Operators Manual
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HF440 Operators Manual
1227 Geneva / Switzerland Tel : + 41 22 827 62 20 Fax : +41 22 827 62 29 Email : [email protected] www.infomed.biz
0123 Ref. MU.401.14 Valid from release 7.00
Table of content 1
INTRODUCTION ... 4 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12
2
INTENDED USE ... 4 CONTRAINDICATIONS ... 4 TREATMENT SPECIFICATIONS ... 5 PRINCIPLES OF EXTRACORPOREAL PURIFICATION ... 6 TREATMENTS OPERATION ... 7 HEMOFILTRATION AND ULTRAFILTRATION ... 7 HEMODIAFILTRATION AND HEMODIALYSIS ... 8 PLASMA EXCHANGE ... 9 CPFA ... 10 DOUBLE FILTRATION ... 11 HEMOPERFUSION... 12 PLASMA PERFUSION ... 12
INTRODUCTION TO THE EQUIPMENT ... 13 2.1 2.2 2.3 2.4 2.5 2.6
3
FLUID HEATER ... 17 5TH PUMP AND CENTRAL SCALE (OPTIONAL) ... 18 SYRINGE PUMP ... 18 HEMATOCRIT VARIATION SENSOR (OPTIONAL) ... 19 EXTENDED PRESSURE RANGE (OPTIONAL)... 19 SINGLE NEEDLE (OPTIONAL) ... 20 BEFORE USING THE DEVICE ... 21
3.1 3.2 3.3 3.4 3.5 4
INSTALLATION ... 21 WARNINGS ... 22 RULES FOR USE ... 23 CLEANING AND SERVICING TO BE PERFORMED BY THE OPERATOR ... 24 TECHNICAL MAINTENANCE AND PERIODIC CONTROLS ... 24 STARTING THE MACHINE ... 25
4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 5
PROCESS FLOWCHART ... 25 SCREEN ORGANISATION ... 26 VALIDATION AND CANCEL KEYS ... 27 ENTERING DATA ... 27 NUMERIC KEYPAD ... 27 THE ALPHANUMERIC KEYPAD ... 28 GENERAL PARAMETERS... 28 DEFINING REFERENCE TREATMENTS ... 28 REFERENCE TREATMENT PARAMETERS ... 30 CHOOSING THE TREATMENT ... 32 PREPARING THE FLUID CIRCUIT ... 33 INSTALLING THE PRE-ASSEMBLED TUBING SET AND FILTERS ... 33 INSTALLING THE HEATER BAG ... 35 INSTALLING THE 5TH PUMP TUBE ... 36 INSTALLING THE SYRINGE ... 37 PRIMING VOLUMES OF USUAL ELEMENTS ... 39 PRIMING / RINSING ... 40
RUNNING A TREATMENT ... 41 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8
TREATMENT WINDOW ... 41 BLOOD CONTROL... 41 EXCHANGE CONTROL ... 42 FLUID BALANCE CONTROL ... 42 TIME RELATED CONTROLS ... 42 FUNCTION BUTTONS ... 43 CONNECTING THE PATIENT... 45 ROUTINE OPERATIONS DURING TREATMENT ... 45 1.1.1 Controlling patient's temperature ... 45 1.1.2 Controlling patient's fluid balance... 46 1.1.3 Pressure controls ... 46 1.1.4 Changing fluid bags ... 46
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1.1.5 Solving alarms... 47 1.1.6 Terminate the treatment ... 47 1.1.7 Patient's blood return... 47 1.1.8 Disconnecting the patient... 47 6
SAFETY HAZARDS AND PROTECTIVE SYSTEMS ... 48 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 ... 48 DETECTION OF AIR ON THE BLOOD RETURN LINE ... 49 ARTERIAL PRESSURE ... 49 VENOUS PRESSURE ... 49 TRANSMEMBRANE PRESSURE (TMP) ALARM ... 49 TRANSFILTER PRESSURE... 49 BLOOD LEAKS THROUGH THE MEMBRANE... 49 SINGLE NEEDLE CYCLE ... 50 FLUID BALANCE ERROR ... 50 POWER FAILURE ... 50 PERIPHERAL ALARMS ... 50 EMERGENCY BLOOD RETURN PROCEDURE ... 51 LIST OF ALARMS:... 52
TECHNICAL SPECIFICATIONS ... 64 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8
8
GENERAL... 64 PRESSURE SENSORS ... 65 OTHER SENSORS ... 66 PUMPS ... 66 HEATER ... 67 OPERATOR INTERFACE ... 67 OTHER ... 67 REQUIREMENTS OF THE STANDARD IEC EN 60601-1-2:2001: MANUFACTURER’S DECLARATION ... 68 MISCELLANEOUS ... 72
8.1 8.2 8.3 8.4
SYMBOLS ... 72 CONDITIONS OF USE, TRANSPORT AND STORAGE ... 73 PLACING ORDERS ... 74 DISPOSAL ... 76
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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)
-
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 TPE/PEX DF PP HP CPFA
Continuous (C) Intermittent (I)
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
0-12
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
0-1.5
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 (S) / (D) Double needle
Parameters flow
Options
Blood flow [ml/min]
Treatment
Adult (A) / Pediatric (P)
The specifications of the treatments are represented in the following table
0-12
UF : 6
: Hemofiltration, : Hemodialysis, : Hemodiafiltration, : 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 (DF serie) 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. PA and PV pressures represent the venous access resistance to the blood flow. PF and PU pressure are used to calculate the filter pressure drop and the transmmebrane pressure. Pressures are described with more details in chapter 7.
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1.7 Hemodiafiltration and hemodialysis
The hemofilter (DF serie) 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 over-pressures 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 or pre-dilution together with 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 (LF serie) 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 an indication on 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 (LF serie) 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. HF440 MU ENG.doc / 2010-12-07
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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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Additionally to the machine, following elements 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 serie 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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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. The actual temperature of the fluid coming out of the heater is often lower than the specified value. Output temperature depends on subsitution flow, inlet temperature of the fluid and heater setting. Below is the example of outlet temperatures at different flows and setting for an inlet temperature of 22 degrees.
The actual outlet fluid temperature is displayed on the heater interface of the machine during the treatment.
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2.2 5th pump and central scale (optional) The 5th pump must be connected to a bag placed on the central scale before starting the rinsing so that the machine will fill the tube and check the scale during the priming procedure. If there isn’t a weight > 400 grams on the central scale at the start of rinsing, the machine considers that the 5th pump will not be used for the treatment. It is then not possible to have the 5th pump running. 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 central scale. For the treatments of hemofiltration, hemodialysis, hemodiafiltration, ultrafiltration, therapeutic plasma exchange and CPFA, the 5th pump susbstitution flow is added to the filtrate flow and thus increases the overall patient clearance. For the treatments of double filtration, plasma perfusion and hemoperfusion, the 5th pump susbstitution flow becomes a weight gain to the patient.
2.3 Syringe pump Intended use : the syringe pump is intended to be used for anti-coagulation. WARNING : For safety reasons the syringe pump 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 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 pressure range (optional) The extended pressure range system allows the connection of the HF440 to extracorporeal blood circuits such as ECMo or cardio-pulmonary bypass. It operates as follows: 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 EXTENDED PRESSURES. Activating this one 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 the extended pressure mode is used the automatic blood flow is desactivated.
Extended pressure range
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2.6 Single needle (optional) The single needle système runs with alternated blood pump (arterial cycle) and venous return (venous cycle) cycles. An expansion volume allows to cumulate the blood during the arterial cycle. A single needle treatment can be set by pressing the corresponding button in the treatment definition window. The possibility also does exist to pass during a double needle treatment to a single needle one. This is done by pressing on the single needle button of the pressure window and following the procedure described on the screen. In both cases an expansion chamber must be installed as follows : Expansion chamber to be installed, Expansion chamber placed on the HF440. here in its sterile packaging One end is connected to the filter outlet, the other one to the venous line.
The tube, placed on top of the expansion chamber and equipped with a pressure transducer allows to adjust the level of blood in the chamber. Besides during this adjustment the clamp on the tube must always be closed. When passing to single mode while there is blood in the lines, it is recommended to return most of the patient’s blood before installing the expansion chamber.
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