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AK 96
Gambro AK 96 User Manual
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Measures
:
Con
fi
rm
by
pressing
the
Select
key
and
the
machine
will
automatically
reschedule
measuring
as
soon
as
possible.
Mute
time:
No
buzzer
HCEN12
239
Rev
ision
12
.2010
Program
version
3.xx
AK
96
®
Operator's
Manual
-
Attention
Alarms
14:45
Attention
alarms
in
alphabetical
order
415
417
Table of Contents
Default Chapter
1
Important Information
1
Machine in this Manual
1
Previous Version of the Machine
1
Table of Contents
7
Before You Get Started - General Information
7
How to Use this Manual
8
How to Find What You Are Looking for . . . . . . . . . . . . . . . . . . Chapter Descriptions
8
Chapter Descriptions
9
Definitions of Expressions Used in this Manual
11
Warning
11
Caution
11
User
12
Operator
12
Authorized Technician
12
Machine
12
Other Keywords Used in this Manual
12
Figures
13
Symbols Within this Manual
14
Symbols Within the User Interface
14
Symbols Fixed on to the Machine
15
General Precautions before Use
17
Intended Use
20
Safety Philosophy
21
Ultrafiltration
21
Venous Pressure
21
Air Detector
22
Blood Leak Detector
22
Blood Pump
22
Chemical Disinfectant Intake
22
The Preparation of Dialysis Fluid
23
Inlet Water Requirements
23
Preparation of the Dialysis Fluid
23
UFD- Ultrafiltered Dialysis Fluid (Option)
23
List of Concentrates, Accessories and Disposables
24
Concentrates
25
Liquid Concentrates
25
Gambro Blood Tubing System (Pvc+Doa/Beta Sterilized)
26
Gambro Medical Line (PVC+DOP/ Eto Sterilized)
26
Lines
26
Blood Pressure Measurement Accessories
27
Dialyzers/Ultrafilter
27
Chapter 2 Description - the Machine and Its Components Contents
30
The Blood Part of the Machine
30
Blood Part Component Terms
31
Blood Part Component Details
32
Operator's Panel
32
Remote Operator's Panel
32
Top Tray
32
Arterial Pressure Transducer Connector
34
Venous Pressure Transducer Connector
34
Heparin Pump
37
Priming Detector
37
Arterial Blood Line Clamp
38
Potential Equalization Connection
38
Venous Blood Line Clamp
38
Arm for Dialyzer Holder
39
Expansion Chamber Holder
39
Blood Line Guides
40
BPM Connector
40
Level Adjustment Knob
40
BPM Cuff Holder
41
Infusion Pole
41
The Fluid Part of the Machine
43
Fluid Part Component Terms
44
Fluid Part Component Details
45
Safety Couplings for the Dialysis Fluid Tubes
45
Machine Inlet Dialysis Fluid Tube
46
Machine Outlet Dialysis Fluid Tube
46
Disinfection Port for Yellow Disinfectant Connector
47
Parking Port Marked P, for Yellow Disinfectant Connector
47
Yellow Disinfectant Connector
48
Base Plate
49
Blue Concentrate Connector with White Tube Marking
49
Red Concentrate Connector
49
Pick-Up Tube
50
Pick-Up Tube Holder
50
Stand-By Port for Red Concentrate Connector
50
Bicart Cartridge Holder
51
Stand-By Port for Blue Concentrate Connector
51
Dialysis Fluid Filter
52
The Rear of the Machine
54
Rear Component Terms
55
Rear Component Details
56
Transportation Handle
56
Air Filters
56
Halt Button
56
Battery Connect Indicator
57
Battery Charge Indicator
57
Outlet Tube
57
Inlet Water Tube
58
Disinfectant Inlet Tube
58
External Communication Port
58
Attachment for Service Table
59
Mains Connection
59
Fuses
59
Main Switch
60
Wheels
60
Operating the Machine - Handling Guidelines
62
Chapter 3 Operating the Machine - Handling Guidelines Contents
64
The Basics
64
The Handling Philosophy
65
The Flow Diagram
65
The Buttons
65
The Operators Panel
67
Time Display
67
Flow Diagram
67
The Blood Path
67
The Bypass Path
68
The Dialyzer Path
68
The Ultrafiltration Path
68
Page References for the Buttons in this Section
69
On/Off Button
71
Priming Button
71
Discontinuing Button
72
Rinse/Disinfection Button
72
Venous Pressure Button
72
Arterial Pressure Button
73
Time Button
73
Blood Flow
74
Blood Path Button
74
Heparin
75
Single Needle
75
BPM Button
76
Fluid Bypass Button
76
Fluid Path Button
76
UF Start/Stop Button
76
Temperature
77
Conductivity
78
Dialysis Fluid Flow Rate
78
Diascan
78
Transmembrane Pressure
79
Air Detector Button
80
Alarm Button
80
Attention Button
80
Mute Button
80
Blood Pump Button
81
Blood Pump Up/Down Keys
81
Keypad
81
Select Key
81
Back Key
82
Cursor Keys
82
Display Up/Down Keys
82
Left Cursor Key
82
Information Display
83
Viewing Angle Adjustment
83
Cursor Brace
84
Cursors
84
Lower Cursor
84
Overview Displays
84
Upper Cursor
84
The Ultrafiltration Control
86
Battery Back-Up Operation
88
Override Battery Back-Up Operation
88
Power Failure
88
Machine Shut down
89
Return the Blood During Machine Shut down
89
Recovery from Machine Shut down
90
Concentrate Stand-By Mode
91
Handling Features
91
Procedure for Manual Activation
92
Resume Fluid Preparation
92
Change of Bicart Cartridge During Treatment
93
Miscellaneous
93
Change of Blood Pump Segments
94
Change of Dialyzer and Blood Lines During Treatment
95
Resume Treatment
96
Infusions During Treatment
97
Post-Blood Pump Infusions
97
Pre-Blood Pump Infusions
97
Hemodialysis - Double Needle Treatment
98
Chapter 4 Hemodialysis - Double Needle Treatment Contents
99
Start the Machine
99
Check before Switching the Machine on
99
Switch the Machine on
99
Function Check
100
Set-Up the Machine
104
Connect/Confirm Concentrates
104
Concentrate Combinations
105
Acidic Concentrate and Bicart Cartridge
106
Attach Acidic Concentrate
106
Attach Bicart Cartridge
106
Acidic Concentrate and Liquid Bicarbonate Concentrate
108
Attach Liquid Bicarbonate Concentrate
108
Confirm Concentrates
108
Acetate Concentrate
109
Attach Acetate Concentrate
109
Attach Disposables
110
Dialyzer - Attach
112
Arterial Blood Line - Attach
113
Details
115
If Automatically Threaded
115
If Manually Threaded
116
Blood Line Guide
118
Dialyzer Connection
118
Arterial Line Clamp
119
Arterial Patient Connector
119
Arterial Pressure Connector
120
Check All Necessary Clamps
120
Preparations if the Heparin Pump Is to be Used
121
Venous Blood Line - Attach
124
Details
126
Venous Line Clamp
128
Venous Patient Connector
129
Venous Pressure Connector
129
Dialysis Fluid Tubes - Attach
130
Attaching Procedure
131
Assisted Priming
133
Manual Priming
133
Priming
133
Priming Part
133
Extra Priming Part
134
Recirculation Priming Part
134
Check before Priming
135
Manual Priming and Rinsing Procedure
135
Priming Procedure
135
If the Attention Alarm
137
When the Priming Volume
137
Extra Priming Procedure
139
Recirculation Priming Procedure
139
Assisted Priming and Rinsing Procedure
141
Check before Priming
141
Extra Priming Procedure
145
Recirculation Priming Procedure
145
Always Check/Adjust
147
Set Treatment Parameters
147
Connect the Patient
148
Start the Treatment
151
Alarm Limit Centralizing Function
152
Pressure Alarm Limits Setting
152
Tmp
153
Confirm Treatment End
154
Discontinuing
154
Return the Blood
155
Confirm Patient Disconnection
157
Machine Aftercare
158
Hemodialysis - Single Needle Treatment (Option)
162
Glossary of Single Needle Parameters and Key Terms
163
Preparations
164
Isolated Ultrafiltration
174
Chapter 6 Isolated Ultrafiltration Contents
175
Isolated UF - General
175
Isolated UF - Performing
176
Before Treatment
176
During Treatment
177
After Treatment
178
Profiling
180
Chapter 7
181
Profiling of Na and HCO Dialysis Fluid Concentration
181
General
181
Decreasing Graph in Steps for UF Rate Profiling
182
Decreasing Linear Graph for UF Rate Profiling
182
Profiling of Ultrafiltration Rate
182
Graph in Intervals for UF Rate Profiling
183
Change of UF Rate Linear Graph When Time Has Been Changed
184
Change of UF Rate Linear Graph When UF Volume Has Been Changed
184
Profiling Models
185
Profiling Setting/Activation
185
Profiling Without Preset Model
186
Setting and Activating the Model
186
Ultrafiltration
186
Bicarbonate
187
If Linear Graph
187
If Step or Interval Graph
187
Sodium
187
Profiling with Preset Model
189
Selecting and Activating the Model
189
Hygiene and Maintenance
192
Chapter 8 Hygiene and Maintenance Contents
193
Hygiene and Maintenance - General
193
Glossary of Disinfection Terms
194
Disinfection History
195
Schedule for Hygiene and Maintenance
197
When the Machine Is Planned Not to be in Use
198
Disinfection, Decalcification and Cleaning Agents - Characteristics 8:8
199
Hygiene - Heat Disinfection
200
Heat Disinfection - General
200
Heat Disinfection Program - Performing
202
Check before Starting the Procedure
202
Heat Disinfection Program with Cleancart® Cartridge - Performing 8:13
204
Heat Disinfection Program with Liquid Citric Acid - Performing
207
Integrated Heat Disinfection Program with WRO 300 H
210
Performing
210
Automatic Start of the Low Flow Heat Phase
211
Manual Start of the Low Flow Heat Phase
212
Check Whenever Activated
214
Heat Disinfection Program - Automatic Start
214
Programming and Activation Procedure
214
In Combination with Cleancart Cartridge
215
Heat Disinfection Program - Automatic Switch off
216
Integrated Heat Disinfection
216
Chemical Disinfection - General
217
Hygiene - Chemical Disinfection
217
Chemical Disinfection Program - Performing
218
Filling the Machine with Chemical Disinfectant
220
Residual Test after Chemical Disinfection
222
Central Chemical Disinfection - Performing
223
Hygiene - Rinse/Drain
225
Rinse/Drain - General
225
Rinse/Drain Program - Performing
225
Check Whenever Activated
227
Rinse/Drain Program - Automatic Start
227
Rinse/Drain Program - Automatic Switch off
228
Cleaning
229
Decalcification
229
Maintenance - the Flow Path
229
The Flow Path
229
Procedure
230
Ultrafilter - How to Change
230
Ultrafilter Replacement Reminder
230
Blood Leak Detector
232
Blood Pump
232
Maintenance - the Exterior
232
Pick-Up Tubes
232
The Exterior Surfaces
232
Top Tray
232
BPM Cuff
233
Technical Data and Specifications
234
Chapter 9 Technical Data and Specifications Contents
235
Performance and Specification - Control System
235
Blood Flow Control
235
Heparin Pump
236
Blood Pressure
236
Blood Pressure Monitor (BPM)
237
Dialysis Fluid Preparation
238
Proportioning of Concentrates
239
Ultrafiltration Control
239
Profiling
239
Diascan
240
Disinfection and Cleaning - Chemical Disinfection
241
Auto Heat Disinfection
242
Disinfection and Cleaning - Heat Disinfection
242
Disinfection and Cleaning - Exterior Cleaning
243
Disinfection and Cleaning - Rinse/Drain
243
Heat Disinfection Program Including WRO 300 H
243
Water Supply
244
Power Supply
245
Battery Back
246
Connection of External Equipment
246
Air Detection
247
Extracorporeal Blood Loss to the Environment
247
Performance and Specification - Supervisory System
247
Blood Leakage Detection
248
Dialysis Fluid Preparation
248
Ultrafiltration Supervision
248
Infusion Stand
249
Physical Data
249
Materials in Contact with Dialysis Fluid, Concentrates and Water
250
Metals
250
Others
250
Polymers
250
Electromagnetic Environment
251
Environmental Data
251
Operation
251
Operator's Manual - Technical Data 9:1
251
Transportation and Storage
251
Separation Distance According to Frequency of Transmitter
254
Standards
255
Major Changes in Operator's Manual
258
Major Changes between Program Version 2.XX and 3.XX
259
Index
261
Chapter 1
264
Before You Get Started - General
264
BPM – Blood Pressure Monitor
266
Chapter 11 BPM - Blood Pressure Monitor (Option) Contents
267
General
267
Patient Factors Which Affect Readings
269
BPM Log List
271
Single Measuring
272
Automatic - Interval Measuring
274
Automatic - Continuous Measuring
278
Procedure
278
HCEN12239 Revision 12.2010 AK 96 ® Operator's Manual - BPM 11:1
278
Application
284
How the Measuring Process Is Performed by the Machine
285
Glossary of Diascan Parameters and Key Terms
285
Precautions before Use
287
Menus
289
The Viewing Menu
289
Measurement Result Values Without Kt/V Measurement
289
Measurement Result Values, Kt/V Measurement Included
291
Time to Target
292
The Setting Menu
293
Activation/Deactivation and Measurement Mode Setting
293
Alarm Limit for Clearance
294
Distribution Volume
295
Distribution Volume Setting
295
Alarm Limit for Kt/V
297
Target for Kt/V
297
Alarms
299
Clearance Alarm Limit
299
Kt/V Alarm Limit
300
Step-By-Step Instructions for Measuring Clearance and Kt/V
301
Single Clearance Measurement Check
301
Continuous Measuring of Clearance
303
Single Kt/V and Clearance Measurement Check
305
Continuous Measuring of Kt/V and Clearance
308
Chapter 13 Alarms Contents
319
Alarms - Overview
319
Alarms - General
322
Alarm Indication
322
General Alarm Handling
322
Alarm History
324
How to Find the Alarm
325
Appears
325
Machine Actions
325
Alarm List
326
Arterial Pressure Alarms
326
Venous Pressure Alarms
331
Air Detector Alarm
336
Low Blood Flow Rate Alarm
339
Single Needle Stroke Volume Alarm
341
Blood Pressure Alarms
343
Blood Leak Alarm
351
TMP Alarms
354
Temperature Alarms
358
Conductivity Alarm
362
Ph (Option) Alarm
364
Connect Patient Alarm
366
Technical Alarm
368
Attention Alarms
372
Chapter 14 Attentionalarms Contents
373
Attention Alarms - General
373
Attention Alarm Indication
373
General Attention Alarm Handling
373
How to Find the Attention Alarm
375
Attention Alarm List
376
Air Leakage
377
Art Press Menu Has Been Closed
378
Change Has Been Executed
378
Art Pressure Limits too Wide
379
Attach Tubes to Safety Bypass
380
Battery Failure
382
Bicart HOLDER NOT CLOSED
383
Bicart HOLDER NOT INSTALLED
384
Bicart NOT ATTACHED to HOLDER
385
Blood Detected in Assisted Prim
386
Blood in Priming Detector
387
Blood Leak Detector Failure
388
Blood Path Menu Has Been Closed
389
Blood Path Pressure Test Failed
390
Blood Pump Door Not Closed
391
Blood Pump Overload
392
Blood Pump Overload in Fch
393
Blood Pump Stop Time Expired
394
Bpm Failure
395
Bpm Menu Has Been Closed
396
Central Chem Disinf. Completed
397
Check Rotor/Tube Distance
398
Chemical Fillup Not Sufficient
399
Cleancart FILL COMPLETED
400
Cleancart NOT ATTACHED to HOLDER
401
Cleaning Required
402
Clearance too LOW
403
Connect Concentrate When Time to Prepare Machine for Treatment
404
Decalcification Required
405
Dialysis Fluid Flow too Low
406
Dialysis Fluid Not Ready for Treatment
407
Dialysis Fluid Ready
408
Diascan FAILURE
409
Turn off Diascan
409
Diascan Is Not Restarted
410
Diascan MEASUREMENT FAILED
411
Diascan NOT POSSIBLE During
412
Diascan PAUSED
413
Diascan RESCHEDULED TWICE
415
Disconnect Arterial Pressure
417
Disconnect Venous Pressure
418
Disinfection in PROGRESS
419
Disinfection Required
420
Fch Is Waiting
421
Fluid Path Menu Has Been Closed
426
Fluid Path Obstruction
427
Fluid Tube Sensor Test
428
Fluid Tube Sensor Test Failed
429
Fluid Tubes in Safety Bypass
431
Mute Time
432
Buzzer Sound
432
Fluid Tubes Not in Safety Bypass
433
Fluid Path Obstruction During Disinfection
434
Function Check Prolonged Due to Power Failure
435
Function Check Prolonged Due to Wro
436
Function Check Restarted
437
Heater Efficiency Not Sufficient
438
Heparin Flow Rate Set to Zero
439
Heparin Pump Overload
440
HCO3- Setting Has Been Changed
441
High Conductivity Not Obtained
442
High Inlet Water Cond.
443
High Monitor Temperature Alarm
445
Turn off the Monitor
445
High Venous Press Test Not Made
446
Impossible Auto Start Setting
447
Check Auto Heat/Rinse Ready Time
447
Impossible Time or Uf Setting
448
Adjust TIME or UFV
448
Improper Position of Chemical Disinfectant Connector
449
Improper Position of Pick up
450
Incorrect Acidic Concentrate
452
Check Concentrate
452
Incorrect Bicarb. Concentrate
453
Incorrect Concentrate
454
Incorrect Dia Fluid Composition
455
Incorrect Language Selection
456
Insufficient Inlet Pressure
457
Kt/V FORECAST too LOW
458
Kt/V TARGET REACHED
459
Low Battery Power
460
Machine Turns off Within One Min
460
Low Flow Heat Aborted
461
Low Flow Heat Not Avail. in Wro
462
Na+ Setting Has Been Changed
463
Negative Uf Rate
464
New Ultra Filter Required
465
No Backfiltration Warning
468
No Bpm Values
469
Check BPM Cuff
469
No Change in Blood Pressure
470
Check Cause, Press BLOODPUMP Btn
470
No Cuff Attached
471
Attach or Check BPM Cuff
471
Power Failure, Battery Operation
472
Battery Operated for $# Minutes
472
Press SELECT Key to Enter
473
BPM History List
473
Press SELECT to Enter
474
Diascan Log List
474
Priming Volume Limit Achieved
475
Check Blood Line
475
Profiling Is Not Restarted
476
Check Settings and Activate
476
Recovered from Power Failure
477
Press SELECT Key to Confirm
477
Pv and Qd Setting in Conflict
478
Increase Qd to 500 Ml/Min
478
Remove Tubes from Safety Bypass
479
Rinse/Dis Menu Has Been Closed
480
Sags Test Failed
481
Check Water Supply
481
Set Dia Fluid Flow Not Reached
482
Readjust Flow or Call Service
482
Start Heat in WRO
483
Start Low Flow Heat in WRO
484
Time Menu Has Been Closed
485
Tmp Limits too Wide
486
To End Treatment, Zero Time in Isolated UF
487
To Obtain Total UFV
488
ISOL UF Must be Started
488
To Start the Air Detector Test
489
Too High Tmp Required
490
Increase Time or Decrease UFV
490
Treatment Time Expired
491
Treatment will Stop in 2 Minutes
492
Uf Rate Limit Reached
493
Uf Volume Achieved too Early
494
Uf Rate Lower than Minimum Set
495
Adjust TIME, UFV or MIN UF
495
UFR Setting Has Been Changed
496
Uf Rate Stopped Due to High Pv
497
Lower PV
497
Uf Stop Time Expired
498
Press UF START/STOP Button
498
Uf Volume Set to Zero
499
Ven Press Menu Has Been Closed
500
VENOUS LOW LIMIT below +10 Mmhg
501
Venous Pressure Limits too Wide
502
Wait 30 Seconds to Bypass Dialysis Fluid
503
Wro Communication Failure
504
Check WRO
504
Wro Not Ready
505
Wrong Disinfectant Agent
506
5
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Gambro AK 96 Specifications
General
Brand
Gambro
Model
AK 96
Category
Medical Equipment
Language
English
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