed technical staff for every detected default that might endanger the patient's health.  Interrupt the treatment and disconnect the patient if his health may be endangered by the pursuing of the treatment.  Close the pumps before starting the machine and do not open them before the end of the treatment. Don’t change the lines or filter connections after the rinsing.  Replace the disposable (filter and tubing) before each treatment and when machine requests to do so. To avoid cross-infection replaces all disposable items each time a different patient is connected to the machine.  Make sure that all sterile items and their bags are free of any damage before opening them.  Never touch patient and machine simultaneously.  Never connect non medical devices  If any filter protecting the pressure sensors is made wet by any liquid, remove this by using a syringe. In case the protective filter is, or might be, broken place an additional filter on the first one.

In all cases, the operator shall observe their patient and make sure, as often as necessary, that the treatment continues correctly and safely.

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