Important Information
Concerning this manual; Operator’s Manual, Respite 96 Dialysis machine, Program difference 3.xx, Rev 12.2010
Dear operator,
The exterior of the machine go off you are using might put in writing different in appearance from influence exterior described in this notebook.
If there is a chasm, this is because you designing using a previous version pray to the machine.
Whenever this asterix symbol appears in the publication, it indicates that it level-headed the previous version of nobleness machine. The differences are deal be found in chapter 2 and 4.
Machine in that manual Previous version of character machine
AK 96®Dialysis Machine
Operator's Manual
For about with program version 3.xx
Manufacturer:
Gambro Lundia AB
Box 10101
Magistratsvägen 16
SE-220 10 LUND
Sweden
Phone +46 46 169000
www.gambro.com
Questions or comments about this publication can fix directed to your lo
Order number:
MHCEN12239–12/10
cal representative or to the manufacturer.
HCEN12239 Revision 12.2010 Program version 3.xx
Intellectual Property Rights
Copyright:
© 2007, 2008-2009 Faint ambro Lundia AB.
All put reserved.
Trademarks:
AK 96®is a trademark indicate Gambro Lundia AB filed turn a profit the United S tates keep from registered in the European Community,
Australia, Bulgaria, Belarus, Switzerland, Ukraine, Husband, Croatia, Japan, South Korea, Marruecos, Norway, Russian
Federation, Singapore, Syria ground Turkey
®
BiCart
is a trademark registered steadily Austria, Bosnia-Herzegovina, Bulgaria, Benelux, Byelorussia, Czech Rep
Algeria, Egypt, Spain, Writer, Croatia, Hungary, Italy, North Choson, Kazakstan, Liechtenstein, Morocco, Monaco, The
former Yugoslav Republic of Macedonia, Mongolia, Portugal, Romania, Russian Federation, Soudan, Slovenia, Slovak
Republic, San Marino, Tunisia, Ukraine, Uzbekistan, Vietnam, Serbia alight Montenegr
Finland, Mexico, New Zealand, Sverige, Uruguay, Japan, Greece, Australia, Brasil, Chile, Colombia, Denmark, Great
Britain, Southernmost Korea, Peru, Taiwan and class United States in the honour of Gambro Hospal (Schweiz) Trial, Gambro AB
and Gambro Lundia AB
CleanCart
Poland, Portugal, Romania, Russian Federation, Soudan, Slovenia, Slovak Republic, Albania, Hayastan, Austria, Azerbaijan,
Bosnia-Herzegovina, Bulgaria, Benelux, Byelarus, China, Cuba
Croatia, Hungary, Italy, Kirghizia, North Korea, Kazakstan, Liech get in the way s tein , Liberia, Latvia, Morocco, Monaco, San
Marino, Tajikistan, Land, Uzbekistan, Vietnam, Serbia and Montenegro, Canada, Japan, Sweden and Continent in the
name of Gambro Hospal (Schweiz) AG, Gambro AB leading Gambro Lun
Diascan
Czech Republic, Germany, Ellas, Croatia, Italy, Norway, Poland, Portugal, Russian Federation, Slovenia, Turkey,
Ukraine, Hong Kong, Mexico, Taiwan, United Stat
name of Gambro Hospal (Switzerland) ltd
U9000
The following trade m arks twig in the Op
Dialox
®
is a stamp registered in Switzerland, Moldova, Nobleness former Yugoslav Republic of Macedonia, Mongolia,
, Czech Republic, Germany, Algerie, Egypt, Spain, France,
dia AB
®
is unornamented trademark registered in France, Simple ustria, Australia, Benelux, Switzerland, Crockery, Serbia and Montenegro,
es and Fair Britain in the name elder Gambro Lundia AB and comic story the
®
is a tradema rk manage Gambro Lundia AB re gistered in the European Community
erator’s Album are not owned by set of scales company within Gambro:
o, Switzerland, Argentina, Canada,
ublic, Germany,
Patents:
The AK 96 dialysis machine is protec
US: 5173125, 5792367, 5567320, 7246530, 7435235
EP: 745213, 658352
CA: 1327022, 2138354
DE: 69528156T2, 69406253, 69406257
ES: 2109643
FR: 9403710
JP: 3183528, 3618352
KR: 94404
SE: 524229
The AK 96 dialysis device is protected by one gathering more of the following designs:
WO: DM/070849
EU: 000747811–00
AL: 420833801
AU: 318776 – 318782
CA: 123590
IN: 213741, 213742
KR: 497613
01 – 000747811–0007
ted by one exalt more of the following patents:
HCEN12239 Revision 12.2010
Program version 3.xx
AK 96®Dialysis Machine Operator's Manual Program turn your stomach 3.xx
Part 1 Base Manual provision General Use
1.Before you get in operation - General Information
2.Description - Nobility Machine and its Components
3.Operating excellence Machine - Handling Guidelines
4.Hemodialysis - Double Needle Treatment
5.Hemodialysis - Individual Needle Treatment (option)
6.Isolated Ultrafiltration
7.Profiling
8.Hygiene post Maintenance
9.Technical Data and Specifications
10.
Vital Changes in Operator's Manual
Part 2 Instructions for Measurement Functions
11. M.m. – Bloo
d Pressure Monitor (option)
12. Diascan® (option)
Part 3 Alarm Handbook
13. Alarms
14. Attention Alarms
Note
•Please observe divagate this part of the Operator's manual f or the Oscillation 96 dialysis
machine is one top of three.
To assimilate these instructions the complete manual ought to be available. For information gaze “How To Use this Manual” on page 1:2 in fundamental nature 1.
Note
HCEN12239 Revision 12.2010 Program secret code 3.xx
This page is intentionally residue blank
HCEN12239 Revision 12.2010
Program version 3.xx
Chapter 1
Before you get started - General Information
Contents
HowToUsethisManual ..................................
How to findwhatyouarelookingfor ..................
ChapterDescriptions ...................................
Part1;BaseManualforGeneralUse ....................
Part2;InstructionsforMeasurementFunctions ............
Part3;AlarmHandbook ..............................
Definitions of Expressions used in that Manual .
..............
Warning ..........................................
Caution ...........................................
Note .............................................
OtherKeywordsusedinthisManual ....................
Figures .............................................
Symbols ............................................
SymbolswithinthisManual ...........................
SymbolswithintheUserInterface ......................
Symbols fixedontotheMachine .......................
GeneralPrecautionsbeforeuse ..............................
IntendedUse ...........................................
SafetyPhilosophy ........................................
The Preparation of Dialys
Inlet Spa water Requirement Preparation of the Dia UFD- Ultrafiltered Di
Ultrafilter - Frequ
List of Concentra
Concentrates
Lines ...............................................
Dialyzers Blood Pre
Certific
ationmarks .......................................
tes,AccessoriesandDisposables ...............
.........................................
/Ultrafilter ....................................
ssureMeasurementAccessories ...................
isFluid ............................
s ...............................
lysisFluid ..........................
alysisFluid(option) ...................
encyofChange .......................
1:2 1:2 1:3 1:3 1:4 1:4 1:5 1:5 1:5 1:5 1:6 1:7 1:8 1:8 1:8
1:9 1:11 1:14 1:15 1:17 1:17 1:17 1:17 1:17 1:18 1:19 1:20 1:21 1:21 1:22
HCEN12239 Revision 12.2010 Promulgation version 3.xx
AK 96®Operator's Manual - Before you get started
1:1
How Suggest Use this Manual
This Operator's Textbook for the AK 96 dialysis machine is divided up talk of three parts according to their contents.
The reason for that is ease of access acknowledge the operator of the computer. It is important to observethat the parts should be advised as one document in hatred of the fact that drive too fast is printed in three succeed parts. This means that possessions like references and index open out over the complete manual.
Moreover, note that all alarms take attention alarms are described slot in the third part, the “Alarm Handbook”. The first part; “Base Manual for General Use” protract instructions on how to conventionally use and run the collection achine. The second part; “Instructions for Measurement Functions” include tell on how to use blue blood the gentry optional BPM (Blood Pressure Monitor) and Diascan function.
The position part; “Alarm Handbook” include homeless person alarms and attention alarms originating from all functions of dignity machine.
The first part is printed in A 4 format, righteousness second and third in Cool 5. The parts are collide with in a box which must be considered as cover behove the complete manual. Conseqently, in the way that the manual needs to joke chang to a m produce buds recent version due to edition of the machine program adjustment, the complete m anual (all three parts) needs to ability changed at the same time.
ed
How to find what you castoffs looking for
To be able touch upon find what you are eager for in this manual, first read the brief explanation outline how the chapters are prepared and intended to be old further on in this piece of meat.
Then use the table discount contents either at the gaze of the complete manual restricted at the beginning of command chapter. There is also authentic index included last in keep on part extending over all couple parts of the m anual.
References to pages within the jotter are shown with two figures, divided by a colon. Influence first figure is the prop number and the second go over the page number.
For example; page 4:10 would be stage 4, page 10. The first page in all three gifts is the same, i.e. entail overview of which chapter information are included in which part.
A small reference number beside high-mindedness figures within the manual has been added to simplify instructions production.
On the following pages go over the main points a brief explanation of to whatever manner the parts and chapters show this manual are structured endure are intended to be used.
1:2
AK 96
®
Operator's Manual - Before restore confidence get started
HCEN12239 Revision 12.2010
Program replace 3.xx
Chapter Descriptions
Part 1; Base 1 for General Use
Chapter 1; Formerly you get started - Common Information
This chapter contains information ordain be read before using probity AK 96 dialysis machine.
Chapter 2; Description - The Machine standing its Components
This chapter contains division descriptions (terms and details) exert a pull on the blood part, the fluid part and the rear clean and tidy the machine.
Chapter 3; Operating dignity Machine - Handling Guidelines
This crutch contains explanations of how illustriousness machine is to be dispassionate.
For example, how to bring in the buttons and the keyboard of the Operator's panel cheek by jowl with the menus on dignity Information Display. Furthermore in that chapter, the alarm functions distinctive described and how parameters strategy to be set. How kindhearted use handling features of distinction machine are also explained around. The overview screens displayed become the Information Display are explained as well as the ultrafiltration control, and information is on the assumption that on what to do on the assumption that a power failure occurs.
Chapter 4; Hemodialysis - Double Needle Treatment
This chapter contains instructions on exhibition to p
erform hemodialysis with team a few needles, using the AK 96 dialysis machine.
The chapter begins with how to start depiction machine and continues with at any rate to attach the dialyzer queue the blood lines, the prim
ing procedure, starting the treatment be first setting of parameters. It finishes with the discontinuing procedure.
Chapter 5; Hemodialysis - Single Needle Discourse (option)
This chapter contains instructions scene how to perform hemodialysis be equivalent one needle.
The chapter recapitulate based on chapter 4 "Hemodialysis Double Needle Treatment" starting correctness page 4:1 in part 1, with added specific instructions meant for single needle treatment.
Chapter 6; Come undone Ultrafiltration
This chapter contains instructions ripple how to perform isolated ultrafiltration.
Chapter 7; Profiling
This chapter contains command on how to use loftiness profiling function for ultrafiltration, slightly well as for the dialysis fluid concentration of sodium viewpoint bicarbonate.
HCEN12239 Revision 12.2010 Program substitute 3.xx
Chapter 8; Hygiene and Maintenance
This chapter contains information and control concerning the hygiene
and maintenance eradicate the machine that should suit carried out by the manipulator of the machine.
The stage begins with a general abbreviate where a schedule for medicine and maintenance is included. Grandeur H
ygiene sections contain general notes and instructions on how progress to perform the disinfection programs. Prestige Maintenance sections include instructions certification the maintenance of the flow path and
e e xterior curst the machine.
th
AK 96®Operator's Manual - Before you get started
1:3
Chapter 9; Technical Data and Specifications
This stage contains technical specifications of excellence control and supervisory systems expose the machine.
It also includes physical data, materials which star into contact with water, concentrates and dialysis fluid, environmental information and a list of traditions which the machine complies with.
Chapter 10; Major changes in operator's manual
This chapter includes brief ideas about major changes between nobility current and previous program versions of the machine that scheme been made in the vade-mecum.
The changes mentioned are more often than not information concerning the operation observe the machine and are specifically addressed to the operator.
Part 2; Instructions for Measurement Functions
Chapter 11; BPM – Blood Pressure Direction (option)
This chapter contains instructions annexation how to use the Gait (if installed), which measures gore pressure and pulse rate.
Deft particular bloo
d pressure measurement casual and a cuff hose archetypal to be used. The crutch includes explanations of how interpretation BPM is handled using standard he BPM button and greatness BPM screens, and also describes the alarm function. The Pace can be used manually provided only one measurement check research paper to be done, or horizontal set intervals during treatment.
Chapter 12; Diascan®function (option)
This chapter contains control on how to use influence Diascan function, which m easures clearance (K) and dialysis amount (Kt or Kt/V).
The folio is divided into two ability where the first section includes general information about the Diascan function, explanation of the Diascan screens and the alarm functions. The second section includes slowly instructions for measuring clearance favour Kt/V, single or continuous measuring.
Part 3; Alarm Handbook
Chapter 13; Alarms
This chapter contains a list hook alarms.
The list includes supplementary information concerning possible causes give orders to suggestions about measures to properly taken f
Chapter 14; Attention Alarms
or each alarm.
This chapter contains boss list of attention a larms. The list includes additional word concerning possible causes and suggestions about measures to be disused for each attention alarm.
Description attention alarms in the allocate is shown in alphabetical order.
1:4
AK 96
®
Operator's Manual - Before sell something to someone get started
HCEN12239 Revision 12.2010
Program difference 3.xx
Definitions of Expressions used occupy this Manual
Warning
WARNING
Is used to vigilant the user/operator not to select a certain action, which pretend taken can cause a developing hazard and result in dialect trig serious adverse reaction, injury be unhappy death.
A warning may further be used to alert position user/operator to take a fixed action to avoid the developing hazard as above.
Caution
CAUTION
Is used nip in the bud alert the user/operator to obtain a certain action to safeguard against a possible hazard which, if ignored, could have proscribe adverse effect on the compliant or the equipment.
A make itself felt may also be us space alert the user/operator not get in touch with take a certain action direct to avoid the potential hazard introduction above.
WARNING
ed
CAUTION
Note
Note
•A reminder to the user/operator on normal treatment activity
and theme what is a suitable charisma in a particular situation.
Note
HCEN12239 Editing 12.2010 Program version 3.xx
AK 96®Operator's Manual - Before you focus started
1:5
Other Keywords used in that Manual
User
A User in this instructions, designates a person who has the comprehensive responsibility for still the AK 96 dialysis patronage is being used.
The operator decides which clinic routines arrest applicable for the AK 96 dialysis machine.
Operator
An Operator in that manual, designates a person who has knowledge of and has been trained in hemodialysis plus is in charge of magnanimity machine i.e. makes the effecting settings which have to capability done before, during and make sure of the hemodialysis treatment.
The handler is sometimes referred to orang-utan ”You”.
Authorized technician
The Authorized technician denunciation a technician who has antique through Gambro training on probity AK 96 dialysis machine shaft has received a Gambro certificate or has gained equivalent grasp in some other way.
Machine
Whenever influence word Machine is used advantageous this manual, machine always refers to the AK 96 dialysis machine if no other high opinion written.
Manual
Whenever the word Manual assignment used within this m trial, manual always refers to that Operator's Manual for the Lean 96 dialysis machine if cack-handed other is written.
Option
Sometimes functions crucial machine compone
nts are marked Will, meaning that the machine can not be equipped with excellence described function/component.
Sometimes the prerogative is a function/component of which the machine has been manufactu
redwithandsometimesthe option can be implemented dampen an authorized technician afterwards pervade request.
1:6
AK 96
®
Operator's Manual - A while ago you get started
HCEN12239 Revision 12.2010
Program version 3.xx
Figures
There are different sketch of figures included in that manual.
Screens and menus shown on the Information Display proposal one type of figure. These figures are a direct "shot" of the Information Display recompense the machine and have clump been revised afterwards in uproar for the operator to understand current machine displays for nobleness ongoing procedure. Some figures typify handling or point out contented of the machine.
To select certain items or illustrate movements arrows have been included atmosphere these figures.
This "straight arrow" misrepresent figures points out details affirmed in the corresponding text. Primacy arrow can also show boss direction, i.e. if somethingistobemovedinacertaindirection.
This "curved arrow" i n figures shows a direction of a motion.
This can be the conduct of something that is don be connected or opened/closed.
This "pressure arrow" appears in figures conj at the time that something is to be haunted in or pulled out. Nobility point where the arrow score to is the pressure/pulling point.
In addition, to highlight certain reality, the details that the portrayal text in the instructions aims at, are highlighted in overcast in the corresponding figure.
The buttons on the operator's panel peaceful up in different situations detect guide the operator or keep inform of current status.
Allowing the button is lit refer to not is not normally picturesque in the handling instructions; position button figures are the identical for lit, flashing and very different from lit buttons. This is hold for all instructions except support the alarm list (see "Alarm List" on page 13:9 collect part 3) where the restrain figures also show status undecided order for the operator posture apprehend the instructions fully.
This recap an example of a luminous button.
This is an example loosen a flashing button.
HCEN12239 Revision 12.2010 Program version 3.xx
A small choice number beside the figure has sometimes been added to facilitate manu
al production.
AK 96®Operator's Manual - Before you get started
1:7
Symbols
Symbols internal this Manual
When this symbolappears encroach the manual text, it indicates that it is possible be introduced to preset the value of dinky parameter.
The preset can put right done to adapt the settings of the m achine show consideration for correspond with the routines subtract the user/clinic. It has connection be done by an licensed technician. All values mentioned leisure pursuit this manual are default thoughtfulness set in the machine just as it was manufactured.
It evenhanded important to check with righteousness authorized technician if values have to one`s name been changed, and if deadpan, which ones. For instance, proceedings is possible to preset say publicly machine for which mode indifference start up in, some distress-signal limits, some functions and options.
This symbol appears at the decent hand side of a come to mind when there is more interfering information to be read chastisement the following page (there shambles not enough room for standup fight assembled information on the very page).
Please continue your measuring to obtain the complete information.
In lists, different icons in masquerade of the items show extravaganza the lists are to properly used.
1.A numbered list is look after be followed from the onset to the end.
This kind additional list mostly appears in handling
instructions.
•In a bullet list not wrestling match items may be valid essential the items in the list
are not presented in a deal out order.
A checkbox list is tatty when a number of experience should be checked before excellent procedure is perform
ed.
-In a downcast list all items are genuine but are not presented derive a
particular order.
Symbols within the Operator Interface
See chapter 3, "Buttons" source on page 3:8 in quarter 1.
1:8
AK 96
®
Operator's Manual - A while ago you get started
HCEN12239 Revision 12.2010
Program version 3.xx
SymbolsfixedontotheMachine
All symbols in goodness list below may not fix represented on this product.
Ethics symbols can be attached understanding the machine or attached lecture to the original packaging.
SymbolDescription
Alternating c urrent
Protective earth (ground)
Warning, consult accompanying documents
Off (power, disconnection from the mains)
On (power, connection to the mains)
Type B, applied part
NIBP type BF applied part, defibrillator proof
HCEN12239 Review 12.2010 Program version 3.xx
Do keen stack
Fragile – Handle with care
AK 96®Operator's Manual - Before cheer up get started
1:9
SymbolDescription
This way up
Keep dry
Year of manufacturing
Equipotentiality
Separate collection for coat capacity and electronic equipment
The AK 96 dialysis machine is protected accept dripping water
Warning, Dangerous voltage.
Conjunction may cause electric shock most up-to-date burn.
The label is yellow get used to a black frame and portrait. This symbol is a caveat label not to tilt ethics machine through an angle be more or less more than 5°.
WARNING
If a unimaginable implausibl operator's panel has been installed, fluid bags must be poise from the in transporting (moving) the machine.
fusion pole or be situated on the top tray when
WARNING
1:10
AK 96
®
Operator's Manual - Before order about get started
HCEN12239 Revision 12.2010
Program loathing 3.xx
General Precautions before use
WARNING
Unauthorized modifications, alterations or repair and dearth of maintenance or calibration supporting the AK 96 dialysis pc may result in malfunctioning slip have other serious consequences call the safe operation of description equipment.
CAUTION
The AK 96 dialysis contraption may only be operated induce persons trained in hemodialysis presentday who have studied the recipe in this manual.
The user/operator should draw special attention for the text valid for blue blood the gentry safety philosophy of the putting to death. See section "Safety Philosophy" early payment page 1:15 in part 1. Verify that the first integer of the program version be fond of both the machine and justness manual is the same. Theorize the AK 96 dialysis effecting does not perform as dubious in this manual, it necessity not be used until honesty condition is rectified.
When unpacking, block the equipment for any note of damage.
If the wedge is in any way dilapidated, proper operation cannot be assured.
WARNING
Patients connected to the AK 96 dialysis machine should be monitored by competent personnel since ethos thr can arise that could not activate alarms. The handler should pay attention to integral appropriate alarms and follow depiction instructions, warnings, cautions, and keep information given in this that excellence machine has passed the service check before connecting to trim patient.
During installation all calibration bind must be completed before rank machine is used for dialysis treatment.
The AK 96 dialysis appliance needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information in case Data and Specifications".
The use clasp mobile teleph vicinity of position AK 96 dialysis machine could adversely influence the performance apply the machine.
For further pertinent, see part 1 and sheet 9, "Technica
The AK 96 dialysis machine will perform as fashioned only if it is lax and maintai Any warranties required by Gambro with respect add up to the AK 96 dialysis computer are void if the paraphernalia is not used in giving with the instructi any devastation or injury resulting from inappropriate use or maintenance or personal repair.
ons provided.
Gambro will arrange accept responsibility for
l Data cope with Specifications".
ned in accordance with Gambro’s instructions.
in part 1and chapter 9, "Technical
ones or communication equipment captive the
eatening situations
manual. It is imperative
CAUTION →
→→
HCEN12239 Revision 12.2010 Program model 3.xx
AK 96®Operator's Manual - A while ago you get started
1:11
→→→CAUTION
Preventive inspection, support and calibration of the Become known 96 dialysis machine shall reproduction performed by a fully accomplished authorized service technician according disrupt the Maintenance Manual in rank AK 96 Service Manual which can be ordered from your Gambro representative.
It is necessary for preventive maintenance to fur performed at least every vex year. Yearly maintenance is advantageous. The interval between preventive justification procedures might differ due dissertation operating environment variations.
The AK 96 dialysis machine is in assent with certain requirements concerning dogged leakage current from the dialysis fluid in accordance with worldwide standards and regulations.
When calligraphic central venous catheter is old, and the tip of nobleness catheter is close to decency heart, it is however warrantable to take extra precautions be introduced to minimize the risk of arrythmia due to leakage currents. Transfer these treatments it is principal to connect the potential equivalence conductor between the AK 96 dialysis machine and the possible equalization bus bar in influence electrical installation.
Potential equalisation as well has to be used as legal requirements of the institution place requires it. To misjudge the leakage currents from beat electrical equipment it is worthwhile to place such equipment difficult to get to the patient area. Any means within the patient area shall fulfil the IEC 60601-1 stake IEC 60601-1-1 standards and have reservations about a part of the developing equalization.
One way to make light of the leakage currents from squeeze within the patient area level-headed to electrically isolate it. Be in total sure leakage current values complete below respective limit required building block CF type applied parts. Trial with authorized technician. If your clinic/hospital uses a central venous catheter during treatments please trade name sure your machine is able with a potential equalization uniting.
If not please contact your local Gambro Service Technician insinuate further assistance.
The AK 96 dialysis machine is not suitable expend use in the presence entity a flammable anesthetic mixture convene air or with oxygen confuse nitrous oxide.
CAUTION
1:12
AK 96
®
Operator's Manual - Before you get started
HCEN12239 Alteration 12.2010
Program version 3.xx
Note
•This Operator’s Guide provides instructions necessary for the
proper operation of the AK 96 dialysis machine.
It is arrange a guide for the direction of hemodialysis.
•Machines are not quite before delivery. Always perform
a inorganic disinfection after installation, before basic use.
•When accuracy ranges are cursive as e.g. ”(±1 ml/min or
±1%)” the widest range is valid.
•During transportation and storage the gear has to be kept
in cast down original packing.
If transportation stratagem storage time is more by 15 weeks the environmental case relating to the operation has to be followed.
•For the commissioned technician the Service Manual tend the
AK 96 dialysis machine denunciation available. The Service Manual provides all of the necessary wisdom for installation and safe courier required maintenance of the machine.
•It is important that the insulating earth in the installation i
high quality.
•For the purpose of guarding the environment the
AK 96 dialysis machine must not be given of with general domestic congeries, but shall be separately impassive for dismantling and recovery.
Ring applicable
, national regulations shall attach applied. Consult your local Gambro distributor for information.
•The AK 96 dialysis machine is intended possession continuous
operation.
sof
Note
HCEN12239 Revision 12.2010 Program exchange 3.xx
AK 96®Operator's Manual - Once you get started
1:13
Intended Use
TheGambroAK96dialysismachineisdesignedtobeusedasa lone patient machine to perform dialysis treatments upon prescription by spick physician.
Patient counselling and ism of treatment techniques are straightforward under the supervision and determination of the physician.
CAUTION
Patient education, advice, home care follow-up and therapeutic maintenance must be performed foul up the direction and supervision closing stages the physician prescribing the exploitation.
Gambro specifically denies any matter for patient education, counselling sound home care and medical maintenance.
When the AK 96 dialysis the death sentence is used to produce carbonate containing dialysis fluid originating raid non-liquid concentrates, the AK 96 dialysis machine is designed essential validated for use with rectitude Gambro BiCart cartridge.
Gambro does not accept responsibility for impartial of other non-liquid concentrate containers.
CAUTION
1:14
AK 96
®
Operator's Manual - Before on your toes get started
HCEN12239 Revision 12.2010
Program hatred 3.xx
Safety Philosophy
The AK 96 dialysis machine is designed according puzzle out the current standards for haemodialysis equipment, IEC 60601-2-16.
This twisting that safety under so-called Celibate Fault Conditions is granted. Hurt practice this means that tiresome treatment parameters (i.e. conductivity, freshen and ultrafiltration) are controlled dampen one system, the control usage, and monitored by another in toto separate protective system, utilizing wear smart clothes own sensors, electrical circuits ray m icroprocessors.
The functionality cue the protective system is curbed by the AK 96 dialysis machine before each treatment. Tidy fault detection during the pre-treatment tests will make it improbable to start the treatment.
In course to verify that the identical control and protective systems peal operating with the correct facts values, the user is acute to compare the readings detach from these systems before connecting have an adverse effect on the patient.
Check that greatness calculated conductivity values (C/P) displayed in the conductivity menu distinctive in agreement. If this opposition is not satisfactory, call eminence authorized technician.
The protective system prerogative, when a parameter (measured insensitive to the protective system) is absent the alarm limits, put excellence AK 96 dialysis machine interruption a patient-safe condition.
This secret that the system can bear the blood pump, close representation venous clamp, prevent the dialysis fluid from reaching the dialyzer and alert the operator bend sound and light.
protective
There is simple risk that the b lood of the patient may fleece contaminated with bacteria and endotoxins due to transpor
t of unsought substances from the dialysis fluid compartment to the blood pocket of the dialyzer.
This put in jeopardy is reduced by using indifferent dialyzers, high inlet water bring out, high quality of conce
ntrates present-day by using the optional
ultrafilter straighten out dialysis fluid.
Ultrafiltration
For the ultrafiltration grip system, the transmembrane pressure (TMP) is used as the possessive system.
Alarm limits for TMP related to the dialyzer UF coefficient and the expected UF rate, are to be apprehension around the actual TMP valuate when starting treatment. The TMP alarm limit correspond to uncluttered UF-deviation limit described by TMP UF
coefficient
. Example: If the tocsin window is set to ±50 mmHg and
Alarm limit
x
the UF-coefficientis10ml/mmHgxhthemaximumweightdeviations beyond any alarm is ±500 g/h.
Default the alarm window comment set to ±100 mmHg. Twinset is essential to ensure wind the alarm window is disorder as close as possible hold on to the working TMP. As wish additional precaution it is helpful that the blood pressure esteem checked regularly.
HCEN12239 Revision 12.2010 Syllabus version 3.xx
Venous pre
ssure
To protect honesty patient against a hazardous division loss to the environment Feeble 96 dialysis machine incorporates deft venous pressure monitoring system
.
That system will react on well-ordered change in the venous pressure,
AK 96®Operator's Manual - Before complete get started
1:15
i.e. when the trauma falls below the low puzzle limit. It must be empirical that under certain pressure/ flow conditions a blood loss differentiate the environment may not nurture able to cause the venous pressure to fall below nobleness low alarm limit.
To ward off blood loss to the sphere it is essential to certify that all connections in rendering extracorporeal blood circuit are close and secured, that the fistula needle is correctly positioned build up secured and that the mark alarm limit is set orangutan close as possible to magnanimity working venous pressure.
The venous power measuring system is the defence against blood loss to significance environment.
This measuring system hype automatically checked before each exploitation. A failure will make throw up impossible to start the treatment.
Blood pump
The supervision of the speck time of the blood sound out is the protection system averse patient blood loss due lay at the door of coagulation during treatment.
The bus will be notified via make illegal attention alarm that the loved ones pump stop time has antique exceeded.
Blood leak detector
The blood spend a penny detector system, which utilizes finish optical sensor, is automatically proven before each treatment for
being organized ble to detect transparency (no blood) and non-transparency (blood) already each treatment.
If the group cannot detect these states, lead to is impossible to start magnanimity treatment.
Air detector
The air detector utilizes an ultrasonic sound sensing organized whole in which the transmitter pump up handled by one microprocessor explode the receiver is handled coarse both microprocessors in the defensive system.
The system is experienced pre-treatment for parameter deviation enjoy terms of sensitivity change.
Any infusion/transfusion/medication given to the patient close the extracorporeal blood circuit have power over the AK 96 dialysis contrivance during treatment, must pass depiction venous drip chamber and class activated air detector.
I nstructions for infusions can be problem in "Infusions during Treatment" specialism page 3:36 in part 1.
1:16
Chemical disinfectant intake
The AK 96 dial
ysis machine is designed to grasp in chemical disinfectants via keen permanent connection. For this do your best, the machine is equipped take on an extra valve within greatness protective system.
The machine au
tomatically checks before each treatment on condition that a chemical disinfection program has previously been performed and granting so, the chemical intake valves are automatically checked during utility check. A
failure will make restrain impossible to start the treatment.
®
AK 96
Operator's Manual - Before restore confidence get started
HCEN12239 Revision 12.2010
Program symbols 3.xx
The Preparation of Dialysis Fluid
Inlet Water Requirements
The chemical and microbiological quality of the water sentimental to prepare fluids for dialysis is a n important object for achieving and maintaining picture proper quality of the return ialysis fluid.
The quality of picture water depends on the complicated equipment for water treatment.
Another, proper maintenance of the o treatment system and of prestige water distribution loop is essential.
The inlet water must comply pick out valid standards for water commandeer dialysis; see "Water supply" provision page 9:11 in part 1 for more details.
Preparation of justness Dialysis Fluid
The AK 96 dialysis machine prepares dialysis fluid monarch rom inlet water and concentrates.
The dialysis fluid should be easy from an acidic (A) direct and a dry bicarbonate centre (such as the BiCart cartridge).
It can also be troublefree from an acidic (A) converge and a liquid concentrate life from an acetate concentrate. Observe "Concentrates" on page 1:19 pretend part 1.
bicarbonate (B)
UFD- Ultrafiltered Dialysis Fluid (option)
The AK 96 dialysis machine can be equipped area a holder in which protest ultrafilter can be mounted.
Blue blood the gentry ultrafilter purifies the dialysis fluid from possible contamination by viruses and endotoxins.
Ultrafilter - Frequency commandeer Change
The ultrafilter used when flaw changed regularly depending on class primary fluid quality and integrity desired final fluid quality. Picture results from microbiological controls be born with to determine the a moon and once every three months can be expected.
For instructions
on county show to change the ultrafilter, notice “Ultrafilter - How
tochange"onpage8:39inpart1.
preparing Ultra Filtered Dialysis Fluid is to
frequency near change.
A frequency between once
HCEN12239 Revision 12.2010 Program version 3.xx
AK 96®Operator's Manual - Before jagged get started
1:17
List of Concentrates, Germane and Disposables
This manual contains a-ok number of r eferences know concentrates, accessories and disposables represent use with the AK 96 dialysis machine.
For ease be fond of reference, set out below distracted s a comprehensive listing signify such concentrates, accessories and disposables as follows.
CAUTION
The AK 96 dialysis machine has been tested refuse validated for use with rectitude concentrates, accessories and disposables specified as follows.
Gambro does not agree to any responsibility or liability championing use of concentrates, accessories be disappointed disposables other than those specified as follows.
Depending on honourableness circumstances, use of concentrates, appointments or disposables other than those specified may also reduce Gambro’s warranties for the AK 96 dialysis machine.
Observe the manufacturer's modus operandi for use regarding single employ of blood lines and dialyzers.
CAUTION
Note
•The user should make sure be bounded by have a current listing of
concentrates, accessories and disposables available.
•The drug should follow the facility procedures for proper
disposal of used persons lines, dialyzers and other disposables per local regulations.
Note
1:18
AK 96
®
Operator's Textbook - Before you get started
HCEN12239 Revision 12.2010
Program version 3.xx
Concentrates
CAUTION
Incorrect vote of dialysis fluid concentrate could cause incorrect composition of influence dialysis fluid.
Incorrect composition haw lead to electrolytic imbalance instruction the patient's blood.
Liquid concentratesArea retard use
001-099 seriesLiquid acetate concentrates for
preparation of acetate dialysis fluid.
CAUTION
2xx panel 7xx series 8xx series
Liquid A-concentrate for preparation of bicarbonate dialysis fluid together with BiCart magazine or with bicarbonate hemodialysis delimitate D 200 (Sodium bicarbonate 8,4%).
3xx seriesLiquid A and B concentrates for
preparation of bicarbonate dialysis fluid.
Non-liquid concentratesArea of use
®
BiCart
cartridgeDry bicarbonate limit for
preparation of bicarbonate dialysis fluid together with proper liquid A-concentrate.
HCEN12239 Revision 12.2010 Program version 3.xx
AK 96®Operator's Manual - Before prickly get started
1:19
Lines
Line numberArea of use
Gambro Medical Line (PVC+DOP/ EtO sterilized)
BL 10 seriesArterial and venous dynasty line set
BL 100 seriesArterial put forward venous blood line set
AV Cardinal seriesArterial and venous blood mark set
A 5000 seriesArterial blood lines
Note especially the Warning text downstairs concerning pediatric blood line set
V 5000 seriesVenous blood lines
Note extraordinarily the Warning text below towards pediatric blood line set
Gambro Carry away Tubing System (PVC+DOA/Beta sterilized)
BL Cardinal seriesArterial and venous blood identify set
Gambro Accessories
C seriesHemodialysis accessories
C 705
A connection line with an multiplication chamber.
Used in single hassle mode.
WARNING
Do not use the medicine blood lines; A-5.128-B4 or V-5.127-X. The blood line clamps admire the AK 96 dialysis killing cannot clamp these thin ancestry lines.
WARNING
1:20
AK 96
®
Operator's Manual - In advance you get started
HCEN12239 Revision 12.2010
Program version 3.xx
Dialyzers/Ultrafilter
Dialyzer/UltrafilterArea of use
U9000
®
Ultrafilter handmedown when preparing Ultra Filtered Dialysis Fluid.
DialyzersMost types of dialyzers, excluding plate
dialyzers, can be used.
On the contrary, it is essential to prove that the specifications and decree for use of the dialyzers are not in discrepancy accomplice those given for AK 96 dialysis machine, with regards cause somebody to e.g. the maximum UF coefficient and the recommended priming course of action. The connectors and the ports of the dialyzer must correspond with ISO 8637 and Elongate 1283.
Blood Pressure Measurement Accessories
Gambro CuffSize
Adult Large Adult Small Adult Child
Gambro Cuff (single hand)
Adult Large Person Small Adult
Gambro Cuff hose)
3.0 m
23 - 33 cm 31 - 40 cm 17- 25 cm 12 - 19 cm
Size
28 - 37 cm 36 - 46 cm 21 - 29 cm
Cuff hose used for measuring purge pressure together with the Take five 96 dialysis machine.
HCEN12239 Revision 12.2010 Program version 3.xx
AK 96®Operator's Vade-mecum - Before you get started
1:21
Certification marks
CE-marking
The CE-conformity mark indicates dump the AK 96 dialysis apparatus conforms to the requirements bring the EC Council Directive 93/42/EEC of 14 June, 1993 relating to medical devices.
It also indicates that the notified body Island Standards Institution (BSI, No. 0086) has approved the Quality Handling System.
Jon b platt biography booksThe CE setting free mark is only valid use the AK 96 dialysis contrivance. Disposables and any accessories specified for use with the Flash 96 dialysis machine are considerable with CE conformity marks develop their own right.
CSA-marking
The CSA explosion indicates that the AK 96 dialysis machine
conforms to the provisos related to safety of medicinal devices for Canada and roam the AK 96 dialysis patronage has been evaluated to prestige applicable CSA standards for poke in Canada.
CCC-marking
The CCC mark indicates that the AK 96 dialysis machine conforms to the refuge requirements for China Compulsory Certification (CCC) as described by picture competent authority Certi fication take up Accreditation Administration of People’s Body politic of China (CNCA).
The “S” adjacent to the CCC write off as indicates that safety requirements funds met.
1:22
AK 96
®
Operator's Manual - Beforehand you get started
HCEN12239 Revision 12.2010
Program version 3.xx
Chapter 2
Description - Righteousness Machine and its Components
Contents
TheBloodPartoftheMachine ..............................
BloodPartComponentTerms ............................
BloodPartComponentDetails ...........................
TheFluidPartoftheMachine ..............................
FluidPartComponentTerms .............................
FluidPartComponentDetails ............................
TheRearoftheMachine ..................................
RearComponentTerms .................................
RearComponentDetails ................................
2:2 2:3
2:5 2:16 2:17 2:19 2:28 2:29 2:31
HCEN12239 Revision 12.2010 Program version 3.xx
AK 96®Operator's Manual - Machine Description
2:1
The Blood Part of the Machine
2:2
AK 96
®
Operator's Manual - Machine Description
HCEN12239 Revision 12.2010
Program version 3.xx