Users Manual
45 Pages
Preview
Page 1
Table of contents 1
WARNING ... 4 1.1
2
CONTRAINDICATIONS... 4 INTRODUCTION ... 5
2.1 INTENDED USE ... 5 2.2 TREATMENT SPECIFICATIONS ... 6 2.3 COMPONENTS... 7 2.4 PRINCIPLES OF OPERATION ... 8 3
CONDITIONS OF USE ... 10 3.1 3.2 3.3 3.4 3.5 3.6
4
INSTALLATION ... 10 MANDATORY CONTROLS BEFORE USE ... 10 RULES FOR USE ... 11 CONTROLLING PATIENT'S TEMPERATURE ... 12 CLEANING AND SERVICING TO BE PERFORMED BY THE USER... 12 PERIODIC CONTROLS ... 12 SAFETY FEATURES ... 13
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 5
DETECTION OF AIR ON THE BLOOD RETURN LINE ... 14 ARTERIAL PRESSURE ... 14 VENOUS PRESSURE... 14 TRANSMEMBRANE PRESSURE ALARM ... 14 TRANSFILTER PRESSURE ... 14 BLOOD LEAKS THROUGH THE MEMBRANE ... 14 SINGLE NEEDLE CYCLE... 14 FLUID BALANCE ERROR... 15 POWER FAILURE ... 15 REPLACING THE SUBSTITUTION FLUID... 15 REPLACING THE WASTE CONTAINER ... 15 PERIPHERAL ALARMS ... 15 MANUAL BLOOD RETURN PROCEDURE ... 15 LIST OF ALARMS: ... 16
DISPLAY AND DATA CAPTURE ... 25 5.1 5.2
6
DATA DISPLAY ... 25 ACCESSING THE WINDOWS ... 27 ENTERING / MODIFYING VALUES ... 28
6.1 ENTERING DATA... 28 6.1.1 NUMERIC KEYPAD... 28 6.1.2 THE ALPHANUMERIC KEYPAD ... 28 7
DEFINING THE REFERENCES ... 29 7.1 7.2
8
OPTIONS... 29 REFERENCE TREATMENTS ... 30 STARTING THE MACHINE ... 31
8.1 THE POWER-ON TESTS ... 31 8.2 CHOOSING THE TREATMENT ... 32 8.3 PREPARING THE FLUID CIRCUIT ... 32 8.3.1 OBJECTIVE ... 32 8.3.2 ASSEMBLING THE TUBING ... 32 8.3.3 PRIMING / RINSING ... 34 8.3.4 PARTICULARITIES OF CPFA ... 34 8.3.5 PARTICULARITIES OF 5TH PUMP AND THIRD SCALE ... 35 9
RUNNING A TREATMENT ... 36 9.1 9.2 9.3
10
SETTING THE PRESSURE LIMITS ... 37 TERMINATE THE TREATMENT ... 37 PATIENT'S BLOOD RETURN ... 37 HEATER ... 38
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10.1 PLATE HEATER ... 38 10.2 INSTALLING THE DISPOSABLE ... 38 10.3 COIL HEATER ... 38 10.3.1 INSTALLING THE TUBING SET ... 39 11
HEMATOCRIT SENSOR (OPTIONAL) ... 39
12
HEPARIN PUMP ... 39 12.1 12.2 12.3 12.4
13
DEFINING A SYRINGE ... 40 HEPARIN PUMP USER INTERFACE... 41 PREPARING A SYRINGE ... 41 ALARMS ... 41
MISCELLANEOUS ... 42 13.1 13.2 13.3 13.4 13.5
SYMBOLS ... 42 TECHNICAL SPECIFICATIONS ... 43 CONDITIONS OF USE AND TRANSPORT ... 43 PLACING ORDERS ... 44 DISPOSAL ... 45
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1 Warning The blood purification device HF400/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 HF400/HF440 must read this manual carefully and observe all its indications, particularly those indicated in chapters 3 and 4 and the indications placed in the tubing 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 heparin pump must be used only for anti-coagulants based on heparin. For the devices with the CASCADE options please read the corresponding supplements to the present manual. The communication port must never be connected while treatment is running unless agreed upon in writing by Infomed.
1.1 Contraindications The HF400/HF440 must not be used in the following cases: For patients weighing less than 5 kg. For all situations related to devices -
containing an extra corporeal blood circuit,
-
having any of the intended use of the HF400/HF440 (see chapter 2.1),
described in the medical literature as presenting a potential risk to the patient.
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2 Introduction 2.1 Intended Use The intended use of the HF400/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,
-
hemodialysis,
-
hemodiafiltration,
-
hemoperfusion,
-
plasma exchange by filtration,
-
ultrafiltration,
-
cascade (double filtration) and plasma perfusion in option. In this case the operator must refer to the complementary manual.
-
CPFA for patients undergoing severe sepsis or septic shock. In CPFA, the plasma adsorption of both pro and anti-inflammatory mediators is done in line a standard hemofiltration.
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.
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2.2 Treatment specifications The specifications of the treatments are represented in the following table
-
HF HD HDF UF TPE DF PP HP CPFA
Blood flow [ml/min]
Filtrate flow [l/h]
HF
A
S/D
C/I
0, 30-450
12
HF
P
D
C/I
0, 10-100
0-1.5
HP
A
S/D
C
0, 30-250
HP
P
D
C
0, 10-100
HDF
A
D
C/I
0, 30-450
HD
A
D
C/I
0, 30-450
TPE
A
S/D
I
0, 30-250
0-4.5
TPE
P
D
I
0, 10-100
0-1.5
DF
A
S/D
I
0, 30-250
0-4.5
DF
P
D
I
0, 10-100
0-1.8
CPFA
A
D
C
0, 30-250
0-4.5
PP
A
D
C
0, 30-250
0-4.5
0-7
Dialysate flow [l/h]
Continuous / Intermittent
Parameters
Single / Double needle
Options Adult / Paediatric
Treatment
0-12 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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2.3 Components The device is made of the following elements: 20 1 16 17 22 2 18 12 3 24 9
23
13 14 4 19 6 5 7 21
8 10
11 15
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22.
Touch screen Blood pump Extraction pump Predilution pump Substitution pump Drip chamber (support) Air detector Venous clamp Blood leak detector (BLD) Substitution scale Waste scale Filter(s) support(s) Visual alarm Enclosure Wheels Arterial pressure sensor Prefilter pressure sensor TMP sensor Venous pressure sensor Heparine pump Heater (option) BLD for CPFA cartridge 23. CPFA pressure sensors
24. CPFA clamp Note : On the HF440, the machine is placed on a steel trolley and the scales are the 2 vertical bars, yellow for waste and blue for substitution fluids. Additionally, following elements are required to perform a treatment: Filter: Type to be chosen by the user responsible for the treatment according to the patient's clinical status and to the treatment's type. Tubing: Depending on the type of treatment, different tubing sets are available. See chapter 13.5 for references. 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 be equipped with a female luer-lock connection. Waste container: On HF400 : a rigid plastic can with a volume of 5 to 10 liters, preferably equipped with a handle. Maximum dimensions: height: 30 cm, width: 28 cm, depth: 25 cm or waste bags. On HF440 : 5 litres bags, sterile or not, with luer-lock connectors, 1 to 3 (standard version) or 1 to 8 (40 kg option).
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2.4 Principles of operation The principle of the flow controls in the HF400/HF440, is based on the extracorporeal circulation of blood and the automatic measurement of the masses exchanged through their weights on scales. The extracorporeal 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 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 to the value defined by the user. The proportion, or ratio, of fluid supplied in pre and post dilution or dialysate is defined by the user. WARNING : The patient’s fluid balance shall be controlled by the operators in such a way to prevent both hypotension due to the treatment (fluid removal) and oedema due to an accumulation of fluids. A hematocrit variation sensor is available as an option to help the operators to control the effect of the patient’s weight variations. For single needle the predilution pump becomes a blood return pump. Therefore if single needle hemofiltration is performed it can be done only in postdilution. For CPFA, the predilution pump becomes a plasma pump.
Note : The HF400 and HF440 have exactly the same functioning, however on the HF440 up to 8 bags of 5 liters can be placed at once on each scale. With the 40 kg option of the HF440 : 1. it is recommended that not fewer than 3 bags are placed at once, 2. paediatric treatments are not possible
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Example CPFA principle The CPFA treatment combines a plasma adsorption loop with a standard hemofiltration loop. Both filters are on the same blood line.
Filtration
Restitution
Waste
Adsorption
In CPFA, - The blood first flows through a plasmafilter, then through a hemofilter. - The plasma removed from the plasmafilter is pumped through the sorbent and then returned to the blood circuit between both filters. - The hemofilter is used to perform postdilution hemofiltration thus allowing fluid balances control as well as small and medium size molecules clearance.
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3 Conditions of use 3.1 Installation The installation of the HF400/HF440 shall be exclusively performed by a technician agreed by the distributor who will also be in charge of the periodic servicing. It is imperative that the following rules are rigorously followed by the users: 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 HF400/HF440
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.
If the machine is not used for more than 1 year, the battery should be removed by an agreed technician. Manufacturer maintains technical documentation available for technicians.
3.2 Mandatory controls before use The controls shown below shall be performed prior to any use of the HF400/HF440. If a defect is detected, or in case of doubt, the device must not be used. Blood detector
Clean without opaque deposit.
Clamp
Movement possible with a feeble resistance.
Screen
Clean, no opaque deposits.
Peristaltic pumps
No trace of internal wearing, normal resistance when closing
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3.3 Rules for use It is vital that users 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 connection after the rinsing. Replace the disposable (filter and tubing) before each treatment and when machine requests to do so. Make sure the sterile 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 all cases, the user shall observe their patient and make sure, as often as necessary, that the treatment continues correctly and safely. If the aforementioned rules are not respected, the hospital will hold entire responsibility for any damage or injury.
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3.4 Controlling patient's temperature The operator must check patients temperature as much as necessary during the whole treatment. A heater is available for the HF400/HF440 and should be used to prevent the patient from cooling when this is not desired for clinical reasons. The use of the heater is described later in this manual.
3.5 Cleaning and servicing to be performed by the user Element Procedure / product
Frequency
Using a soft piece of rag exclusively
Enclosure
Alcohol and if necessary organic acid (concentration < 5%) or mineral acid (concentration < 5%)
After each treatment and when needed
Screen
Alcohol only (all acids excluded).
When needed
3.6 Periodic controls Controls and preventive maintenance of the HF400/HF440 shall be performed by a technician agreed by the distributor. The periodic maintenance frequency is of 3'000 hours of utilisation but at least once a year. Maintenance and repair procedures are described in the HF400/HF440 maintenance manual. As soon as 3000 hours or 1 year has passed without maintenance, at each power-up of the machine a reminder is displayed. As soon as a machine fault is detected or suspected the machine must be checked by an agreed technician.
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4 Safety features Safety features implemented in the device :
stop the exchange and if necessary the blood pumps, display a clear message on the screen generate a sound and a blinking signal to inform the user that an abnormal condition has occurred.
In such cases the operator must follow the indications appearing on the screen and to those described in this operators manual. It is possible to suspend the audible alarm by pressing on the “silence” button described later in this manual. After this a 4 seconds alarm will come back as a reminder every 2 minutes. The sound alarm starts at a low level and increases automatically after 10 seconds. The alarms which stop the blood pump appear with a red background. In this case correction of the problem should be done quickly in order to prevent coagulation of the blood inside the extracorporeal circuit. Otherwise the background is white and in such cases the blood continues to circulate. The heparin pump is stopped whenever the blood pump is stopped.
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4.1 Detection of air on the blood return line The blood circuit includes 1 air detector that triggers an alarm closing the venous clamp and stopping all pumps as soon as air in the form of a bubble or foam, with a volume greater than 50 l, is detected. A procedure to remove air is then initiated.
4.2 Arterial pressure In order to protect the patient's vascular access, the pressure sensor placed before the blood pump constantly checks that the "arterial" pressure remains between the user-defined limits. Range of measurement: - 300 to +20 mmHg, precision: 10%
4.3 Venous pressure In order to help prevent patient's blood loss due to disconnection of the venous line, the pressure sensor located on the venous line generates an alarm as soon as the pressure is lower than the user-defined limits. Range of measurement: -20 to +300 mmHg, precision: 10%
4.4 Transmembrane pressure alarm When the TMP increases beyond it's boundary value an alarm is triggered. The user can then increase the blood flow or the predilution ratio or reduce the ultrafiltration flow.
4.5 Transfilter pressure The transfilter pressure is also monitored and generates an alarm indicating if there is possibly clotting when, in stable conditions, the pressure drop between filter inlet and outlet increases by 30%.
4.6 Blood leaks through the membrane Presence of blood in the waste may mean that the filter's membrane is broken. The blood leak detector generates an alarm when the absorption of light by the waste fluid is greater than the authorised value. Before acknowledging this alarm the user must make sure that there is effectively no blood present or blood coming from a problem which has been resolved. By acknowledging this alarm, the user takes the responsibility to set its level to a higher value thus indicating that the colour of waste is normal. The alarm level will automatically decrease when the waste becomes clearer. Boundary value: 0,2 ml of blood (HCT 0,32) / min.
4.7 Single needle cycle When either the arterial or venous cycle is too long during single needle treatments an alarm is generated. In this case connections should be checked.
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4.8 Fluid balance error When the system detects a fluid balance error of more than 5% and/or 30 grams, an alarm is generated. The fluid balance errors must not be validated more than 5 times per treatment as cumulated they may present a hazard for the patient.
4.9 Power failure Power failures are detected by the machine, which continues the treatment and restores all data when power is re-established. All pumps are stopped during the power failure. Warning : Pressing the machine's main switch during the treatment is not interpreted as a power failure. In such case, the system will assume that the treatment is ended. Therefore, after interrupting the system by pressing its main switch, it is not possible to continue the treatment.
4.10 Replacing the substitution fluid An alarm is triggered when the substitution bag's weight is lower than the one defined in the treatment parameters. The bags must then be replaced. Accepted range of measurement: 0 – 3 kg.
4.11 Replacing the waste container An alarm is triggered when the weight container waste is higher than the one defined in the treatment parameters. Accepted range of measurement: 1 – 16 kg or 1-42 kg (40 kg option on HF440)
4.12 Peripheral alarms The systems constantly checks that the machine’s peripherals (i.e. motors, scales, and supervisor) run correctly. Otherwise an alarm is generated. In such cases, the user must proceed to patient's blood return and call the agreed technician.
4.13 Manual blood return procedure In any case where the operator suspects that continuing treatment may be dangerous the recommended procedure for returning the blood is as follows : 1) Hang a saline fluid bag at the hook on the right side of the machine. 2) Disconnect the patient's arterial line and connect it to the aforementioned bag 3) Open the blood pump's cover and let the blood flow. 4) When the tube is free of blood, the patient can be disconnected. 5) Call the agreed technician to get the machine repaired. WARNING : During this procedure once the machine is turned off all the protections are deactivated. Thus the operator shall take special care to prevent dangerous conditions for the patient, in particular air bubbles injection and blood losses. Manual HF400 User ENG 3.25 V2 TekMed / 2009-04-21
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4.14 List of alarms: In the next table the different fields are defined as follow : -
No Cause Actions
: Alarm reference number appearing in the upper right corner : Cause of alarm : That must be taken to solve the alarm and continue operation
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No 1,2
Cause Main power failure
Actions Check the main power plug connection. If the failure is not due to the mains, disconnect patient and call the technical service
4
Upper air detector activated
Check that tube is correctly inserted in the detector. Press validate and follow the procedure displayed on the screen.
5
Lower air detector activated
Check that tube is correctly inserted in the detector. Press validate and follow the procedure displayed on the screen.
6
Air detector selftest failed
The treatment cannot be started. Power off and on the machine again. If alarm comes again call a technician.
7
Pressure arterial too low or pressure venous too high for too long time.
Check for any clamp in the venous, arterial line and the filter. Check if the catheter is well placed. If necessary, adapt the pressures limits.
8
9
Venous pressure is below the specified minimum.
Check that there is no disconnection of the venous line.
The arterial pressure is below the specified minimum.
Check that the blood flow is appropriate to the vascular access and reduce the blood flow if not.
Press validate and adjust pressure limit if necessary.
Press validate and adjust pressure limit if necessary. 10
The venous line is not inserted in the clamp.
Check that the line is inserted in the clamp.
11
The clamp should be closed but is open.
Check that the clamp movement is not blocked.
15
The main unit is not responding.
Major hardware failure window. Contact technical support
16
The main unit clock is too fast.
Major hardware failure window. Contact technical support
17
The main unit clock is too slow.
Major hardware failure window. Contact technical support
18
Communication error between main Major hardware failure window. Contact technical support unit and supervisor board.
19
The venous pressure is above the specified maximum.
Push the clamp one or two times in order to readjust its position.
Check for any clamps on the venous line or clotting inside the bubble trap. Check that the blood flow is coherent with the vascular access and reduce blood flow if not. Press validate and adjust pressure limits if necessary.
20
The arterial pressure is above the specified maximum.
Check for any arterial line disconnection. Press validate and adjust pressure limits if necessary.
21
The filter transmembrane pressure Reduce the UF or plasma flow, rinse the filter with saline, end is above the specified maximum. the treatment or increase the alarm limit.
22
Problem with the heater (for China) Turn OFF/ON heater. If problem persists, continue or finish treatment without heater and call technician.
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25
The machine temperature is above Check that the HF400/HF440 is not directly exposed to the the alarm level of 60°C. sun and that air is coming out of HF400/HF440 vents on the back
26
The machine temperature is below Leave the HF400/HF440 warm up for 10 minutes before the alarm level of 0°C validating
27
Blood detected (MP400)
If there is no blood leak validate to continue the treatment. In case of blood leak terminate the treatment and return blood to the patient.
28
Blood detector (MP400) is not running properly
Check that the detector chamber and lenses are clean.
29
Blood detected in waste
If there is no blood leak validate to continue the treatment. In case of blood leak terminate the treatment and return blood to the patient.
30
Blood detector (CM400) is not running properly
31, 35 The blood pump is stuck
Check that the detector chamber and lenses are clean.
Check that the blood pump is not blocked and validate. If the problem remains return blood manually.
32, 36 The waste pump is stuck
Check that the waste pump is not blocked and validate. If the problem remains end the treatment.
33, 37 The substitution pump is stuck
Check that the substitution pump is not blocked and validate. If the problem remains end the treatment.
34, 38 The predilution/dialysate pump is stuck
Check that the predilution/dialysate pump is not blocked and validate. If the problem remains end the treatment.
39
The blood pump cannot be stopped.
Validate. If the problem remains return blood manually and end the treatment.
40
The waste pump cannot be stopped.
Validate. If the problem remains return blood and end the treatment.
41
The substitution pump cannot be stopped.
Validate. If the problem remains return blood and end the treatment.
42
The Predilution/dialysate pump cannot be stopped.
Validate. If the problem remains return blood and end the treatment.
47
Protective unit, the supplies/losses Validate. If the problem remains return blood and end the calculation may be wrong. treatment.
48
Protective unit, the weight loss/gain Validate. If the problem remains return blood and end the calculation may be wrong. treatment.
49
Protective unit, the waste flow on scale does not correspond to the pump value
Check that the UF line is not clamped or leaking and that the filter is not clotting. Validate. If the problem remains return blood and end the treatment.
50
Protective unit, the substitution flow Check that the substitution line is not clamped or leaking. on scale does not correspond to the Validate. If the problem remains return blood and end the pumps value treatment.
51
The blood leak chamber is not properly inserted in the detector. (CM400)
Check that the blood leak chamber is correctly inserted in the detector.
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52, 53, Error on permanent CM400 data 54
Validate. If the problem persists return blood and end the treatment.
55
The upper blood leak chamber is not properly inserted in the detector.
Check that the blood leak chamber is correctly inserted in the detector.
56
Error on heparin pump position
Check that the syringe is not jammed and validate
57
Heparin syringe is empty
Replace the heparin syringe with a filled one
62
Temperature sensor P10 from MP400 is not working properly
Treatment will run without heater.
Temperature sensor P12 from MP400 is not working properly
Treatment will run without heater.
64
65
Heater temperature is too low
Call technical support.
Call technical support. Treatment will run without heater. Call technical support if problem persists.
66
Heater temperature is too high (regulation part)
Heater is automatically turned off. It will restart as soon as the temperature reaches an acceptable level.
67
Heater temperature is too high (security part)
Heater is automatically turned off. It will restart as soon as the temperature reaches an acceptable level.
68
Heater selftest failed
Treatment will run without heater. Call technical support. Close the heater door. - If the heater is used and door closed, check that there is no clamp in the tubing of the heater part. - Call technical support if problem persists.
69
Door of heater open
70
Control and protective temperatures are different
Heater will be stopped for the rest of treatment. Call a technician.
76
Heater is still too hot
Treatment will pause, wait until the heater is no more in pause before restarting
100
Priming phase is too long. Expected mass of Uf is smaller than Re
- Check for loose connectors - Check that the tubes connections are as described by the pictures - Check the filter volume
101
Priming phase is too long. - Check for loose connectors Expected mass of Uf is greater than - Check that the tubes connections are as described by the Re pictures - Check the filter volume
102
Priming phase is too long. - Check for loose connectors Expected mass of waste is greater - Check that the tubes connections are as described by the than that of substitution pictures - Check the filter volume
127
Technical problem
Validate and call technical support
128
Technical problem
Validate and call technical support
129
Air detection during rinsing phase
Check for an air entry in the set Rinsing will start again from the beginning.
130
The software version of CM400 is Call technician. not compatible with the BC version.
131
The software version of PIC 1 in the Call technician. MP400 is not compatible with the BC version. Manual HF400 User ENG 3.25 V2 TekMed / 2009-04-21
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132
The software version of PIC 2 in the Call technician. MP400 is not compatible with the BC software version.
133
Scales communication error
Validate. If the problem remains return blood and end the treatment.
134
Instability detected on scales
Check that the fluids are not moving and validate
135
Mass on one of the scales too high Empty the extraction container. If the alarm continues, check or too low the extraction tray.
136
Detection of a non null flow on a stopped Uf scale.
- Check that the pumps are closed. - Check that the clamp near the drip chamber is closed. - Check that the pumps are occlusive. - Pay special attention to the patient. He may be loosing weight.
137
Detection of a non null flow on a stopped Re scale.
- Check that the pumps are closed. - Check that the clamp near the drip chamber is closed. - Check that the pumps are occlusive. - Pay special attention to the patient. He may be loosing weight.
140
Waste container is full.
Empty the waste container.
141
The substitution container is empty Replace the substitution container with a full one.
142
The flow on the extraction scale is not the expected one
143
The flow on the substitution scale is Check the tubing for any unexpected clamp. not the expected one
145
Problem to set the desired temperature in the heater.
If problem persists, call technician.
146
Problem of reading the scales values (filtration time)
Wait, If the problem persists, call technician.
150
Air detector test failed.
Check that the line is completely filled with liquid and push the tube further inside the sensor.
153
Visual and sound alarm test failed
Power off and on the machine again.
154
Pump emergency stop test failed
Power off and on the machine again.
155
Venous clamp test failure.
Move the clamp manually and ensure it is not stuck
156
Scales precision test failed
Check that the clamp near the drip chamber is open, that the bubble trap is filled and that the substitution container is not clamped.
Check the tubing for any unexpected clamp.
Check the UF line is positioned in container 157
The bicarbonate line detection failed. The mass transfer was not as expected.
Until release 2.82 only
158
During scale test a too high flow is detected on the substitution scale
Check that the tubing set is a paediatric one
159
During scale test a too low flow is detected on the substitution scale
Check that the set is an adult one. Check that the substitution pump segment has no default.
Manual HF400 User ENG 3.25 V2 TekMed / 21-Apr-09
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160
Battery test failure
Power the machine off and on again.
161
Pressure test failed. Pressure doesn’t increase in the circuit.
Check that the clamp near the drip chamber is closed, that the pressure filter membranes are dry and that there is no leak in the fluid circuit
162
Pressure test failed. The sensors are not accurate.
Check that the clamp near the drip chamber is closed, that the pressure filter membranes are dry and that there is no leak in the fluid circuit
163
Pressure test failed. Pressures aren’t reduced as expected.
Check that venous and arterial clamps are not closed
164
The battery is not connected
Power off and on the machine again.
165
Impossible to set prefilter pressure Check that the prefilter pressure sensor is correctly above 0 connected and its membrane is exempt of any liquid. Check that the clamp near the bubble trap is closed
166
Impossible to set venous pressure above 0
Check that the venous pressure sensor is correctly connected and its membrane is exempt of any liquid. Check that the clamp near the bubble trap is closed
167
Impossible to set venous and prefilter pressure above 0
Check that both pressure filters are correctly connected and their membranes are exempt of liquid. Check for any leak in the circuit.
168 169
170
171
172
173
174
175 176
Impossible to raise prefilter pressure Impossible to raise venous pressure
Open and close the clamp near the bubble trap. Check that pressure filter membrane is exempt of liquid Open and close the clamp near the bubble trap. Check that pressure filter membrane is exempt of liquid Open and close the clamp near the bubble trap.
Impossible to raise venous and prefilter pressure
Check that both pressure filter membranes are exempt of liquid Check for any leak Open and close the clamp near the bubble trap. Impossible to set arterial pressure Check that pressure filter is correctly connected and its below 0 membrane is exempt of liquid Open and close the clamp near the bubble trap. Impossible to set UF pressure Check that pressure filter is correctly connected and its below 0 membrane is exempt of liquid Open and close the clamp near the bubble trap Impossible to set arterial and UF Check that pressure sensors are correctly connected and pressure below 0 their membranes are exempt of liquid Check for any leak in the circuit Open and close the clamp near the bubble trap. Impossible to drop arterial pressure Check that pressure filter membrane is clear of liquid The filter may have a default Open and close the clamp near the bubble trap. Impossible to drop UF pressure Check that pressure filter membrane is clear of liquid Open and close the clamp near the bubble trap. Impossible to drop arterial and UF Check that pressure filter membranes are clear of liquid pressure Check for any leak in the circuit Open and close the clamp near the bubble trap.
Manual HF400 User ENG 3.25 V2 TekMed / 2009-04-21
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