上海翻译公司完成连续性血液净化机用户手册英文翻译_世联翻译公司

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上海翻译公司完成连续性血液净化机用户手册英文翻译

上海翻译公司完成连续性血液净化机用户手册英文翻译
Intended use
KIBOU is a multifunctional automatic machine, for the delivery, performing and the control of continuous purifying treatment (CRRT - Continuous Renal Replacement Therapy). Such treatment is normally indicated to restore or replace the kidney functioning in patients affected by acute renal failure, (both isolated and concomitant with multiorgan failure syndrome), sepsis or others diseases which by their nature influence, temporarily or completely, the kidney function.
 
The machine can be used to perform the following types of treatment:
 
·       CVVH (Continuous Venous Venous Hemofiltration)
·       CVVHD (Continuous Venous Venous Hemodialysis)
·       CVVHDF (Continuous Venous Venous Hemodiafiltration)
·       SCUF (Slow Continuous Ultrafiltration)
 
In those cases is necessary to substitute plasma fluid the machine allows to perform TPE treatment as above listed.
 
  • TPE (Therapeutic Plasma Exchange)
 
The machine is intended for use on Adults and Pediatrics patients, and allow to use also two different type of anticoagulant therapy, Heparin and Calcium-Citrate.
In adults patient it is possible use both anticoagulant therapy instead in the pediatrics patients it is possible use heparin therapy only.

 
The previous indication is described in the following list:
 
CRRT Treatment Adult Pediatric
Heparin Calcium-Citrate Heparin Calcium-Citrate
CVVH OK OK OK NO
CVVHD OK OK OK NO
CVVHDF OK OK OK NO
SCUF OK OK OK NO
TPE OK OK OK NO
 
 
CVVH
 
CVVH, or Continuous Venous Venous Hemofiltration, is simply, as evident from the definition, a continuous hemofiltration treatment which can takes many hours.
In CVVH blood is withdrawn and returned to the patient through a venous access, and is passed through a high permeability membrane by means of a pump. Due to the high permeability characteristics of the filter, an important amount of fluids and solutes (even of middle to high molecular weight) are removed from the blood
The ultrafiltrate produced during the transit across the membrane is partially or completely replaced with appropriate replacement solutions to achieve the blood purification and volume control.
Ultrafiltration exceeding the reinfused amount represents the patient weight loss.
 

CVVHD
 
 
The CVVHD technique, or Continuous Venous Venous Hemodialysis, is characterised by a dialysate liquid circulation into the ultrafiltrate/dialysate compartment of the filter.
The blood is driven to the filter by a peristaltic pump across a circuit, which begins, and ends, into a vein.
The purification is mostly diffusive and the membranes used can be either synthetics or cellulose.
 
 
CVVHDF
 
 
The CVVHDF, or Continuous Venous Venous Hemodiafiltration, is practically a CVVH; modified with the addition of a circulating dialysate fluid into the dialysate/ultrafiltrate compartment of the filter.
The ultrafiltration rate is higher than the expected weight loss and for this reason routinely a replacement fluid solution is needed to achieve the desired fluid balance.
The solute purification is both diffusive and convective, the vascular access to the patient is normally venous, and the membranes used are synthetic and highly permeable.
 
 
 
SCUF
 
 
SCUF, or Slow Continuous Ultrafiltration, is a form of CVVH without the associated fluid replacement. It is often performed in the management of refractory edema, whether or not ARF is present.
The primary target of this technique is to achieve an efficacious and safe control of the body water overload and for this reason it needs an accurate ultrafiltration control to keep the ultrafiltration rate at the right point to avoid the fluid replacement need.
The technique is normally applied on patients affected by pump disorders or congestive heart failure; its use for several days can improve the haemodynamic conditions of the patients and brings the cardiac activity back to the normal stage.
Normally the membranes used for the treatment are high permeability synthetic ones.
 
 
TPE
 
The TPE (Therapeutic Plasma Exchange ) ,  is basically similar to a CVVH treatment conducted to obtain a weight change rate mostly of the cases equal to zero.
Obviously the filter element is a plasmafilter which allows to remove plasma and its macrocomponents from the patient’s blood .
The blood is driven to the filter by the blood pump and the plasma removed/ultrafiltrate is collected in a proper waste bag. By a dedicated plasma replacement pump the exhaust plasma removed is replaced by fresh one . Is also possible to perform treatments with a fluid balance either positive or negative.
 
Connection with other medical devices
Performing treatments with KIBOU has to be managed with a single use tubing set, which groups in a compact and integrated form the extracorporeal blood circuit and both the replacement fluid circuit and the ultrafiltrate collecting one.

Accessories
 
There are three type of single use tubing set for KIBOU:
·         Adult single use tubing set for heparine
·         Pediatric single use tubing set for heparine
·         Adult single use tubing set for citrate
 
WARNING: The above mentioned devices must be used under medical control and by qualified personnel.
 
Contraindications
 
 
KIBOU has not been designed, or been sold, nor its’ use intended for anything else which have not been indicated in the previous paragraph.
Do not use KIBOU if the patients’ treatment requires performances outside of its’ operating range, accuracy and safety limits, as specified in this Instruction Manual.
 
 
Safety philosophy
 
The electronic architecture of KIBOU is based on three main microprocessors. One of these manages and controls the users interface and the command panel, while the others two work to control and monitor the system.
In particular the control microprocessor performs the real commands of all the KIBOUs’ main components, (such as pumps, transducer, load cells etc.) while the second microprocessor (monitor) monitors the activities of the first one.
Thanks to this architecture, if a single failure occurs, KIBOU will enter a safety condition, which will prevent the use of the system.
 

Responsibility of the manufacturer
 
Medica is responsible for the safety, reliability and service of the equipment only when used according to the directions included in this Instruction Manual, and used with electrical connections in compliance with the regulations in force.
 
MEDICA is a certified company and operates in observance of the law and in compliance with :
 
    UNI EN  ISO  9001   : 2008
    UNI EN  ISO  13485 : 2012
 
 
 
Storage
 
After use, store KIBOU with its accessories must be stored in a suitable place, not subject to adverse weather conditions. If is necessary to clean the pump, use a soft cloth and a mild detergent without corrosive chemicals.  Please note that KIBOU is not waterproof, so do not spray nor pour liquids directly on the unit.
We recommend to cover KIBOU with a plastic bag to protect it from dust or dirt, and to store it in a suitable place safe from possible impacts.
 
 
Cleaning
 
 
If it is necessary to clean the device, use a soft cloth and a mild detergent or alcool without corrosive chemicals.
Please note that KIBOU is not waterproof, so do not spray nor pour liquids directly on the unit.
 
Warning! If you need to cleaning the metallic plate heaters, before cleaning, power off the system and wait 15 minutes. To remove the heater cover, push the cover in right direction.
 
Disposal Of Waste
 
The Medical Device, as become waste, must be disposed according to the disposition of Single State Laws.
 
Respect to European Community :
 
The Device can be disposed according to Council Directive n° 2002/96, as assimilated on Single State Laws system.
The Device conforms to Council Directive 2002/95, as assimilated on Single State Laws system
 
WARNING : For a correct disposal, please take care the relevant state laws and clinic procedures, related to contaminated products handling and discarding.
 
 
 
Disposal of the packaging
 
The packaging of MEDICA has to be discarded according to the rules in force.
 
Warranty
 
MEDICA guarantees KIBOU for a period of 24 months from the the  date of delivery  to the customer.
During this period, the correct functioning of the unit is guaranteed against defects in materials and workmanship.
MEDICA disclaims any responsibility for damage or injury caused by KIBOU resulting from maintenance carried out by unauthorised personnel.
Any unauthorised maintenance during the warranty period will immediately void this warranty.
MEDICA decline all responsibility for the effect(s) that such unauthorised maintenance involving the use of KIBOU on person and/or things.
MEDICA will, at its sole discretion, repair or replace, in MEDICA’s plant, free of charge, those components that prove to be defective due to an original defect in materials or workmanship.
The purchaser must pay the shipping charges to MEDICA’s service facility.
This warranty does not cover any defective parts and components as a result of negligence or improper use, incorrect installation or maintenance, careless transportation and handling, or to any circumstances that are not the direct result of manufacturing defects.
In the event of manufacturing defects, this warranty covers the repairs. Replacement and compensation for direct or consequential damage or injury resulting from the inability of the unit to operate are not covered by this warranty.
MEDICA disclaims any responsibility for any damage direct or consequential, resulting from a failure to comply with the provisions of KIBOU installation, use and maintenance instruction.
Defective parts replaced on warranty will remain the property of MEDICA
In case of disputes any legal action will be brought in a court of Italy.

 
The purchase of KIBOU and the delivery of this Instruction Manual establish total acceptance of the above mentioned warranty’s conditions. Any other previous warranties, either expressed or implied, are excluded by this one.
For further information or clarification concerning use, maintenance and technical service of KIBOU please contact our local distributor or:
 
 
·       For the safety of the patient, the use of KIBOU needs the supervision of trained and qualified personnel.
 
·  OPERATOR POSITION during the treatment:
o    If the operator operates on the device or on the patient, it is at the distance di about 50 cm from the device.
o    If the operator does not operate on the device or on the patient, it is on the room of the machine or at the distance that allows him to hear acoustic alarms and/or to see the visual alarms.
 
·       Before starting to work with KIBOU this Instruction Manual has to be read and understood. MEDICA is not responsible for any injury further to wrong or non-application of the instructions of this Instruction Manual.
 
·         Keep this Instruction Manual within reach of the operators, and store in order to guarantee its availability and the integrity.
 
·           In the case of loss, or if undelivered please request immediately a copy of this Instruction Manual from MEDICA, or from the local distributor.
 
·           Do not operate  KIBOU without having a precise knowledge of the treatment that KIBOU can perform.
 
·           Before starting to operate KIBOU be sure that all the foreseen instructions have been made to preserve a complete and safe installation (see the service manual).
 
·         When the protection systems are temporarily deactivated for the minimum reinfusion pressure (10 seconds) and minimum BLD pressure (30 seconds) thresholds, the operator is responsible for monitoring the parameters.
 
·           Any narrow passages in the EXTRACORPOREAL CIRCUIT (such as kinks in the blood line or cannula that are too thin) may cause haemolysis and that this HAZARDOUS SITUATION may not be detected by the device PROTECTIVE SYSTEMS.
 
·           Apply the break on the front wheels in order to limit movement. Avoid pulling the blood tubing set connected to the patient.
 
·           Avoid to use mobile phone near the equipment.
 
·           To connect KIBOU to the electric network use only the specially equipped electric cable.
 
·           Avoid using extension cables or converter. Do not cut or remove the earth/grounding contact from the connecting plug.
 
·           Be sure that the electrical network supplies’ nominal value is suitable for the  technical features of KIBOU and the wiring is conform to the in force electrical norms.
 
·           The precision of KIBOU in the control and in the fluid balance of the patient depends largely upon a careful calibration of the load cell used by the three scales. Check the calibration of the cells and others sensors according to the time indicated in the Service Manual.
 
·           KIBOU has been developed with a safety system on the back filtration as the UF clamp opening is always paired with negative pressure depending on the difference between the filter heigth and the ultrafiltration bag.
In treatments where dialysis fluid is used the UF clamp will open for both Ultrafiltration flow and dialysis flow; in case of malfunctioning of the UF clamp a dialysis weigth variance alarm will occur.
 
·           Be sure of the correct function of the control panel and of the graphic display, verifying that the information on it meets the stated ones. Do not use KIBOU if there are inconsistencies between the parameters on the display and the parameters the operator had stated. In this case advise the Technical Assistance Service.
 
·           Be sure that when the keys are pushed there is also an acoustic signal that confirms that the command has been effected.
 
·           Depress only one key at a time on the control panel keypad, as KIBOU will accept only the latest key pushed.
 
·           If the display becomes black or not readable during the treatment, this latter has to be finished and the Technical Assistance Service has to be advised.
 
·           Before and after using the disposable set, clean the inox connections for the pressures reading
 
·           The use of KIBOU is recommended only with medical disposable tubing sets approved by MEDICA. Do not use KIBOU with disposables not complying with the MEDICA specifications.
 
·           The KIBOU’s medical disposable tubing sets are supplied sterile and non-pyrogenic. Check the integrity of the sterilisation pouch and do not use it if damaged or opened.
 
·           Open the pouch with care and use aseptic techniques to preserve sterility.
 
·           Use the disposable as soon as the pouch is opened, avoid to postpone its’ use.
 
·           The bags for replacement or dialysate solutions have to be suspended from the special hooks of the relevant scales. Avoid to suspend other objects from the hooks of the scales as they can influence the fluid balance and thereby the patient’s weight.
 
·           Use replacement or dialysate solutions in compliance with prescription and national regulations relating to registrations, rules and directive in force. Check also, before use, that there are no precipitates in these solutions.
 
·           The bag for ultrafiltrate solution has to be put on the special scale. Avoid putting other object on it as they also could influence the fluid balance and the patient weight
 
·           Handle the tubing set with care, using relevant precautions to reduce the risk of exposure or transmission of infections like HIV and HCV.
 
·           When any alarm(s) are activated refer to this Instruction Manual or start up with the On-Line Guide of KIBOU and follow the instructions.
 
·           KIBOU points out to the operator when the fluid’s bags used during the treatment have to be replaced. Refer to the instructions on the display to proceed with the replacement.
 
·           Before Priming, check every time all the connections of the tubing set on the ultrafiltration compartment.
 
·           The KIBOU tubing circuit is a Single-Use-Only, disposable product. It cannot be resterilised or reused. Dispose in accordance with local sanitary laws.
 
·           Do not repair or service, without competence or without the authorisation of MEDICA or of their authorised distributors. KIBOU does not contain devices that can be repaired by the operator. Repairs and service have to be made only by personnel authorised by MEDICA.
 
·           Carry out the regular maintenance of the KIBOU as advised by MEDICA. Refer to this Instruction Manual or to the Service Manual.
 
·           Do not use KIBOU in place where gas or inflammables are in use.
 
·           Before starting to clean or carry out maintenance on KIBOU, disconnect the equipment from electric current.
 
·           Do not remove the labels and the identification symbols from the panels or frame of KIBOU.
 
·           Do not use detergent or chemical agents that can damage the external surface of KIBOU. Do not damage symbols and identification labels. Refer to section of this Instruction Manual relating to the maintenance and the service periods. In order not to damage the device, during cleaning operation, use only damp cloth, do not throw liquid on the device.
 
·           Avoid contact between the KIBOU tubing set and chemical substances or solvents that could be dangerous for the integrity of the disposable. When in doubt do not use the kit.
 
·         Do not use any kind of lubricating substances on the internal or external components of KIBOU as they could influence negatively the working of KIBOU.
 
·         Remove the weights from the KIBOU’s pole during the movement.
 
Safety warnings for service operators
 
Safety warnings for service operators:
·         Only service qualified operators can make service
·         Power off the device and disconnect the power supply cable before open the device housing for technical service operations.
·         Before the heater substitution: power off the device, disconnect the power supply cable and wait 15 minutes.
·         Do not attempt any repairs or maintenance’s of any kind on the device without the necessary knowledge or preparation; and without being specifically authorised by MEDICA or their authorised dealers.
·         MEDICA will not accept liability for any reason in case of incidents or damage occurred to the patient or to the users, arising from misuse of the instructions given in Service Manual.
 
 

 
Power ON, system setting up and treatment
 
WARNING: the device is CLASS I equipment than it is important that the protective earth in the electrical installation is in compliance with the applicable norms.
 
To turn on the device, press the main switch on the rear panel to get the “ ON “ position.
 
After verifying the green lamp is light on the front panel, press the light key onto the front keyboard; the “HOMEPAGE”  will appear in about 30s.

START PREPARATION is used to start a new treatment;
MAINTENANCE is used to perform service operations, such as calibration;
INITIAL SETUP is used to configure defaults, such as filter type, anticoagulant, language, etc…
TREATMENTS HISTORY is used to review statistical data about last 10 executed treatments.
 
In order to enable CRRT to warm up the electronics to a proper temperature range, and stabilise it, it is recommended to wait for 10 minutes before starting treatment procedure.


Initial setup
 
By means of initial setup screen, it is possible to configure the device according to the clinic’s practices. Initial setup screen is divided in several pages; user can navigate through pages using the ‘Prev’ and ‘Next’ buttons at the bottom of the screen.
The ‘Back’ button can be used to exit the Initial Setup without saving the modifications.

In the first page the following choices can be done:
FILTER TYPE: The device can work with two different types of filters. WET or DRY. It is important to choose the right type of filter because a wrong choice could damage the filter during priming.
WORKING MODE: Working mode allows to choose how targets of the treatment will be set. In ‘Flow Mode’, the user will set the Post-Dilution flow, Pre-Dilution flow, Dialysate flow and Fluid Loss rate, while in ‘Volume Mode’ the user will set the Total Volume of Post-Dilution, Pre-Dilution, Dialysate, Fluid Loss and the Treatment Time. The choice is done only accordingly to the clinic’s common practice.
PATIENT: Sets the default for Adult/Pediatric tubing sets. This choice can be modified, for the single treatment, before starting the treatment.
ANTICOAGULANT: Sets the default for the anticoagulant. This choice can be modified, for the single treatment, before starting the treatment. The device supports, as anticoagulant, Heparine or Citrate.
BLOOD-DIALYSATE FLOW DIRECTION. In CVVHD and CVVHDF, the device can work with dialysate flowing co-current or counter-current with respect to the blood flow. This choice cannot be modified before starting the treatment.

The second page allows to set the solution for calcium and citrate, in case Citrate is the chosen anticoagulant.
Citrate Solution, is the solution used to infuse citrate hanged to the citrate scale, Calcium solution is the solution used in the syringe, dialysate/replacement solution, is the solution used as replacement and/or dialysate: if no calcium is present in the solution, ‘Calcium Free Dialysate’ must be chosen.

The third page allows to set system date and time and system language.
This settings are saved by their dedicated ‘SET’ buttons.
When one changes the system language, to see the effect of the change, the device must be restarted.
 
 

Use of anticoagulants
 
 
The device supports two different anticoagulants: Heparin and Citrate.
 
Two different tubing set must be used accordingly to anticoagulant choice:
·  The tubing set for heparine does not have a line going through citrate pump, which remains unused and the line from the syringe connects before the venous chamber;
·  The tubing set for Citrate has the additional line through citrate pump and the line from syringe (for calcium infusion) connects just after the venous return.
 
 
HEPARINE
In case of heparine, only syringe pump is used. Heparin flow rate will be chosen among other treatment parameters and it will be possible to deliver bolus, on demand, during the treatment. The amount of the bolus is selectable.
 
CITRATE
In case of citrate, a citrate solution is hanged to the citrate scale, as explained by on-line help in PREPARATION screen. Citrate flow rate is set among other treatment parameters as a function of blood flow rate.
The syringe pump is used to deliver calcium to the patient, needed during citrate infusion to compensate for calcium absorbtion caused by citrate. The calcium infusion flow rate is set among other treatment parameters as a function of the ultrafiltration flow rate.
It is not possible to deliver bolus of citrate or calcium.
 
Anticoagulant and patient (adult or pediatric) are automatically set as the default, but can be changed for the specific treatment. To change the default, go to the INITIAL SETUP screen from the HOME page.
 
NOTE: with the pediatric mode the anti-coagulant is always Heparin.
 
Press PREPARATION button to start the disposable assembly:
 
WARNING FOR THE OPERATOR. A BAD CONNECTION OF THE EXTRACORPOREAL CIRCUIT COULD CAUSE A SEVERE BLOOD LEAKAGE OR PREVENT THE PROPER EXECUTION OF THE TREATMENT.
 
 
The “PREPARATION” screen allows displaying assembly steps with description and images; press NEXT button (on the screen topside) to display the next step, or click on the step number to jump back and forth to a desired step.
Pressing the BACK button it is possible to return to “SELECT TREATMENT” screen.
 

Priming
 
 
PRIMING PROCEDURE FOR CVVH (PRE-POST)/CVVHD/CVVHDF
 
1.     After assembling the disposable, press PRIMING button to enter in the “PRIMING” screen.
2.     The priming immediately start.
3.     During each priming phase the device automatically executes a test for the integrity of the motors safety relay, the integrity of the venous clamp and the main hardware components of the system. If test is not passed, it can be repeated; if not passed again, the procedure cannot proceed.
4.     The machine prepares itself for the mounting of tubing set:
·         The venous clamp is opened;
·         Both ways of the selection clamp are opened;
·         Rotors of all peristaltic pumps are moved to “mount” position;
·         Reference pressure values for each dome pressure sensor are saved;
5.     Place a saline solution bag onto the machine pole;
6.     Mount the Filter for the treatment;
7.     Mount the arterial line:
·         Connect the spike to the saline solution bag and close the red clamp;
·         Connect the dome pressure sensor of the arterial pressure;
·         Open the cover of the blood pump;
·         Introduce the blood pump segment of the line;
·         Close the cover of the blood pump;
·         Connect the dome pressure sensor of pre-filter pressure
·         Connect the exit of the arterial line to the lower inlet of the filter.
8.     Hang the empty bags for UF to the ultrafiltration scale;
9.     Mount the Venous line:
·         Connect the upper outlet of the filter to the venous line;
·         Connect the blood-catcher for the venous pressure;
·         Place the venous chamber in its support;
·         Place the line exiting the venous chamber in the bubble detector;
·         Place the line exiting the bubble detector in the venous clamp;
·         Connect the end of the venous line to a 2L priming bag;
·         Hang the 2L priming bag to the UF Scale.
10.  Hang the infusion bags to the infusion scale;
11.  Mount the ultrafiltration line:
·         Connect the line to the upper inlet of the dialysis side of the filter;
·         Verify the lower inlet of the dialysis side of the filter be closed with a luer cap;
·         Mount the dome of the ultrafiltration pressure;
·         Open the cover of the ultrafitration pump;
·         Introduce the blood pump segment;
·         Close the cover of the ultrafiltration pump;
·         Introduce the line in the blood leak detector;
·         Connect the end of the UF line to the waste bags;
12.  Mount the infusion line:
·         Open the cover of the infusion pump;
·         Introduce the blood pump segment of the infusion line;
·         Close the cover of the infusion pump;
·         Insert the heater bag inside the heater from the slot on heater left side;
·         Open the cover of the dialysis/pre-dilution pump;
·         Introduce the blood pump segment of the dialysis/pre-dilution line inside the pump;
·         Close the cover of dialysis/pre-dilution pump;
·         Connect the post-dilution outlet of the heater to the venous drip chamber;
·         Connect the dialysis/pre-dilution outlet of the heater to the switching clamp;
·         Connect the dialysis outlet of the switching clamp to the dialysis filter side;
·         Connect the pre-dilution outlet of the filter to pre-filter dome;
·         Connect the infusion line to the infusion bags;
13.  Confirm tubing set is mounted.
14.  Automatic check of Dome sensors.
15.  Open the blue clamp on venous line.
16.  Confirm opening of the clamp.
17.  Dome sensors on arterial, venous and pre-filter lines are activated to check eventual occlusions due, for instance, to a forgotten clamp.
18.  The switch clamp closes the dialysis outlet and leave the pre-dilution line open.
19.  Pumps are started:
·         Blood pump 200ml/min.
·         Dialysis pump 100ml/min.
20.  Flow/Weight controls are activated.
21.  After 100ml dialysis/pre-dilution pump is stopped.
22.  Switching clamp opens the dialysis outlet and closes pre-dilution line.
23.  Dialysis/pre-dilution pump inverts rotation direction, sucking from dialysis side of the filter, with a flux of 80ml/min. Contemporarily, infusion pump starts at a speed of 150ml/min and UF pump ad a speed of 20ml/min (above mentioned speeds depend on filter type).
24.  When UF scale reaches a weight of 100g  higher than the weight recorded in step 19, dialysis and UF pump stops.
25.  The infusion pump continue continues to run.
26.  After 100ml post-dilution pump stops.
27.  Blood pump continues working, meanwhile the level pump for the drip chamber sucks air trying to stabilize the level in the chamber.
28.  When the level has remained stable for 20s.
29.  Blood pump speed is reduced to 100ml/min and venous clamp is closed.
30.  Venous, pre-filter and ultra filtrate pressures are monitored.
31.  When at least one of the three pressures reaches the value of 250mmHg, the blood pump is stopped.
32.  If, after 30s no one of the three pressures reaches the target value, a warning message will appear.
33.  Wait 10s to stabilize pressures.
34.  Verifies that all three pressures are equals in a range of max 20mmHg. If the test is not passed, a warning appear showing the sensor having problems.
35.  Venous clamp is opened.
36.  Blood pump runs at 200ml/min.
37.  Syringe pump delivers a bolus of 1ml.
38.  If Citrate has been selected as anticoagulant, the citrate pump starts at 20ml/min and runs up to 10ml.
39.  Verifies bubble detector.
40.  Verifies BLD.
41.  END PRIMING  
 
 
This screen contains the following functions:
 
SETTINGS Allows to set-up treatment parameters; this operation can be done at any moment during priming.
RECIRCULATION It is active only at the end of priming.
It allows remaining in the priming phase with only blood pump in function.
ADD. PRIMING It is active only at the end of priming .
It allows choosing which part of line will execute a new priming: blood-side or dialysate side.
 
 
During the priming phase it is necessary to adjust the level of physiological solution within the venous drip chamber by pressing the arrow button.
Treatment Parameters Unit Range Default Resolution Description
CVVH CVVHD CVVHDF SCUF TPE     Min Max      
X   X     Post-Dilution Flow ml/h 10 12000 0 10 In flow mode, determine the flow of replacement fluid in post-dilution
X         Pre-dilution Flow ml/h 10 12000 0 10 In flow mode, determine the flow of replacement fluid in pre-dilution
  X X     Dialysate Flow ml/h 1 12000 0 10 In flow mode, determine the flow of dialysate fluid
        X UF Flow / Blood Flow % 1 33 0 1 Determine the percentage of UF flow with respect to blood flow
        X Repl.Flow / UF Flow % 80 120 100 1 Determine the percentage of replacement flow woth respect to UF flow
X X X X   Fluid Loss Rate ml/h 0 1500 0 10 Determine the fluid loss rate
X   X     Post-Dilution Total l 0 500 0 5 In volume mode, determine the total of replacement fluid in post-dilution
X         Pre-Dilution Total l 0 500 0 5 In volume mode, determine the total of replacement fluid in pre-dilution
  X X     Dialysate Fluid Total l 0 500 0 5 In volume mode, determine the total of dialysate fluid
        X Plasma Volume ml 500 50000 0 100 In volume mode, determine the total of plasma exchanged
X X X X   Treatment Time h:m 10 4320 0 100 In volume mode, determine the duration of the treatment
X X X X   Total Fluid Loss ml 0 10000 0 10 Determine the total fluid loss: when total fluid loss is reached, treatment is stopped
X X X X X TMP Maximum mmHg 0 500 250 5 Determine the threshold for the maximum TMP alarm
X X X X X Heparin Flow ml/h 0 20 0 0.1 Determine the flow of heparyne
X X X X X Heparin Bolus ml 0 2 0 0.1 Determine the amount of heparine delivered with bolus
X X X X X Calcium Flow mmol/lUF         Determine the Calcium flow with respect to UF flow
X X X X X Citrate Flow mmol/lBLD         Determine the citrate flow with respect to blood flow
X   X     Replacement Temperature °C 30 39 37 1 Determine the temperature of the Replacement fluid
  X X     Dialysate Temperature °C 30 39 37 1 Determine the temperature of the dialysate fluid
        X Plasma Temperature °C 30 39 37 1 Determine the temperature of the plasma exchanged
NOTE : “X”= parameter settable in the treatment
 
In order to modify the parameter value, press “value box” to enter in the following screen:

Insert the value using the keyboard or pressing the UP/Down arrows and confirm with OK button.
Press ABORT button to return to “HOMEPAGE” screen.

 
Start treatment
  
WARNING FOR THE OPERATOR. A BAD CONNECTION OF THE TUBINGS TO THE PATIENT COULD CAUSE A SEVERE BLOOD LEAKAGE.
  
After setting treatment parameters, press TREATMENT button to start the patient connection.
 
At the end of connection press TREATMENT button to enter in the treatment screen.
 
The warning “Blood pump stop” will immediately appear on the display.
 
Set the blood pump flow with the knob and press to confirm the value.
Start the pump pressing the button near the knob.
 
Press START button on the screen to activate the treatment.
 
Every time that STOP button is pressed, the blood pump still works, only the treatment is stopped.

 
Treatment data : main treatment data are displayed;
by pressing arrow button  all total treatment data will appear.:
 
 
Accumulation of fluid removal volume is measured directly as the weight difference between the fluid collected in the waste bag and the fluid remained in the replacement/dialysate bag.
 
Fluid removal flow rate is the average rate at which the fluid has been drawn from the patient. It is calculated as the ratio between the Accumulation of fluid removal volume and the treatment time.
 
PRESSURE: there are pressure bar graphs: the green area represent the ‘normal’ range, where limits of the normal range are limits for alarms. The red color represents the alarm area.
 
Select the underlined value on the single bargraphe to modify it; only the underlined values can be modified, (see table)
 
Arterial pressure Only Lower limit
Pre-filter pressure Only Upper limit
Venous pressure Range regarding the stable value
TMP pressure Only Upper limit
 
A small keyboard appears on the screen to set the values.



Menu
 
Pressing MENU button it is possible to select the following functions:
 
SETTINGS: it allows returning to the setting treatment screen, to change one or more treatment parameters
 
CHANGE SYRINGE: use this option to change the syringe when it is empty. it appears on the monitor the request of a confirm to change the syringe. By pressing YES, the device goes into a status where it waits for the operator to complete the operation. As asked on the screen, when the operation is complete, press OK.
 
CHANGE BAG: use this option to change one of the bags when it is needed. This option must be used either for replacement, for filtrate and for citrate bags. If citrate is chosen, a message will appear asking which bag has to be changed (Citrate or Replacement/Filtrate), otherwise only a request of confirmation will appear.
By choosing the bag (Citrate anticoagulant) or by giving confirmation (Heparine anticoagulant), the device goes into a status where it waits for the operator to complete the operation. As asked on the screen, when the operation is complete, press OK.
 
CHANGE TREATMENT: select a button regarding the new treatment, confirm it. Automatically the equipment will reset the totals and treatment setting screen will appear. Operator must verify treatment parameters and then proceed to start the new treatment by pressing the TREATMENT button
 
END TREATMENT: Use this item to end treatment before it reaches its target fluid removal. A request of confirmation will appear on the screen.
 

End treatment
 
Confirm the end of treatment to enter in the DISCONNECTION screen:
 

 
In order to disconnect the patient, follow the instruction that appear on the monitor; once done, press RESTITUTION button to start the restitution.
 
Turn on the blood pump to start the restitution.
 
When the restitution is complete, press END button and confirm to return to HOMEPAGE screen.
 
 
Power OFF the system
 
 
·         Press the standby button  to make the system in standby mode.
 
·         Press the main switch on the rear panel to get the “ OFF “ position.
 
If you need to disconnect the power supply cable, you must press the yellow button on it (see the following picture). The button is a part of the cable lock mechanism.

Lack of power alarm (device powered by battery)
 
Audible lack of power alarm and video alarm messages communicate that there is not power supply and the device is power by battery.
Moreover, when power supply is missing the venous line electroclamp closes and locks the venous access so as to prevent air inlet to the patient.
When there is again power supply it is possibile to go back to the previous page (before power supply interruption). This is possible up to the complete battery recharge.
When it is necessary to replace the battery, it is signalled by the SW, with a "exhausted battery" alarm which does not disappear during recharge time.
For the battery substitution you must contact the technical service of manufacturer.
 
 
Alarm system description
 
The device has two alarm categories:
·         HIGH PRIORITY – red colour – safety alarms
·         MEDIUM PRIORITY – yellow colour – warnings
 
Visual alarms are shown on User Interface screen in the specific dedicated area of the screen and at the same time in both the light indicators located on the left side and on the right side of the device (see the following picture).
Lights will blink on the machine in case of alarms and warnings; those lights will have red colors for safety alarm and yellow for warnings.
 

 
Two different kinds of acoustic alarm signals are emitted in case of alarms and warnings.
Acoustic alarm sound level: 85 dB sound level.
The volume of buzzer is not adjustable.
The sound level of high priority sound alarm signal is the same of medium priority sound alarm signal.
 
A list of possible causes and solutions can be brought into the user view as a troubleshooting help for the operator, by pressing the alarm message box.
A list of possible causes and solutions are illustrated into the user manual.
 
The operator can change the alarm range, the alarm upper limit or the alarm lower limit at a point in time, during the treatments for the following parameters:
·         Arterial pressure lower limit
·         Prefilter pressure upper limit
·         Transmembrane pressure upper limit
·         Venous pressure range limit.
 
An algorithmically determined ALARM LIMIT is the following:
·         Venous pressure upper and lower limits.
 
The OPERATOR-adjustable ALARM LIMITS are indicated continuously with the coloured bars:
·         Red for values out of limits
·         Green otherwise
 
The following picture indicates an indication example of OPERATOR-adjustable ALARM LIMITS.
 

 

 
 
User can reset an alarm, by pressing the alarm reset button:

 
If the cause of the alarm is not solved, the alarm will come out again immediately.
User can silence an error, by pressing the control for AUDIO PAUSED:
 
 
If silenced, the error is still shown, but the sound is stopped for 1 minute.
 
 
OPERATOR POSITION during the treatment:
·  If the operator operates on the device or on the patient, it is at the distance di about 50 cm from the device.
·  If the operator does not operate on the device or on the patient, it is on the room of the machine or at the distance that allows him to hear acoustic alarms and/or to see the visual alarms.
 
 
ALARM OVVERIDE MODE
The operator can deactivate the BLOOD LEAK detector completely or partially for unlimited time and a BLD alarm appears during all the time of BLD alarm override.
The operator can not override all the other alarms.
 
 
NOTE: after an alarm condition, contact the Service Department in case it is not possible to solve the problem and the error message continues to remain.
 

 
Safety alarm messages, causes and possible solutions
 
The safety alarms requires the immediate intervention of operator.
 
The following indications are intended as a guide to identify possible alarm causes and failure to operate by KIBOU. For each alarm situation there is listed a series of possible solutions.
 
The alarms messages and /or errors displayed on the display of KIBOU as listed below have as a consequence the stopping of the treatment.
 
The following picture illustrates an exemplum of safety allarm message.
 

 
 
The alarms descriptions are grouped by type of alarm.
 
 

 
 
SYSTEM safety alarms
 
Alarm Group Causes Solutions
 
 

Protective Cpu not running
SYSTEM Electronic anomaly: Protective Cpu is not running Try once to reset the alarm. If error persists, Contact Technical Service
Control Cpu not running SYSTEM Electronic anomaly: Control Cpu is not running Try once to reset the alarm. If error persists, Contact Technical Service
User Cpu  not running SYSTEM Electronic anomaly: User Cpu is not running Try once to reset the alarm. If error persists, Contact Technical Service
Weights Cpu not running SYSTEM Electronic anomaly: Weights Cpu is not running Try once to reset the alarm. If error persists, Contact Technical Service
Prs Cpu not running SYSTEM Electronic anomaly: Pressures Cpu is not running Try once to reset the alarm. If error persists, Contact Technical Service
Different arterial pressures SYSTEM Pressure values measured by Control and Protective systems does not match Calibrate pressure sensor
Different pre-filter pressures SYSTEM Pressure values measured by Control and Protective systems does not match Calibrate pressure sensor
Different venous pressures SYSTEM Pressure values measured by Control and Protective systems does not match Calibrate pressure sensor
Different UF pressures SYSTEM Pressure values measured by Control and Protective systems does not match Calibrate pressure sensor
Different Infusion weights SYSTEM Weight values measured by Control and Protective systems does not match Calibrate scales
Different UF weights SYSTEM Weight values measured by Control and Protective systems does not match Calibrate scales
Different Citrate weights SYSTEM Weight values measured by Control and Protective systems does not match Calibrate scales
Air test not working SYSTEM Bubble Detector automatic test has failed Interrupt the treatment and Contact technical service
BLD test not working SYSTEM Bubble Detector automatic test has failed Interrupt the treatment and Contact technical service
Data Error SYSTEM Internal data storage is corrupted Contact Technical Service
Calibration data error SYSTEM Calibration data storage is corrupted Contact Technical Service
Syringe pump relay test SYSTEM Syringe pump does not respond Contact Technical Service
Analog voltage SYSTEM Analog voltage is out of bounds Contact Technical Service
Battery voltage too low SYSTEM The battery charge is too low Connect Device to the power supply for at least ten hours
Battery Recharge Failure SYSTEM The battery is fully discharged and it is impossible recharged after many different attempts Contact technical service to substitute the battery
Temperature C-P different INF SYSTEM Temperature  values measured by Control and Protective systems does not match Contact Technical Service
Temperature C-P different DIA SYSTEM Temperature  values measured by Control and Protective systems does not match Contact Technical Service
Fatal Error SYSTEM Fatal Error generate by an unexpected software failure Contact Technical Service providing the ERROR CODE

 
 
 
SYRINGE safety alarms
 
Alarm Group Causes Solutions
 
 
Syringe is missing SYRINGE No siringe is placed in the syringe pump Place a syringe in the pump
Syringe lock is open SYRINGE The syringe lock is open or not properly closed Close the syringe lock or verify it be properly closed
Forbidden syringe size change SYRINGE The syringe size has been changed without a proper Syringe Change Procedure Starts a syringe change procedure or place back the previous syringe
Misplaced Syringe Plunger SYRINGE The syringe plunger is not properly inserted in its site Verify insertion of the plunger: push it firmly down
 
 

 
 
PRIMING safety alarms
 
Alarm Group Causes Solutions
 
 
Pressures not calibrated PRIMING Pressure domes (Access, Pre-filter or UF sensors) or venous blood catcher are not correctly mounted or are full of liquid Check each pressure connector be properly mounted
Pressures not calibrated PRIMING The sensor does not work Contact the technical service
Pressurization  Failed PRIMING The blood circuit is not hermetically closed (arterial line, venous lines, dialysate line, ultrafiltration line) Check all the caps of the luer lock connections
Pressurization  Failed PRIMING The tube of the venous line is not correctly inserted in the venous clamp holder Check the insertion of the tube and if necessary remount it
Pressurization  Failed PRIMING The venous pressure reading line is not properly connected or is full of liquid Check the connection of the line to the pressure connector
Excessive Venous Leakage PRIMING The blood circuit is not hermetically closed Check all the caps of the luer lock connections
Excessive Venous Leakage PRIMING The blood pump rotor needs to be calibrated Contact the technical service
Priming startup timeout PRIMING System could not move pump rotors in correct position Try again by resetting the alarm. If not successful, contact technical service
Wrong Filter Connection PRIMING The filter has been connected counter-current instead of co-current Revert filter connection
Scales test failed PRIMING Waste bag was not hanged to the ultrafiltrate scale Hang the waste bag to the ultrafiltrate scale
Scales test failed PRIMING Scales are not calibrated Contact technical service
 
 
 

 
ARTERIAL PRESSURE safety alarms
 
Alarm Group Causes Solutions
 
 
Minimum arterial pressure PRESSURES The alarm threshold is too high Decrease arterial alarm threshold
Minimum arterial pressure PRESSURES Obstruction present in the arterial blood circuit Check for the existence of some obstructions on the arterial extracorporeal circuit
Minimum arterial pressure PRESSURES There is an obstruction on the arterial pressure reading line Verify if the connection tube to the pressure transducer is closed by an external clamp or kinked or twisted
Minimum arterial pressure PRESSURES Blood pump setting is not suitable to the extracorporeal circuit, according to patient vascular access and needle size Verify if the blood flow is suitable for the extracorporeal circuit
Minimum arterial pressure PRESSURES Beginning of clotting inside the needles Verify that patient arterial access be not clotted
Arterial pressure lock PRESSURES There is an obstruction or a clamp on the arterial reading line Eliminate the obstruction or the clamp
Arterial pressure lock PRESSURES The arterial reading line is disconnected from the machine Connect the line to the machine
Maximum Arterial Pressure PRESSURES Probable mistake during the tubing set installation Verify the tubing set be mounted according to instructions on screen
Maximum Arterial Pressure PRESSURES Probable anomaly on the arterial pressure detector Contact Technical Service
Arterial pressure not zero PRESSURES The tubing set has been mounted before entering the Preparation screen Remove the domes from their holders, go back to treatment selection screen and enter again preparation screen
Arterial pressure not zero PRESSURES The sensor does not work Contact technical service
Arterial Pressure not connected PRESSURES Arterial pressure dome is not properly inserted and locked Verify dome be inserted and holder be locked (completely clockwise rotated)
Arterial Pressure not connected PRESSURES Dome holder malfunction Contact technical service
Arterial pressure not calibrated PRESSURES Arterial pressure not calibrated Perform a calibration of arterial pressure sensor
Arterial pressure data corrupted PRESSURES The arterial pressure calibration  values can not be read/written in EEPROM Contact technical service
Access Dome Open PRESSURES The Dome is not firmly closed Rotate dome holder knob clockwise holder until a click is felt
 

 
PRE-FILTER PRESSURE safety alarms
 
Alarm Group Causes Solutions
 
 
Minimum Pre-Filter Pressure PRESSURES The Pre-Filter pressure reading line is disconnected Connect the line
Minimum Pre-Filter Pressure PRESSURES There is a leakage on the arterial chamber Check all the connections placed on the tubes going to the arterial chamber including the connection of the infusion line on the blood circuit
Minimum Pre-Filter Pressure PRESSURES Anomaly on the Pre-Filter pressure detector Contact technical service
Pre-Filter pressure lock PRESSURES Blood pump speed could be too low to generate appreciable pressure variations Raise blood pump speed
Pre-Filter pressure lock PRESSURES An obstruction on the filter reading line is present. Remove the obstruction
Pre-Filter pressure lock PRESSURES The filter reading line is disconnected from the machine. Connect the line to the machine.
Maximum Pre-Filter pressure PRESSURES Presence of an obstruction on the Pre-filter pressure reading point Verify the presence of an obstruction and eliminate it
Maximum Pre-Filter pressure PRESSURES Pre-Filter pressure detector malfunction Contact technical service
Pre-Filter not zero PRESSURES The tubing set has been mounted before entering the Preparation screen Remove the domes from their holders, go back to treatment selection screen and enter again preparation screen
Pre-Filter not zero PRESSURES The sensor does not work Contact technical service
Pre-Filter pressure not connected PRESSURES Pre-Filter pressure dome is not properly inserted and locked Verify dome be inserted and holder be locked (completely clockwise rotated)
Pre-Filter pressure not connected PRESSURES Dome holder malfunction Contact technical service
Pre-Filter pressure not calibrated PRESSURES Pre-filter pressure not calibrated Perform a calibration of Pre-Filter pressure sensor
Pre-Filter pressure data corrupted PRESSURES Pre-filter pressure calibration values can not be read/written in EEPROM Contact technical service
Pre-Filter Dome Open PRESSURES The Dome is not firmly closed Rotate dome holder knob clockwise holder until a click is felt
 

 
 
VENOUS PRESSURE safety alarms
 
Alarm Group Causes Solutions
 
 
Minimum venous pressure PRESSURES Presence of a leakage in the extracorporeal circuit Verify the connections of the extracorporeal circuit
Minimum venous pressure PRESSURES The blood flow is not suitable for the extracorporeal circuit Verify the value of the blood pump flow
Minimum venous pressure PRESSURES The reading line has been disconnected Connect the line
Minimum venous pressure PRESSURES Anomaly on the Venous pressure detector Contact technical service
Venous pressure lock PRESSURES Blood pump speed could be too low to generate appreciable pressure variations Raise blood pump speed
Venous pressure lock PRESSURES An obstruction on the filter reading line is present. Remove the obstruction
Venous pressure lock PRESSURES The filter reading line is disconnected from the machine. Connect the line to the machine.
Maximum Venous Pressure PRESSURES Obstruction present in the venous blood circuit Check for the existence of some closure on the venous extracorporeal circuit
Maximum Venous Pressure PRESSURES Presence of some obstruction on the venous pressure reading line Verify that the connection tube to the venous pressure transducer is not closed by an external clamp or twisted on its own and if necessary solve the problem
Maximum Venous Pressure PRESSURES The blood pump flow is not suitable to  the extracorporeal circuit Verify if the blood flow is suitable  for the extracorporeal circuit
Maximum Venous Pressure PRESSURES Beginning of clotting inside the needles Verify whether the patients venous access is clotting free
Venous pressure not calibrated PRESSURES Venous pressure not calibrated Perform a calibration of venous pressure sensor
Venous pressure data corrupted PRESSURES Venous pressure calibration  values can not be read/written in EEPROM Contact technical service
Venous pressure not zero PRESSURES The tubing set has been mounted before entering the Preparation screen Remove the domes from their holders, go back to treatment selection screen and enter again preparation screen
Venous pressure not zero PRESSURES The sensor does not work Contact technical service

 
 
ULTRAFILTRATION PRESSURE safety alarms
 
Alarm Group Causes Solutions
 
 
Minimum Ultrafiltration Pressure PRESSURES The ultrafiltration pressure reading line was disconnected Connect the line
Minimum Ultrafiltration Pressure PRESSURES Anomaly on the ultrafiltration pressure detector Contact technical service
Ultrafiltration pressure lock PRESSURES Blood pump speed could be too low to generate appreciable pressure variations Raise blood pump speed
Ultrafiltration pressure lock PRESSURES An obstruction on the ultrafiltration reading line is present. Remove the obstruction
Ultrafiltration pressure lock PRESSURES The ultrafiltration reading line, is disconnected from the machine. Connect the line to the machine.
Maximum Ultrafiltration pressure PRESSURES Presence of an obstruction on the ultrafiltration pressure reading point Verify the presence of an obstruction and eliminate it
Maximum Ultrafiltration pressure PRESSURES Ultrafiltration pressure detector malfunction Contact technical service
Ultrafiltration Pressure  Not Zero PRESSURES The tubing set has been mounted before entering the Preparation screen Remove the domes from their holders, go back to treatment selection screen and enter again preparation screen
Ultrafiltration Pressure  Not Zero PRESSURES The sensor does not work Contact technical service
Ultrafiltration Pressure dome not connected PRESSURES Ultrafiltration pressure dome is not properly inserted and locked Verify dome be inserted and holder be locked (completely clockwise rotated)
Ultrafiltration Pressure dome not connected PRESSURES Dome holder malfunction Contact technical service
Ultrafiltration pressure not calibrated PRESSURES Ultrafiltration pressure not calibrated Perform a calibration of UF pressure sensor
Ultrafiltration pressure data corrupted PRESSURES Ultrafiltration pressure calibration values can not be read/written in EEPROM Contact technical service
UF Dome Open PRESSURES The Dome is not firmly closed Rotate dome holder knob clockwise holder until a click is felt
 

 
 
DROP PRESSURE safety alarms
 
Alarm Group Causes Solutions
 
 
Maximum Drop Pressure PRESSURES An obstruction on the pre-filter line is present Remove the obstruction on the pre-filter arterial line
Maximum Drop Pressure PRESSURES An obstruction on the venous line is present Remove the obstruction on the venous line
Maximum Drop Pressure PRESSURES Filter is clotted Replace the cartridge and the filter
 
 
Drop_Pressure = Prefilter_pressure – Venous_pressure
 
 
 
 
TMP PRESSURE safety alarms
 
Alarm Group Causes Solutions
 
 
Maximum TMP Pressure PRESSURES An obstruction on the pre-filter line is present Remove the obstruction on the pre-filter arterial line
Maximum TMP Pressure PRESSURES An obstruction on the venous line is present Remove the obstruction on the venous line
Maximum TMP Pressure PRESSURES An obstruction on the ultrafiltration line is present Remove the obstruction on the ultrafiltration line
Maximum TMP Pressure PRESSURES Filter is clotted Replace the cartridge and the filter
 
 
TMP_Pressure = [(Prefilter_pressure + Venous_pressure)/2] – Ultrafiltrate_pressure
 
 
 
 

 
 
BALANCES safety alarms
 
Alarm Group Causes Solutions
 
 
Infusion weight not zero BALANCES A bag or a weight has been hanged to the infusion scale hook before entering Preparation screen Reset the alarm and proceed normally
Infusion weight not zero BALANCES Scale not calibrated Calibrate the scale
Infusion weight not zero BALANCES Scale malfunction Contact technical service
Infusion scale not calibrated BALANCES The scale is not calibrated properly Calibrate the scale
Infusion scale  data corrupted BALANCES Infusion scale calibration values can not be read/written in EEPROM Contact technical service
Infusion scale disconnected BALANCES The load scale connector is disconnected Contact technical service
Infusion scale disconnected BALANCES The load scale does not work Contact technical service
Excessive Infusion Weight BALANCES An excessive weight was hanged to the scale Remove the weight or limit it
Infusion Weight Variation BALANCES During treatment a bag was removed incorrectly Hang the bag again and reset alarm
Infusion Weight Variation BALANCES The fluid bag is not stable Make the bag stable
Infusion Weight Variation BALANCES There is an heavy leakage from the substitution circuit (bag, tubing set…) Eliminate the leakage and if necessary replace the tubing set
Infusion Weight Variation BALANCES There is an obstruction on the replacement or dialysate circuit (bag, tubing set…) Eliminate the obstruction
Ultrafiltration weight not zero BALANCES A bag or a weight has been hanged to the UF scale hook before entering Preparation screen Reset the alarm and proceed normally
Ultrafiltration weight not zero BALANCES Scale not calibrated Calibrate the scale
Ultrafiltration weight not zero BALANCES Scale malfunction Contact technical service
Ultrafiltration scale not calibrated BALANCES The scale is not calibrated properly Calibrate the scale
Ultrafiltration scale  data corrupted BALANCES Ultrafiltration scale calibration values can not be read/written in EEPROM Contact technical service
Ultrafiltration scale disconnected BALANCES The load scale connector is disconnected Contact technical service
Ultrafiltration scale disconnected BALANCES The load scale does not work Contact technical service
Excessive Ultrafiltration Weight BALANCES An excessive weight was hanged to the scale Remove the weight or limit it
Ultrafiltration Weight Variation BALANCES A bag was removed incorrectly Hang the bag again and reset alarm
Ultrafiltration Weight Variation BALANCES The bag is not stable Make the bag stable
Citrate weight not zero BALANCES A bag or a weight has been hanged to the Citrate scale hook before entering Preparation screen Reset the alarm and proceed normally
Citrate weight not zero BALANCES Scale not calibrated Calibrate the scale
Citrate weight not zero BALANCES Scale malfunction Contact technical service
Citrate scale not calibrated BALANCES The scale is not calibrated properly Calibrate the scale
Citrate scale  data corrupted BALANCES Citrate scale calibration values can not be read/written in EEPROM Contact technical service
Citrate scale disconnected BALANCES The load scale connector is disconnected Contact technical service
Citrate scale disconnected BALANCES The load scale does not work Contact technical service
Excessive Citrate Weight BALANCES An excessive weight was hanged to the scale Remove the weight or limit it
Citrate Weight Variation BALANCES A bag was removed incorrectly Hang the bag again and reset alarm
Citrate Weight Variation BALANCES The bag is not stable Make the bag stable
Infusion Bag Empty BALANCES Infusion Bag is empty Verify Infusion bag and eventually replace it by the appropriate procedure
UF Bag Full BALANCES UF Bag is Full Verify UF bag and eventually replace it by the appropriate procedure
Citrate Bag Empty BALANCES Citrate Bag Empty Replace Citrate Bag

 
 
BUBBLE DETECTOR safety alarms
 
Alarm Group Causes Solutions
 
 
Air Alarm not detected BUBBLE DETECTOR The tubing set has been mounted before entering the Preparation screen Reset the alarm and proceed normally
Air Alarm not detected BUBBLE DETECTOR The sensor does not work Contact technical service
Air in venous line BUBBLE DETECTOR Air has been detected inside the venous line Push manually  the safety clamp and raise level in the venous chamber to bring bubbles back to the venous chamber.
Air in venous line BUBBLE DETECTOR The tube controlled by air sensor is out of place Place correctly the tube into the air sensor
Air in venous line BUBBLE DETECTOR The detector does not work Contact technical service
Air test absent BUBBLE DETECTOR The continuous test of the air sensor was not successful Contact technical service
Air test failed BUBBLE DETECTOR The continuous test of the air sensor was not successful Contact technical service

 
 
BLD - BLOOD LEAKAGE DETECTOR safety alarms
 
Alarm Group Causes Solutions
 
 
Tube inserted in the BLD sensor BLD The tubing set has been mounted before entering the Preparation screen Reset the alarm and proceed normally
Tube inserted in the BLD sensor BLD The BLD sensor is subjected to an excessive light If tube is not inserted in the BLD, contact the technical service
Tube inserted in the BLD sensor BLD The sensor does not work If tube is not inserted in the BLD, contact the technical service
Blood leakage BLD Air in the tube controlled by BLD sensor alter the sensor reading Press softly the U.F. tube on the top of the BLD sensor, to allow the air bubbles to go inside the U.F. bag
Blood leakage BLD Presence of leakages into the membranes of the hemofilter Replace the tubing set  and the  filter
Blood leakage BLD The sensor does not work Contact technical service
Excessive room light BLD The tube controlled by the BLD sensor is exposed to a very powerful light source Limit the room light
Excessive room light BLD The tube part controlled by the BLD sensor is out of its site Remount correctly the tube within the BLD sensor
Tube not inserted in the BLD sensor BLD The tube is not inserted properly inside the BLD sensor Insert the tube inside the BLD properly
Tube not inserted in the BLD sensor BLD Presence of air in the tube inserted in the BLD Press softly the U.F. tube on the top of the BLD sensor, to allow the air bubbles to go inside the U.F. bag
Tube not inserted in the BLD sensor BLD The presence sensor does not work Contact technical service
BLD test failed BLD The continuous test of the BLD sensor was not  successful Contact technical service
BLD test absent BLD The continuous test of the BLD sensor was not positively successful Contact technical service
BLD tx over-range BLD Electronic anomaly Contact technical service
BLD data corrupted BLD The bled calibration  values can not be read/written in on chip RAM Contact technical service

 
 
LEVEL DETECTOR safety alarms
 
Alarm Group Causes Solutions
 
 
Level test failed LEVEL DETECTOR The continuous test of the level sensor was not successful Contact technical service
Level test absent! LEVEL DETECTOR The continuous test of the level sensor was not successful Contact technical service
Low level adjustment failed LEVEL DETECTOR Adjustment of low level in venous chamber failed Wait or contact technical service
High level adjustment failed LEVEL DETECTOR Adjustment of high level in venous chamber failed Wait or contact technical service
 
 
LINE SELECTOR safety alarms
 
Alarm Group Causes Solutions
 
 
Line selector driver fault LINE SELECTOR Anomaly on the line selector command system Contact technical service
Line selector not closed LINE SELECTOR The line selector is not closed Contact technical service
Line selector not opened LINE SELECTOR The line selector is not properly open Contact technical service
 

 
 
HEATER safety alarms
 
Alarm Group Causes Solutions
 
 
Temp inf data corrupted HEATER The infusion temperature calibration values can not be read/written in on chip RAM Contact technical service
Temp dial data corrupted HEATER The dialysate temperature calibration  values can not be read/written in on chip RAM Contact technical service
High Temperature INF. HEATER The temperature of the infusion heating plate raised above the maximum acceptable value Contact technical service
High Temperature DIA. HEATER The temperature of the dialysate heating plate raised above the maximum acceptable value Contact technical service
Heater INF relay fault HEATER An anomaly on the infusion heater power supply circuit has been detected during the test Contact technical service
Heater DIA relay fault HEATER An anomaly on the dialysate heater power supply circuit has been detected during the test Contact technical service
Low Infusion temperature HEATER Temperature in infusion heater is too low Wait or contact technical service
High Infusion temperature HEATER Temperature in infusion heater is too high Wait or contact technical service
Low Dialysate temperature HEATER Temperature in dialysate heater is too low Wait or contact technical service
High Dialysate temperature HEATER Temperature in dialysate heater is too high Wait or contact technical service

 
 
CLAMP safety alarms
 
Alarm Group Causes Solutions
 
 
Clamp relay fault CLAMP An anomaly on the clamp power supply circuit has been detected during the test Contact technical service
Clamp driver fault CLAMP Anomaly on the safety clamp command system Contact technical service
Clamp not closed CLAMP The venous clamp is not closed Contact technical service
Clamp not opened CLAMP The venous clamp is not properly open Contact technical service
 
 
 
BLOOD PUMP safety alarms
 
Alarm Group Causes Solutions
 
 
Blood pump door opened PUMPS The pump cover is open Close the cover
Blood pump door opened PUMPS The pump rotor is not properly fixed Tight the rotor screw completely
Blood pump door opened PUMPS The cover sensor is out of its place Contact technical service
Blood pump relay fault PUMPS An anomaly on the blood pump power supply circuit has been detected during the test Contact technical service
Blood pump driver fault PUMPS Anomaly in the blood pump command system Contact technical service
Blood pump speed error PUMPS Anomaly on the blood pump command system Contact technical service
Blood pump not stopped PUMPS Anomaly on the blood pump command system Contact technical service
Blood pump not running PUMPS The Blood pump  is not rotating while it should Contact technical service
Blood Pump Stopped PUMPS The Blood pump has not been activated Activate blood pump
 
 

 
 
INFUSION PUMP safety alarms
 
Alarm Group Causes Solutions
 
 
Infusion pump door opened PUMPS The pump cover is open Close the cover
Infusion pump door opened PUMPS The pump rotor is not properly fixed Tight the rotor screw completely
Infusion pump door opened PUMPS The cover sensor is out of its place Contact technical service
Infusion pump door opened PUMPS The sensor does not work Contact technical service
Infusion pump relay fault PUMPS An anomaly on the infusion pump power supply circuit has been detected during the test Contact technical service
Infusion pump driver fault PUMPS Anomaly on the infusion pump command system Contact technical service
Infusion pump speed error PUMPS Anomaly on the infusion pump command system Contact technical service
Infusion pump not stopped PUMPS Anomaly on the infusion pump command system Contact technical service
Infusion pump not running PUMPS The infusion  pump is not rotating while it should Contact technical service
 
 
 

 
 
DYALYSATE PUMP safety alarms
 
Alarm Group Causes Solutions
 
 
Dialysate pump door opened PUMPS The pump cover is open Close the cover
Dialysate pump door opened PUMPS The pump rotor is not properly fixed Tight the rotor screw completely
Dialysate pump door opened PUMPS The cover sensor is out of its place Contact technical service
Dialysate pump door opened PUMPS The sensor does not work Contact technical service
Dialysate pump relay fault PUMPS An anomaly on the Dialysate pump power supply circuit has been detected during the test Contact technical service
Dialysate pump driver fault PUMPS Anomaly on the Dialysate pump command system Contact technical service
Dialysate pump speed error PUMPS Anomaly on the Dialysate pump command system Contact technical service
Dialysate pump not stopped PUMPS Anomaly on the Dialysate pump command system Contact technical service
Dialysate pump not running PUMPS The Dialysate pump is not rotating while it should Contact technical service
 

 
 
CITRATE PUMP safety alarms
 
Alarm Group Causes Solutions
 
 
Citrate pump door opened PUMPS The pump cover is open Close the cover
Citrate pump door opened PUMPS The pump rotor is not properly fixed Tight the rotor screw completely
Citrate pump door opened PUMPS The cover sensor is out of its place Contact technical service
Citrate pump door opened PUMPS The sensor does not work Contact technical service
Citrate pump relay fault PUMPS An anomaly on the citrate pump power supply circuit has been detected during the test Contact technical service
Citrate pump driver fault PUMPS Anomaly in the net citrate pump command system Contact technical service
Citrate pump speed error PUMPS Anomaly on the citrate pump command system Contact technical service
Citrate pump not stopped PUMPS Anomaly on the citrate pump command system Contact technical service
Citrate pump not running PUMPS The Citrate pump is not rotating while it should Contact technical service

 
 
ULTRAFILTRATION PUMP safety alarms
 
Alarm Group Causes Solutions
 
 
Ultrafiltration pump door opened PUMPS The pump cover is open Close the cover
Ultrafiltration pump door opened PUMPS The pump rotor is not properly fixed Tight the rotor screw completely
Ultrafiltration pump door opened PUMPS The cover sensor is out of its place Contact technical service
Ultrafiltration pump door opened PUMPS The sensor does not work Contact technical service
Ultrafiltrate pump relay fault PUMPS An anomaly on the Ultrafiltrate pump power supply circuit has been detected during the test Contact technical service
Ultrafiltrate pump driver fault PUMPS Anomaly in the Ultrafiltrate pump command system Contact technical service
Ultrafiltrate pump speed error PUMPS Anomaly on the Ultrafiltrate pump command system Contact technical service
Ultrafiltrate pump not stopped PUMPS Anomaly on the Ultrafiltrate pump command system Contact technical service
Ultrafiltrate pump not running PUMPS The ultrafiltrate pump is not rotating while it should Contact technical service

 
 
SYRINGE PUMP safety alarms
 
Alarm Group Causes Solutions
 
 
Syringe pump overload PUMPS Presence of an obstruction on the anticoagulant line Remove the obstruction on the line
Syringe pump overload PUMPS There is an excessive pressure inside the extracorporeal circuit Verify that the blood flow is adequate for the extracorporeal circuit
Syringe pump overload PUMPS The sensor does not work Contact technical service
Syringe pump motor lock PUMPS Anomaly of the motors which manages the anticoagulant pump motor Contact technical service
Syringe pump relay fault PUMPS An anomaly on the Heparin pump power supply circuit has been detected during the test Contact technical service
Syringe pump driver fault PUMPS Anomaly in the Heparin pump command system Contact technical service
Syringe Empty PUMPS Syringe is empty Verify Syringe and eventually reload it
 
 
POWER MONITOR safety alarms
 
Alarm Group Causes Solutions
 
 
Power voltage monitor data corrupted POWER MONITOR The power voltages monitor  calibration  values can not be read/written in on chip RAM Contact technical service
 

 
FLOW/WEIGHT safety alarms
 
Alarm Group Causes Solutions
 
 
Flow/weight dialysate does not match PUMPS Leakage from Infusion bags Verify the infusion bag and eventually change it
Flow/weight dialysate does not match PUMPS Tube is not properly inserted inside the dialysate pump Verify insertion of the tube inside the pump
Flow/weight dialysate does not match PUMPS Dialysate Pump Rotor not calibrated Contact technical service
Flow/weight Infusion does not match PUMPS Leakage from Infusion bags Verify the infusion bag and eventually change it
Flow/weight Infusion does not match PUMPS Tube is not properly inserted inside the infusion pump Verify insertion of the tube inside the pump
Flow/weight Infusion does not match PUMPS Infusion Pump Rotor not calibrated Contact technical service
Flow/weight UF does not match PUMPS Leakage from ultrafiltrate bags Verify the ultrafiltrate bag and eventually change it
Flow/weight UF does not match PUMPS Tube is not properly inserted inside the UF pump Verify insertion of the tube inside the pump
Flow/weight UF does not match PUMPS Infusion Pump Rotor not calibrated Contact technical service
UF Variance TREATMENT Weight variance exceeded safety limit Wait while system recovers balance
Infusion Variance TREATMENT Weight variance exceeded safety limit Wait while system recovers balance
 
 

 
 
Warnings messages, causes and possible solutions
 
The warning messages requires the prompt intervention of operator.
 
The following indications are intended as a guide to identify possible alarm causes and failure to operate by KIBOU. For each alarm situation there is listed a series of possible solutions.
KIBOU displays all the alarms in the appropriate alarm row.
 
The alarms messages and /or errors displayed on the display of KIBOU as listed below have as a consequence the stopping of the treatment and the machine.
 
NOTE: Contact the Service Department in case it is not possible to solve the problem and the error message continues to remain.
 
The following picture illustrates an exemplum of warning message.
 

 

 
Alarm Group Causes Solutions
 
 
Treatment Parameters Out Of Range TREATMENT Treatment parameters are out of range Check treatment parameters
User Interface Warning SYSTEM User interface raised a warning  
Warning: BLD Alarm Override BLD BLD Alarm is temporarily overridden BLD Alarm has been overridden by operator. It will recover its status automatically
Warning: Blood Pump Stopped PUMPS Blood pump is not operating during treatment Turn pump on
Warning: the treatment was stopped too long      
Warning: Treatment Completed TREATMENT Treatment has been completed Start a new treatment or proceed to blood restitution
Warning: Priming Completed PRIMING Priming has been completed Proceed to treatment
 
 
 

 
Labels explanation

Front panel symbol explanation
 
The DMA bears the following front panel labels.
  
Follows an explanations of the symbols upon the front panel label.
 
Symbols Explanation

 
Standby on/off button and standby state led indication. After the power on with the ON/OFF button on the rear panel, the led becames green and the device is in standby mode. During this state the main CPU board is power off but the battery is on charge. The operator must press the standby on/off key
 
to power on/off the CPU, display and user interface. After that the led is power off.

 
Blood pump ON/OFF key. By pressing this key the operator can start/stop the blood infusion pump.

 
Blood pump speed regulation. By rotating this knob the operator can regulate the blood infusion pump speed.
 
 
Packaging symbols explanation
 
The following table indicates the DMA packaging labels and symbols explanation.
 
Symbols Explanation
  Fragile, handle with care.
  Keep dry.
  Indicate the temperature limits to which the packed medical device can be safely exposed.
 
Input/Output ports functions and labelling
 
The device has the following input/output ports:
·         LAN: not used.
·         USB: the port can be connected to a keyboard, mouse or a memory USB key to allow the upgrade of the device software. This port can be used only by the service personnel during the device service. CAUTION! Don’t connect this port during treatment.
·         COM: not used.
 
Label, function and use of the Potenzial Equalization Conductor
 
The ME EQUIPMENT is provided with a terminal for the connection of a Potenzial Equalization Conductor with the following features:
·         the terminal is accessible to the OPERATOR with the ME EQUIPMENT in any position of NORMAL USE;
·         the terminal allows the conductor to be detached without the use of a TOOL;
·         the terminal is marked with the following symbol.

 
The terminal shall not be used for a PROTECTIVE EARTH CONNECTION.
 
Function and use of the POTENTIAL EQUALIZATION CONDUCTOR:
·         in case of the use of more than one active medical device on the same patient, the operator must connect together all the terminals of the Potenzial Equalization Conductors of the active medical devices.
 
Technical features and performance
 
 
Description
  KIBOU is a machine for Continuous Renal Replacement Treatments
 
 
Supported treatments
  SCUF, CVVH, CVVHD, CVVHDF and TPE
 
 
Power supplyinput
 
·         Voltage input: 230 VAC
·         Power input: 460 VA
·         Frequency input: 50 Hz
 
 
Power input protective device
 
Automatic circuit breaker.
 
 
 
Anticoagulation modes
  Supports both heparin and citrate.
 
 
European/International Standards
 
  • EN IEC 60601-1
  • EN IEC 60601-2-16
  • EN IEC 60601-1-2
 
 
European directive MDD 93/42 and subsequent amendments classification
  Class IIb.
 
 
 
IEC 60601-1 classification
       
  • Electrical safety classification: Class I type B.
  • Device is not intended for the use in oxigen rich envinronments.
  • The device is classified for continuous operation mode.
 
 
IP Code (as per EN IEC 60529 Standard)
       
Degree of protection provided by enclosure: IP 30
 
 
 
Battery
       
A rechargeable battery is present to provide 15min. backup.
Contact technical service to substitute the battery.
 
Input/Output ports
       
·           Ethernet (not used);
·           USB (for service only);
·           RS232 (not used).
 
 
Envinronment
       
Installation and operating envinronment:
·           Ambient temperature 15 to 35 °C
·           Relative humidity 35 to 75 % (No condensation)
·           Atmospheric pressure 70 to 106 kPa
·           Avoid direct exposure to sunlight
Transportation Environment:
·           Ambient temperature -10 to 50 °C
·           Relative humidity 35 to 85 % (No condensation)
·           Atmospheric pressure 50 to 106 kPa
Storage Environment:
·           Ambient temperature -10 to 40 °C
·           Relative humidity 35 to 85 % (No condensation)
·           Atmospheric pressure 50 to 106 kPa
 
 
Warranty
       
The warranty period shall be two (2) years from installation date at customer place.
 
Life Time
       
Life time is 10 years.
 
Stand-By mode
       
Machine will have a stand-by mode, where main switch is on and battery is recharging, but all other subsystems are powered off
 
Blood Pump
       
·           Flow rate: 1 to 400 mL/min
·           Increments: 1mL/min (at 1 to 30 mL/min); 5mL/min (at 30 to 400 mL/min)
·           Accuracy: < ± 10%
·           Suction Pressure: < -40 kPa
·           Discharge Pressure: > 98.1 kPa
 
 
Filtrate Pump
       
·           Flow rate: 10 to 12000 mL/h
·           Increment: 10 mL/h
·           Accuracy: < ±10% at suction pressure -100 to 100 mmHg
·           Suction pressure: < -40kPa
·           Discharge pressure: > 98.1kPa
 
 
Dialysate Pump
       
·           Flow rate: 10 to 10000 mL/h
·           Increment: 10 mL/h
·           Accuracy: < ±10% at suction pressure -100 to 100 mmHg
·           Suction pressure: < -40kPa
·           Discharge pressure: > 98.1kPa
 
 
Replacement Fluid Pump
       
·           Flow rate: 10 to 10000 mL/h
·           Increment: 10 mL/h
·           Accuracy: < ±10% at suction pressure -100 to 100 mmHg
·           Suction pressure: < -40kPa
·           Discharge pressure: > 98.1kPa
 
 
Syringe Pump
       
·           Flow rate: 0.1 to 15.0 mL/h
·           Accuracy: < 0.2 mL/h of displayed value of 5.0 mL/h
·           Applicable syringe: 20, 30 and 50 mL disposable syringe.
·           Overload alarm pressure: 40 to 140 kPa (Adjusted in hardware)
·           Fast feed flow rate: > 0.1mL/sec
Functions:
·           Size detection,
·           plunger detection,
·           end notice detection,
·           motion detection,
·           Occlusion detection (0.2cc threshold)
·           Bolus Delivery
 
 
Citrate Pump
       
·           Flow rate: 1 to 600 mL/h
·           Accuracy: < ±1% with flow rate control system
·           Suction pressure: < -40kPa
·           Discharge pressure: > 98.1kPa
 
 
 
 
 
 
Citrate Scale

 

     
Full Scale: 2Kg;
Accuracy:
± 0.5% F.S. in the Controller Channel;
± 10% F.S. in the Protective channel;
Sensitivity: 1g
Max. Overload: 30Kg
 
 
 
Fluid Removal Control System
       
·           Max Load: 15Kg of replacement fluid.
·           Overall precision of weight loss: +/- 0.3% with respect to total treatment fluid (i.e. 150mL over 50L )
·           Separate measurement of replacement fluid and filtrate.
 
 
Infusion Scale

 

     
Full Scale: 15Kg;
Accuracy:
± 0.1% F.S. in the Controller Channel;
± 0.1% F.S. in the Protective channel;
Sensitivity: 1g
Max. Overload: 30Kg
 
Filtrate scale

 

     
Full Scale: 15Kg;
Accuracy:
± 0.1% F.S. in the Controller Channel;
± 0.1% F.S. in the Protective channel;
Sensitivity: 1g
Max. Overload: 30Kg
 
 
Air Detector
       
·           Sensitivity: > 0.01 mL (at flow rate of 100 mL/min)
 
 
 
Heaters
       
·           There are two separate heaters for pre and post dilution
·           Heaters redundancy safety working: each heater has two separate temperature sensors, the one conneted to control microprocessor and the other to protection microprocessor.
·           Able to heat at 36° at a flow rate of 150 ml/min.
·           Infusion liquid temperature selectable range: 30°C-39°C
·           Inlet fluid temperature 20±2.
·           Room temperature 25±2.
·           Temperature range of heater plate: from 20 to 55°C
·           Controlled temperature range during treatment of heater plate:
from 40 to 55°C
·         Internal temperature sensor range: from 0 to 100 °C
·         Internal temperature sensor resolution: 0.1 °C
·         Internal temperature sensor accuracy: ± 2% F.S.
 
 
 
Clamp on venous line
       
·           Close pressure: > 98.1 kPa
 
 
Blood Leak Detector
       
·           Sensitivity: > blood cell concentration 0.15 %,
sensitivity can be decreased: 100%-90%-80%-70%-60%-50% 0(Off).
 
Inlet Pressure Monitor
       
·           Range :-66.7 kPa to 66.7 kPa
·           Accuracy: < ±15 mmHg at the displayed value of -300 or 300 mmHg; < ±4 mmHg at the displayed value of 0mmHg
·           Remark: No calibration for 72 hours.
·           Sensor to detect incorrect closure.
 
 
Venous pressure monitor
       
·           Range: -66.7 kPa to 66.7 kPa
·           Accuracy: < ±15 mmHg at the displayed value of -300 or 300 mmHg; < ±4 mmHg at the displayed value of 0mmHg
 
 
Filtrate Pressure Monitor
       
·           Range: -66.7 kPa to 66.7 kPa
·           Accuracy: < ±15 mmHg at the displayed value of -300 or 300 mmHg; < ±4 mmHg at the displayed value of 0mmHg.
·           Sensor to detect incorrect closure.
 
 
Arterial Pressure Monitor
       
·           Range: -66.7 kPa to 66.7 kPa
·           Accuracy: < ±15 mmHg at the displayed value of -300 or 300 mmHg; < ±4 mmHg at the displayed value of 0mmHg
·           Remark: No calibration for 72 hours.
·           Sensor to detect incorrect closure.
 
 
 
For further information or advice about the use of the equipment, the maintenance or the technical assistance contact the local distributor, or
 
  MEDICA S.p.A.
Via Degli Artigiani, 7
41036 MEDOLLA
MODENA - ITALY
Tel. +39 (0)535 51159
Fax +39 (0)535 52605
 e-mail: info@medica.it
home page: www.medica.it
 
 
 

 
Electromagnetic compatibility warnings
 
KIBOU is manufactured in compliance with the directives CEI EN 60601-1-2 (2010) regarding the Electromagnetic Compatibility   (EMC) of the medical equipment.
KIBOU requires cautions in this concern and must be installed and operated in conformity with the following instructions as per the ECM directives.
Portable and mobile RF communication equipment can affect this MEDICAL ELECTRICAL EQUIPMENT.
The KIBOU is intended for use in the electromagnetic environment specified the tables below. The user of the KIBOU should make sure that it is used in such an environment.
For Electromagnetic Compatibility reason KIBOU must be used only with the following accessory:
·         Main power supply cable VOLEX mod. VL-1024-23-200.
Warning: the use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the ME EQUIPMENT or ME SYSTEM as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM
 
Tab. 1  Guidance and manufacturer’s declaration – electromagnetic emissions
KIBOU is intended for use in the electromagnetic environment specified below. The customer or the user of the KIBOU should make sure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The KIBOU uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B  
Harmonic emissions
IEC 61000-3-2
Class A  
Voltage fluctuation / flicker emissions
IEC 61000-3-3
Complies  
 

 
Tab. 2  Guidance and manufacturer’s declaration – electromagnetic immunity
KIBOU is intended for use in the electromagnetic environment specified below. The customer or the user of the KIBOU should make sure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV air
-
±6 kV contact
±8 kV air, level 3 -
±6 kV contact, level 2
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
±2 kV common mode -
±1 kV differential mode
±2 kV common mode -
±1 kV differential mode
Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential mode -
±2 kV common mode
±1 kV differential mode -
±2 kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage droops short interruptions and voltage variations on power supply input lines
 
IEC 61000-4-11
<5%U(>95% droop in UT) for 0.5 cycles .
40%U(60% droop in UT) for 5 cycles

70%U(30% droop in UT) for 25 cycles –
<5%U(95% droop in UT) for 5 sec
<5%U(>95% droop in UT) for 0,5 cycles
-
40%U(60% droop in UT) for 5 cycles

70%U(30% droop in UT) for 25 cycles
 –
<5%U(95% droop in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment.
If the user of the KIBOU requires continued operation during power mains interruptions, it is recommended that the KIBOU be powered from an uninterruptible power supply.
Power frequency  (50/60 Hz)
Magnetic field at mains frequency (50 Hz)
IEC 61000-4-8
3 A/m  3 A/m Mains power quality should be that of a typical commercial or hospital environment.
 

 
Tab. 4  Guidance and manufacturer’s declaration – radio frequency
KIBOU is intended for use in the electromagnetic environment specified below. The customer or the user of the KIBOU should make sure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance (distance of the transmitter from KIBOU)
Conducted RF 3 Veff 3 Veff d = 1.17 √P.
Where P is the maximum nominal power of the transmitter in Watt and d is the distance in meters
Irradiated RF 10 V/m
(26 MHz  -1GHz)
…………..
3 V/m
 (1GHz –2.5GHz)
10 V/m
 
3 V/m
d = 0.35 √P  from 80 MHz to 800 MHz
d = 0.70 √P  from 800 MHz to 1 GHz
d = 2.33√P  from  1GHz to 2.5 GHz
Where P is the maximum nominal power of the transmitter in Watt and d is the distance in meters
 
Tab. 6  Guidance and manufacturer’s declaration – radio frequency
KIBOU is intended for use in the electromagnetic environment where irradiated disturbances originated by radio equipment are under control. The operator of the KIBOU can help in preventing interferences making sure that a minimum distance be kept between KIBOU and mobile phones (RF transmitters) as per the below table.
Maximum power of emission of the transmitter in Watt Recommended minimum distance of the transmitter from KIBOU in meters
  From 15 KHz to 80 MHz From 80 MHz to 800 MHz From 800 MHz to 1 GHz From 1GHz to 2.5 GHz
0.01 0.12 0.04 0.07 0.23
0.1 0.37 0.11 0.22 0.74
1 1.17 0.35 0.70 2.33
10 3.69 1.11 2.21 7.38
100 11.67 3.50 7.00 23.33
 

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