Gambro AK-98 User manual

AK 98 Dialysis Machine

Operator’s Manual

Program version 2.xx

Order number:

MHCEN12745-10/16

Trademarks

AK 98, BiCart, CleanCart, Diascan, Evodial, Gambro, Polyflux, Revaclear, SoftPac and U9000 are trademarks of Baxter International Inc. or its subsidiaries.

Dialox is a trademark of Bioxal.

Hastelloy is a trademark of Haynes International Inc.

Manufacturer

Gambro Lundia AB

Box 10101 Magistratsvägen 16

SE-220 10 LUND

Sweden

Phone [phone]

www.baxter.com

Questions or comments about this publication can be directed to your local representative or to the manufacturer.

HCEN12745 Revision 10.2016

Program version 2.xx

Operators handbook

1	Before you get started .........................................................................................................	A:9
2	Machine Description ..........................................................................................................	A:27
3	Handling the dialysis machine..........................................................................................	A:51
4	Haemodialysis - Double needle treatment .......................................................................	A:75
5	Haemodialysis - Single needle treatment ......................................................................	A:105
6	Isolated ultrafiltration.......................................................................................................	A:113
7	Profiling.............................................................................................................................	A:117
8	Measuring blood pressure ..............................................................................................	A:127
9	DIASCAN ...........................................................................................................................	A:135
10	Disinfection and cleaning................................................................................................	A:143
11	Disinfection with the AK 98 dialysis machine and WRO system.................................	A:159
12	IT Connectivity..................................................................................................................	A:165
13	Maintenance handling......................................................................................................	A:171
14	Technical data and specifications ..................................................................................	A:177
15	Local regulatory registration (if applicable) ..................................................................	A:195
Alarm handbook
1	Alarms ...................................................................................................................................	B:9
2	Attentions............................................................................................................................	B:69

HCEN12745 Revision 10.2016 Program version 2.xx

Table of contents

1	Before you get started .........................................................................................................		A:9
	1.1 Important while reading the operator’s manual ...................................................		A:10
	1.1.1	About this operator´s manual ...............................................................................	A:10
	1.1.2	Safety definitions ..................................................................................................	A:10
	1.1.3	Values and settings ..............................................................................................	A:10
	1.1.4	Buttons .................................................................................................................	A:10
	1.1.5	About the screen ..................................................................................................	A:11
	1.1.6	Symbols................................................................................................................	A:12
	1.2 General warning and precautions before use ......................................................		A:15
	1.2.1	General precautions before use ...........................................................................	A:15
	1.2.2	Responsibility and disclaimer ...............................................................................	A:17
	1.2.3	Leakage current and potential equalisation connection .......................................	A:18
	1.2.4	Treatment location................................................................................................	A:18
	1.2.5	Central venous catheter .......................................................................................	A:18
	1.2.6	Connection of external electrical equipment.........................................................	A:18
	1.2.7	How to move the AK 98 dialysis machine ............................................................	A:18
	1.2.8	Safety philosophy .................................................................................................	A:19
	1.3	Intended use ............................................................................................................	A:19
	1.3.1	Intended use.........................................................................................................	A:19
	1.3.2	Training.................................................................................................................	A:20
	1.3.3	Disinfection and functional check .........................................................................	A:20
	1.3.4	Inlet water requirements .......................................................................................	A:21
	1.3.5	Hygienic quality of central delivery systems .........................................................	A:21
	1.3.6	Preparing dialysis fluid..........................................................................................	A:21
	1.4	Accessories .............................................................................................................	A:21
	1.4.1	Concentrates, chemical disinfectants, accessories and disposables ...................	A:21
	1.4.2	Concentrates ........................................................................................................	A:22
	1.4.3	Chemical disinfectants..........................................................................................	A:22
	1.4.4	Blood lines ............................................................................................................	A:23
	1.4.5	Accessories ..........................................................................................................	A:23
	1.4.6	Ultrafilter ...............................................................................................................	A:24
	1.4.7	Dialyzers...............................................................................................................	A:24
	1.4.8	Blood pressure measurement accessories ..........................................................	A:24
	1.5	Glossary ...................................................................................................................	A:25
	1.5.1	Glossary ...............................................................................................................	A:25
2	Machine Description ..........................................................................................................		A:27
	2.1	Blood part.................................................................................................................	A:28
	2.1.1	Blood part components.........................................................................................	A:28
	2.1.2	Blood part component details ...............................................................................	A:29
	2.2	Fluid part ..................................................................................................................	A:36
	2.2.1	Fluid part components ..........................................................................................	A:36
	2.2.2	Fluid part component details ................................................................................	A:37

HCEN12745 Revision 10.2016

Program version 2.xx

	2.3	Rear component ......................................................................................................		A:44
	2.3.1		Rear components .................................................................................................	A:44
	2.3.2		Rear component details........................................................................................	A:45
3	Handling the dialysis machine..........................................................................................			A:51
	3.1	Operator's position..................................................................................................		A:53
	3.1.1		Operator's position ...............................................................................................	A:53
	3.2 Switch the dialysis machine on and off ................................................................			A:53
	3.2.1		Main switch...........................................................................................................	A:53
	3.2.2		On/off button.........................................................................................................	A:53
	3.3 Indication light and buttons ...................................................................................			A:54
	3.3.1		Indication light.......................................................................................................	A:54
	3.3.2		Buttons on the operator´s panel ...........................................................................	A:54
	3.4	The screen................................................................................................................		A:55
	3.4.1		Screen overview ...................................................................................................	A:55
	3.4.2		Venous and arterial pressure controls (1, 2).........................................................	A:56
	3.4.3		Machine state indicator (3) ...................................................................................	A:57
	3.4.4		Time (4) ................................................................................................................	A:57
	3.4.5		Blood path (5) .......................................................................................................	A:57
	3.4.6		Fluid path (6) ........................................................................................................	A:58
	3.4.7		Bypass path..........................................................................................................	A:58
	3.4.8		Blood pressure area (7, 8)....................................................................................	A:58
	3.4.9		Diascan read out field and Diascan button (9, 10) ...............................................	A:58
	3.4.10		Treatment overview (11–15) .................................................................................	A:58
	3.4.11		Alarm tab (16).......................................................................................................	A:59
	3.4.12		Information tab (17) ..............................................................................................	A:59
	3.4.13		Treatment graph tab (18)......................................................................................	A:59
	3.4.14		Information field (19).............................................................................................	A:59
	3.4.15		Patient page (20) ..................................................................................................	A:60
	3.4.16		Priming button (21) ...............................................................................................	A:60
	3.4.17		Rinse back button (22) .........................................................................................	A:60
	3.4.18		Disinfection button (23).........................................................................................	A:61
	3.4.19		Blood button (24) ..................................................................................................	A:62
	3.4.20		Fluid button (25) ...................................................................................................	A:64
	3.4.21		Fluid bypass button (26) .......................................................................................	A:66
	3.4.22		Ultrafiltration button (27) .......................................................................................	A:66
	3.4.23		Treatment history page (28) .................................................................................	A:66
	3.4.24		Status bar (29)......................................................................................................	A:68
	3.4.25		Service menu........................................................................................................	A:68
	3.5	Concentrate standby mode ....................................................................................		A:70
	3.5.1		About concentrate standby mode.........................................................................	A:70
	3.5.2		To manually activate concentrate standby mode..................................................	A:70
	3.5.3		To resume preparation of dialysis fluid .................................................................	A:70
	3.5.4		To automatically enter concentrate standby mode ...............................................	A:71

HCEN12745 Revision 10.2016 Program version 2.xx

	3.6	Operate the machine during power failure ...........................................................		A:71
	3.6.1		Power failure with battery back-up .......................................................................	A:71
	3.6.2		Power failure without battery back-up ..................................................................	A:71
	3.6.3		Return the blood to the patient manually..............................................................	A:71
	3.7	Change of dialyzer and blood lines during treatment..........................................		A:72
	3.8	Change of BICART cartridge during Treatment....................................................		A:73
	3.9	The ultrafiltration control........................................................................................		A:73
4	Haemodialysis - Double needle treatment .......................................................................			A:75
	4.1	Basic functionality...................................................................................................		A:76
	4.2	Start a double needle treatment ............................................................................		A:76
	4.2.1		Check before treatment ........................................................................................	A:76
	4.2.2		Start functional check ...........................................................................................	A:76
	4.2.3		Set up the dialysis machine..................................................................................	A:77
	4.2.4		Attach the arterial blood line .................................................................................	A:79
	4.2.5		Attach the venous blood line ................................................................................	A:84
	4.2.6		Attach the heparin syringe....................................................................................	A:89
	4.2.7		Priming the dialysis circuit ....................................................................................	A:91
	4.2.7.1		Priming description ...........................................................................................	A:91
	4.2.7.2		Manual priming .................................................................................................	A:91
	4.2.7.3		Assisted priming ...............................................................................................	A:93
	4.2.8		Priming options.....................................................................................................	A:94
	4.2.8.1		Extra priming ....................................................................................................	A:94
	4.2.8.2		Recirculation.....................................................................................................	A:94
	4.2.9		Set treatment time ................................................................................................	A:95
	4.2.10		Set ultrafiltration volume .......................................................................................	A:95
	4.2.11		Set heparin values................................................................................................	A:96
	4.2.12		Connect the patient ..............................................................................................	A:97
	4.2.13		Start the treatment................................................................................................	A:99
	4.3	End a double needle treatment ............................................................................		A:100
	4.3.1		End the treatment ...............................................................................................	A:100
	4.3.2		Confirm disconnect patient ................................................................................	A:101
	4.3.3		Machine aftercare...............................................................................................	A:101
5	Haemodialysis - Single needle treatment ......................................................................			A:105
	5.1	Basic functionality.................................................................................................		A:106
	5.2	Preparations...........................................................................................................		A:106
	5.3	Connect the patient ...............................................................................................		A:109
	5.4	Start the treatment..................................................................................................		A:110
	5.5	End a single needle treatment...............................................................................		A:112

HCEN12745 Revision 10.2016

Program version 2.xx

6	Isolated ultrafiltration.......................................................................................................		A:113
	6.1	Basic functionality..................................................................................................	A:114
	6.2	Handling isolated ultrafiltration ............................................................................	A:114
	6.2.1	Activate isolated ultrafiltration.............................................................................	A:114
	6.2.2	How to add a second and subsequent phase of isolated UF .............................	A:115
	6.2.3	Deactivate isolated ultrafiltration.........................................................................	A:115
	6.3	Additional information ...........................................................................................	A:115
	6.3.1	Heparin ...............................................................................................................	A:115
7	Profiling.............................................................................................................................		A:117
	7.1	General ....................................................................................................................	A:118
	7.2	Profiling of sodium and bicarbonate concentrations .........................................	A:118
	7.3	Profiling of ultrafiltration rate................................................................................	A:119
	7.4	Profiling setting/activation ...................................................................................	A:122
	7.5	Profiling without a preset model..........................................................................	A:122
	7.5.1	Profiling ultrafiltration without a preset model.....................................................	A:122
	7.5.2	Profiling sodium without a preset model.............................................................	A:123
	7.5.3	Profiling bicarbonate without a preset model......................................................	A:124
	7.6	Set and activate profiling with a preset model ...................................................	A:125
8	Measuring blood pressure ..............................................................................................		A:127
	8.1	Blood pressure monitor (BPM) ............................................................................	A:128
	8.2	Blood pressure cuff...............................................................................................	A:128
	8.3	Direct blood pressure measuring ........................................................................	A:130
	8.4	Interval blood pressure measuring......................................................................	A:130
	8.5	Measurement history ............................................................................................	A:131
	8.6	Set alarm limits ......................................................................................................	A:131
	8.7	Patient care during blood pressure measuring..................................................	A:132
	8.7.1	All patients ..........................................................................................................	A:132
	8.7.2	Patients with high blood pressure.......................................................................	A:133
	8.7.3	Patients with arrhythmia .....................................................................................	A:134
9	DIASCAN ...........................................................................................................................		A:135
	9.1	How DIASCAN function works .............................................................................	A:136
	9.2	What DIASCAN function checks ..........................................................................	A:136
	9.3	Check K and Kt ......................................................................................................	A:136
	9.4	Check Kt/V..............................................................................................................	A:137
	9.5	Measurement history ............................................................................................	A:138
	9.6	Set a Kt/V target value...........................................................................................	A:139

HCEN12745 Revision 10.2016 Program version 2.xx

9.7 Set an alarm for low K or Kt/V ..............................................................................			A:140
9.8 Factors that affect measuring ..............................................................................			A:140
10 Disinfection and cleaning................................................................................................			A:143
10.1 Disinfection and cleaning – general ....................................................................			A:144
10.2 Check before you start..........................................................................................			A:144
10.3	Heat disinfection....................................................................................................		A:145
10.3.1		Description of heat disinfection...........................................................................	A:145
10.3.2		Cleaning and decalcification...............................................................................	A:145
10.3.3		Start a heat disinfection ......................................................................................	A:146
10.3.4		Start a heat disinfection with a CLEANCART cartridge......................................	A:146
10.3.5		Start a heat disinfection with liquid citric acid .....................................................	A:146
10.3.6		Start a short heat disinfection with liquid citric acid ............................................	A:147
10.3.7		Integrated heat disinfection ................................................................................	A:147
10.3.7.1 Integrated heat disinfection ............................................................................			A:147
10.3.7.2 To schedule a heat disinfection program ........................................................			A:147
10.3.7.3 To turn off a scheduled program.....................................................................			A:148
10.3.8		Integrated heat disinfection with a WRO 300 H unit...........................................	A:149
10.3.8.1 Integrated heat disinfection with a WRO 300 H unit.......................................			A:149
10.4	Chemical disinfection ...........................................................................................		A:149
10.4.1		About chemical disinfection ................................................................................	A:149
10.4.2		Start a chemical disinfection...............................................................................	A:149
10.4.3		Start a central chemical disinfection ...................................................................	A:150
10.4.4		Chemical disinfection program with a WRO unit ................................................	A:151
10.4.5		Test for disinfectant residues ..............................................................................	A:151
10.4.6		Disinfection history .............................................................................................	A:152
10.4.7		About chemical disinfectants ..............................................................................	A:152
10.5	Rinse and Drain .....................................................................................................		A:153
10.5.1		Start rinse or drain ..............................................................................................	A:153
10.5.2		To schedule a rinse program ..............................................................................	A:153
10.5.3		To turn off rinse program for a certain day..........................................................	A:154
10.6 Machine storage with chemical disinfectant ......................................................			A:154
10.6.1		Fill the dialysis machine with chemical disinfectant............................................	A:154
10.6.2		Start using a dialysis machine filled with chemical disinfectant..........................	A:155
10.7	Reference ...............................................................................................................		A:156
10.7.1		Disinfection, Decalcification and Cleaning Agents - Characteristics ..................	A:156
10.7.2		Cleaning and disinfection schedule ....................................................................	A:156
10.7.3		Flow path ............................................................................................................	A:157
11 Disinfection with the AK 98 dialysis machine and WRO system.................................			A:159
11.1	General description...............................................................................................		A:160
11.2 Integrated heat disinfection with a WRO 300 H unit ..........................................			A:160
11.2.1		Description of integrated heat disinfection with a WRO 300 H unit ....................	A:160
11.2.2		Schedule an integrated heat disinfection............................................................	A:160
11.2.3		Start an integrated heat disinfection manually....................................................	A:160

HCEN12745 Revision 10.2016

Program version 2.xx

	11.3	Central chemical disinfection program with a WRO unit ..................................		A:161
	11.3.1		Description of central chemical disinfection program with a WRO unit ..............	A:161
	11.3.2		Start a central chemical disinfection with a WRO unit ........................................	A:161
	11.4	Settings for rinse ...................................................................................................		A:163
	11.4.1		Rinse settings .....................................................................................................	A:163
12	IT Connectivity..................................................................................................................			A:165
	12.1	Basic functionality.................................................................................................		A:166
	12.2	Confirmed Patient ID and retrieval of patient prescription when the Patient ID
			is confirmed .......................................................................................................	A:166
	12.3	Cancel prescription retrieval ................................................................................		A:168
	12.4	Clearing Patient ID and patient prescription.......................................................		A:168
	12.5	Setting treatment parameters manually ..............................................................		A:169
	12.6	Setting Station ID...................................................................................................		A:169
	12.7	Unconfirmed patient with data transfer only ......................................................		A:170
13	Maintenance handling......................................................................................................			A:171
	13.1	Maintenance...........................................................................................................		A:172
	13.2	Blood Pump Rotor.................................................................................................		A:172
	13.2.1		Maintenence of the blood pump rotor.................................................................	A:172
	13.2.2		Clean the blood pump rotor ................................................................................	A:172
	13.3	Clean the blood leak detector ..............................................................................		A:173
	13.4	Water inlet tube......................................................................................................		A:173
	13.5	Pick-up tubes .........................................................................................................		A:173
	13.6	Surface ...................................................................................................................		A:174
	13.7	Change ultrafilter...................................................................................................		A:174
	13.8	Storage ...................................................................................................................		A:175
	13.9	Service....................................................................................................................		A:175
	13.10	Disposal..................................................................................................................		A:176
14 Technical data and specifications ..................................................................................				A:177
	14.1	Performance and specification - Control System ..............................................		A:178
	14.1.1		Blood flow control ...............................................................................................	A:178
	14.1.2		Heparin pump .....................................................................................................	A:178
	14.1.3		Blood pressure ...................................................................................................	A:178
	14.1.4		Blood pressure monitor (BPM) ...........................................................................	A:178
	14.1.5		Dialysis fluid preparation ....................................................................................	A:179
	14.1.6		Ultrafiltration control............................................................................................	A:180
	14.1.7		Ultrafiltration protective.......................................................................................	A:180
	14.1.8		Profiling...............................................................................................................	A:180
	14.1.9		DIASCAN function ..............................................................................................	A:180
	14.1.10		Disinfection and cleaning – chemical disinfection ..............................................	A:180

HCEN12745 Revision 10.2016 Program version 2.xx

14.1.11		Disinfection and cleaning - heat disinfection ......................................................	A:181
14.1.12		Auto heat disinfection .........................................................................................	A:182
14.1.13		Heat disinfection program including WRO 300 H ...............................................	A:182
14.1.14		Disinfection and cleaning – rinse/drain...............................................................	A:182
14.1.15		Disinfection and cleaning – exterior cleaning .....................................................	A:183
14.1.16		Water supply.......................................................................................................	A:183
14.1.17		Power supply ......................................................................................................	A:183
14.1.18		Network connection ............................................................................................	A:184
14.1.19		Connection of external equipment......................................................................	A:184
14.1.20		Battery back-up ..................................................................................................	A:185
14.2 Performance and specification - Supervisory system.......................................			A:185
14.2.1		Blood pressure supervision ................................................................................	A:185
14.2.2		Air detection........................................................................................................	A:185
14.2.3		Extracorporeal blood loss due to coagulation.....................................................	A:186
14.2.4		Dialysis fluid preparation ....................................................................................	A:186
14.2.5		TMP ....................................................................................................................	A:186
14.2.6		Blood leakage detection .....................................................................................	A:186
14.3	Alarm sound pressure ..........................................................................................		A:186
14.3.1		Alarm sound pressure ........................................................................................	A:186
14.4	Physical data..........................................................................................................		A:186
14.4.1		Dimensions and weight ......................................................................................	A:186
14.4.2		Infusion stand .....................................................................................................	A:187
14.5 Materials in contact with dialysis fluid, concentrates, and water ....................			A:187
14.5.1		Polymers.............................................................................................................	A:187
14.5.2		Metals .................................................................................................................	A:187
14.5.3		Other materials ...................................................................................................	A:187
14.6	Environmental data ...............................................................................................		A:188
14.6.1		Operation............................................................................................................	A:188
14.6.2		Transportation and storage ................................................................................	A:188
14.6.3		Electromagnetic environment .............................................................................	A:188
14.6.4		Expected service life...........................................................................................	A:191
14.6.5		Energy and water consumption ..........................................................................	A:192
14.7	Standards ...............................................................................................................		A:192
15 Local regulatory registration (if applicable) ..................................................................			A:195

HCEN12745 Revision 10.2016

Program version 2.xx

1	Before you get started
	1.1 Important while reading the operator’s manual ...................................................		A:10
	1.1.1	About this operator´s manual ...............................................................................	A:10
	1.1.2	Safety definitions ..................................................................................................	A:10
	1.1.3	Values and settings ..............................................................................................	A:10
	1.1.4	Buttons .................................................................................................................	A:10
	1.1.5	About the screen ..................................................................................................	A:11
	1.1.6	Symbols................................................................................................................	A:12
	1.2 General warning and precautions before use ......................................................		A:15
	1.2.1	General precautions before use ...........................................................................	A:15
	1.2.2	Responsibility and disclaimer ...............................................................................	A:17
	1.2.3	Leakage current and potential equalisation connection .......................................	A:18
	1.2.4	Treatment location................................................................................................	A:18
	1.2.5	Central venous catheter .......................................................................................	A:18
	1.2.6	Connection of external electrical equipment.........................................................	A:18
	1.2.7	How to move the AK 98 dialysis machine ............................................................	A:18
	1.2.8	Safety philosophy .................................................................................................	A:19
	1.3	Intended use ............................................................................................................	A:19
	1.3.1	Intended use.........................................................................................................	A:19
	1.3.2	Training.................................................................................................................	A:20
	1.3.3	Disinfection and functional check .........................................................................	A:20
	1.3.4	Inlet water requirements .......................................................................................	A:21
	1.3.5	Hygienic quality of central delivery systems .........................................................	A:21
	1.3.6	Preparing dialysis fluid..........................................................................................	A:21
	1.4	Accessories .............................................................................................................	A:21
	1.4.1	Concentrates, chemical disinfectants, accessories and disposables ...................	A:21
	1.4.2	Concentrates ........................................................................................................	A:22
	1.4.3	Chemical disinfectants..........................................................................................	A:22
	1.4.4	Blood lines ............................................................................................................	A:23
	1.4.5	Accessories ..........................................................................................................	A:23
	1.4.6	Ultrafilter ...............................................................................................................	A:24
	1.4.7	Dialyzers...............................................................................................................	A:24
	1.4.8	Blood pressure measurement accessories ..........................................................	A:24
	1.5	Glossary ...................................................................................................................	A:25
	1.5.1	Glossary ...............................................................................................................	A:25

HCEN12745 Revision 10.2016 Program version 2.xx

AK 98 Dialysis Machine - Before you get started

A:9

1.1Important while reading the operator’s manual

1.1.1About this operator´s manual

This operator’s manual provides instructions necessary for the proper operation of the AK 98 dialysis machine. It is not a guide for the administration of haemodialysis.

1.1.2Safety definitions

Warning

WARNING!

A warning alerts the reader about a situation which, if not avoided, could result in an adverse reaction, injury or death.

Caution

CAUTION!

A caution alerts the reader about a situation which, if not avoided, could result in minor or moderate injury to the user or patient or damage to the equipment or other property.

Note

NOTE!

Notes are added to give more information.

1.1.3Values and settings

Parameter values are set by the operator. For example treatment time and some alarm limits. See Section 1.1.5 “About the screen” on page A:11. All values and settings in this operator’s manual are default values, which are set when the dialysis machine is manufactured. Check with the authorised service technician responsible for installing the dialysis machine if there are any values that are changed from the default settings.

Preset

When this symbol appears in the manual text, it indicates the possibility to preset the value of a parameter. Such a preset is done to adapt the settings of the machine to correspond with the routines of the user/clinic or specific patient prescription. A preset change shall always be done by an authorised service technician. For example, it is possible to preset the machine for which mode to start up in, some alarm limits, some functions and options. An authorised service technician shall, together with the user, confirm that the presets have been properly set.

1.1.4Buttons

The buttons on the operator's panel, to the right of the screen, light up in different situations to guide the operator or to inform of actual status. See Figure 1-1 “The operator´s panel” on page A:11. The illustrations in the handling instructions do not normally show if the button is lit or unlit; the button figures are the same for lit, flashing and unlit buttons.

The buttons on the screen can be lit, disabled or flashing depending on the status and action but in this manual this state of the button is not reflected in the text or picture.

A:10	AK 98 Dialysis Machine - Before you get started

HCEN12745 Revision 10.2016

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1.1.5About the screen

The operator´s panel of the AK 98 dialysis machine has a colour touch screen. The screen allows the operator to interact with the dialysis machine by pressing various buttons.

Figure 1-1. The operator´s panel

Press a button or menu item to activate its function.

Select a tab to reach the settings. The UF rate tab is selected in this picture.

Press a setting to adjust it. For example UF volume.

Use the keypad to adjust numeric values. The keypad will open automatically when needed.

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1.1.6Symbols

The symbols can be affixed to the machine or affixed/printed on the original packaging.

Alternating current

Protective earth (ground)

Off (disconnection from the mains power)

On (connection to the mains power)

Equipotential connector

The AK 98 dialysis machine is protected against solid foreign objects ≥12.5 mm Ø and vertically falling water drops.

Type B, applied part

NIBP type BF applied part

The product does not contain latex. The symbol frame and text are white.

The product does not contain PVC. The symbol frame and text are white.

The maximum stacking load permitted on the transport package

Fragile – Handle with care

This way up

Keep dry

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Catalogue number

Serial number

Humidity limitation. Upper and lower limit is expressed with numeric values in %.

Atmospheric pressure limitation. Upper and lower limit is expressed with numeric values in kPa.

Temperature limitation. Upper and lower limit is expressed with numeric values in degree Celsius or Fahrenheit.

Manufacturer. The date of manufacture as well as the name and address of the manufacturer are included in the symbol.

Recycling symbol – Corrugated Cardboard. According to GB 18455–2001.

This symbol indicates that the dialysis machine contains toxic or hazardous substances or elements according to GB/T26572-2011. The number 25 indicates the corresponding environmental protection use period of the dialysis machine.

Separate collection for electrical and electronic equipment

Warning, dangerous voltage. Contact may cause electric shock or burn. The symbol colour is black on a yellow background.

Warning. Do not lean the AK 98 dialysis machine more than 5° from the horizontal plane. The symbol colour is black on a yellow background.

Do not lean or push the AK 98 dialysis machine. Risk for overbalance. The symbol colours are red, white, and black.

The weight of the AK 98 dialysis machine including equipment used for the treatment placed on the machine.

Caution, consult accompanying documents

Read instructions before use. The symbol colour is white on a blue background.

The following symbols are found on the cuff:

Index Line

Artery symbol and arrow should be placed over brachial or femoral artery.

Symbol indicating arm circumference.

Cuff index line must fall within range markings.

The following symbols are found on the BICART cartridge holder:

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Shows where the top port of the BICART and CLEANCART cartridges connects with the upper arm during cartridge installation.

A guide to ensure the correct upright positioning of the BICART and CLEANCART cartridges during its installation.

Cuff ranges/colours

Table 1-1. Cuff ranges/colours

Number:	Size:	Colour:	Range:
1	Thigh	Brown	38-50 cm
2	Lg Adult Long	Burgundy	31-40 cm
3	Lg Adult	Burgundy	31-40 cm
4	Adult Long	Navy Blue	23-33 cm
5	Adult	Navy Blue	23-33 cm
6	Sm Adult Long	Royal Blue	17-25 cm
7	Sm Adult	Royal Blue	17-25 cm
8	Child Long	Green	12-19 cm
9	Child	Green	12-19 cm
10	Infant	Orange	8-13 cm

Certification marks

CE marking

The CE conformity mark indicates that the AK 98 dialysis machine conforms to the requirements in the EC Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices. It also indicates that the notified body British Standards

Institution (BSI, No. 0086) has approved the Quality Management System. The CE conformity mark is only valid for the AK 98 dialysis machine. Disposables and any accessories specified for use with the AK 98 dialysis machine are marked with CE conformity marks in their own right.

CSA marking

The CSA mark indicates that the AK 98 dialysis machine conforms to the requirements related to safety of medical devices for Canada and that the AK 98 dialysis machine has been evaluated to the applicable CSA standards for use in Canada.

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HCEN12745 Revision 10.2016

Program version 2.xx

1.2General warning and precautions before use

1.2.1General precautions before use

WARNING!

Unauthorised modifications, alterations or repair and lack of maintenance or calibration of the AK 98 dialysis machine may result in malfunctioning or have other serious consequences for the safe operation of the equipment.

WARNING!

The mains power cable from the AK 98 dialysis machine (cable length is 3.5 metres) shall be connected to a socket with protected earth (PE) to avoid risk of electrical shock.

WARNING!

To minimise the risk of arrhythmia due to leakage currents when a central venous catheter is used, and the tip of the catheter is close to the heart, it is necessary to connect the potential equalisation conductor between the AK 98 dialysis machine and the potential equalisation busbar in the electrical installation.

WARNING!

To minimise the risk of arrhythmia due to leakage currents from other electrical equipment when a central venous catheter is used, and the tip of the catheter is close to the heart, any equipment within the patient area shall have leakage current values below respective limit required by CF type applied parts.

WARNING!

To protect the children, never leave children unattended near the dialysis machine, its chemicals, disposables or accessories.

WARNING!

To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

WARNING!

Never use multiple socket-outlet when connecting the dialysis machine or WRO 300 to mains supply since it might lead to too high leakage currents during fault conditions.

WARNING!

Do not use the AK 98 dialysis machine adjacent to or stacked with other equipment, other than specified by the manufacturer.

WARNING!

Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

WARNING!

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) shall not be used no closer than 30 cm (12 inches) to any part of the ME EQUIPMENT, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could be the result.

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CAUTION!

To avoid improper handling, the AK 98 dialysis machine may only be operated by persons trained in haemodialysis and who have studied the instructions in this manual. The user/operator should draw special attention towards the text valid for the safety philosophy of the machine. See Section 1.2.8 “Safety philosophy” on page A:19. Verify that the first digit of the program version of both the machine and the manual is the same. If the AK 98 dialysis machine does not perform as described in this manual, it should not be used until the condition is rectified.

CAUTION!

When unpacking, check the equipment for any signs of damage. If the equipment is in any way damaged, proper operation cannot be assured.

CAUTION!

Patients connected to the AK 98 dialysis machine should be monitored by competent personnel since life threatening situations can arise that may not activate alarms. The operator should pay attention to all appropriate alarms and follow the instructions, warnings, cautions, and notes given in this manual. It is imperative that the machine has passed the functional check before connecting a patient.

CAUTION!

To ensure proper functionality, all calibration checks must be completed during installation before the machine is used for dialysis treatment.

CAUTION!

The AK 98 dialysis machine needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information in Section 14.6.3 “Electromagnetic environment” on page A:188.

CAUTION!

The use of mobile telephones or communication equipment in the vicinity of the AK 98 dialysis machine could adversely influence the performance of the machine. For further information, see Section 14 “Technical data and specifications” on page A:177.

CAUTION!

The AK 98 dialysis machine will perform as designed only if it is used and maintained in accordance with Baxter’s instructions. Any warranties made by Baxter with respect to the AK 98 dialysis machine are void if the equipment is not used in accordance with the instructions provided. Baxter will not accept responsibility for any damage or injury resulting from improper use or maintenance or unauthorised repair.

CAUTION!

To ensure proper functionality preventive inspection, maintenance and calibration of the AK 98 dialysis machine shall be performed by a fully trained authorised service technician according to the maintenance manual in the AK 98 Service manual which can be ordered from your Baxter representative. It is mandatory for preventive maintenance to be performed at least every other year. Yearly maintenance is recommended. The interval between preventive maintenance procedures might differ due to operating environment variations.

CAUTION!

Check the use environment before use as the AK 98 dialysis machine is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.

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CAUTION!

Make sure that any used chemical disinfectants are stored according to manufacturer’s recommendations.

CAUTION!

Make sure not to position the AK 98 dialysis machine in a way that it becomes difficult to operate the mains power switch.

NOTE!

The AK 98 dialysis machine must be installed according to the Installation guide.

NOTE!

For accuracy ranges written as ”(±1 mL/min or ±1%)”, the widest range is valid.

NOTE!

It is recommended that the equipment is kept in its original packing during transportation and storage.

NOTE!

The service manual is only available for the authorised service technician.

NOTE!

It is important that the protective earth in the installation is of high quality.

NOTE!

For the purpose of protecting the environment the AK 98 dialysis machine shall be separately collected for dismantling and recovery. Where applicable, national regulations shall be applied. Consult your local Baxter distributor for information.

NOTE!

To protect the machine against spillage, the infusion stand must always be correctly mounted in the machine.

NOTE!

The WRO unit (WRO 300 or WRO 300 H) must be preset by an authorised service technician to work correctly with the dialysis machine.

1.2.2Responsibility and disclaimer

The manufacturer accepts responsibility for the safety, reliability, and performance of this equipment only if the following conditions are fulfilled:

●Installation, operational procedures, maintenance, calibrations and repairs are carried out by appropriately trained and suitable qualified people.

●All equipment modifications are authorised in writing by the manufacturer and carried out by appropriately trained and suitable qualified people.

●The electrical installation of the relevant room complies with all applicable local electrical codes and, if applicable, IEC requirements.

●The equipment is used in accordance with the published operator’s manual.

Baxter does not accept any responsibility or liability for use of accessories or disposables other than those specified in this manual or if any specified accessory or disposable is not used in accordance with this manual, online instructions and the instructions for use accompanying those accessories and disposables.

The patient’s physician is responsible for counselling, home care follow-up and medical maintenance that comes with the treatment. Baxter has no responsibility for any of these activities.

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1.2.3Leakage current and potential equalisation connection

Definitions

Leakage current	Electrical current that leaks out of the intended circuit
	or current that is not functional.
Potential equalisation connection	A connection between the potential equalisation
	connector of the machine and the potential
	equalisation busbar of the electrical installation using
	a potential equalisation conductor. This connection
	shall be additional to the protective earth connection.

1.2.4Treatment location

The user must make sure that the location where the AK 98 dialysis machine is installed, including the patient environment, is suitable for dialysis treatment. The location shall be maintained at a hygienic standard suitable for dialysis treatment and kept free from pets and pests.

The dialysis treatment shall not be performed in proximity to high-powered ME EQUIPMENT.

Any other electrical equipment used in the patient environment shall be marked with:

Any other electrical equipment not having this mark shall be located outside the patient environment. A potential equalisation connection has to be used when it is legally required.

1.2.5Central venous catheter

If a central venous catheter is used during treatment with the tip of the catheter close to the heart a potential equalisation connection must be used.

1.2.6Connection of external electrical equipment

The AK 98 dialysis machine is equipped with three interface contacts on the back side; a 25 pole D-Sub, a USB and an Ethernet connector. These connectors shall only be used by an authorised service technician. All other use is prohibited.

1.2.7How to move the AK 98 dialysis machine

Always use the transportation handle when moving the dialysis machine. Take a firm hold on the transportation handle and gently pull the device over a step, do not push. Make sure the brakes are released before moving the dialysis machine.

WARNING!

If a remote Operator's Panel has been installed, fluid bags shall be removed from the infusion stand when transporting (moving) the machine to avoid overbalance. The fluid bags may be placed on the top tray.

CAUTION!

Do not move the dialysis machine during a treatment. If you need to move the dialysis machine to reach the side only do small adjustments and make sure not to overbalance or collide the dialysis machine as this could damage the equipment.

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CAUTION!

When moving the dialysis machine, take a firm hold on the transportation handle and gently move the device over obstacles. Do not move the machine with anything hanging from the infusion stand or with anything standing at the base plate of the machine as this may make the dialysis machine unstable.

1.2.8Safety philosophy

To maintain a safe treatment the AK 98 dialysis machine contains a control system and a protective system. Controllable treatment parameters (i.e. conductivity, temperature and ultrafiltration) are supervised by the control system.

The protective system triggers an alarm if a treatment value is outside its alarm limits. When an alarm is triggered, the protective system takes appropriate measures and puts the AK 98 dialysis machine into a patient-safe condition, for example by stopping the blood pump, closing the venous clamp or preventing the dialysis fluid from reaching the dialyzer.

The functionality of the protective system is checked by the AK 98 dialysis machine during functional check before each treatment. A fault detection during the pre-treatment tests will make it impossible to start the treatment.

Ultrafiltration

The ultrafiltration supervision feature uses an independent pair of flow sensors for the ultrafiltration protective system.

Venous pressure

The protective system checks the venous pressure to prevent patient blood loss.

WARNING!

Under certain circumstances the patient may suffer from blood loss, without the venous pressure passing any alarm limit. To avoid this, make sure that the blood circuit and the needle are correctly connected, tight and secure and that the low alarm limit is set as close as possible to the actual venous pressure.

Blood pump

The protective system checks how long time the blood pump is stopped during a treatment, to make sure the blood in the dialysis machine blood lines does not coagulate.

Blood leak detector

The protective system checks that the blood leak detector is able to detect the presence of blood in the dialysis fluid.

Air detector

Any air that enters the blood lines upstream of the air detector is trapped in the venous drip chamber. After a certain volume of air has been trapped an alarm is given.

1.3Intended use

1.3.1Intended use

The AK 98 dialysis machine is intended for use as a single patient machine to perform haemodialysis treatments of patients with renal failure or fluid overload upon prescription by a physician. Patient counselling and teaching of treatment techniques are directly under the supervision and discretion of the physician. The AK 98 dialysis

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machine is intended for the incenter environment and care in a home healthcare environment.

WARNING!

Treatment in a home healthcare environment shall only be allowed if the operator has received proper training to enable her / him to prepare the machine, perform and end the treatment in a safe way, and disinfect and clean the machine between treatments. Training shall be based on a profile assuming maximum of eight years of operator’s education. The physician is responsible to ensure that the competence of the operator is checked on regular basis. Records of the training and competence checks shall be archived by the responsible physician.

CAUTION!

Patient education, counselling, home care follow-up and medical maintenance must be performed under the direction and supervision of the physician prescribing the treatment. Baxter specifically denies any responsibility for patient education, counselling or home care and medical maintenance.

CAUTION!

When the AK 98 dialysis machine is used to produce bicarbonate containing dialysis fluid originating from non-liquid concentrates, the AK 98 dialysis machine is designed and validated for use with the BICART cartridge. Baxter does not accept responsibility for use of other non-liquid concentrate containers as the proper functionality cannot be guaranteed.

CAUTION!

The physician is responsible to ensure that the operator has access to the AK 98 operator’s manual when performing haemodialysis in a home healthcare environment.

CAUTION!

Additional measures to supervise the patient weight loss is recommended when treating low weight patients or when performing long treatments. For Ultrafiltration details, refer to Technical data and specifications.

NOTE!

The AK 98 dialysis machine is intended for continuous operation.

1.3.2Training

Everyone that works with the dialysis machine, its accessories or the patient, must go through proper training to learn about haemodialysis and how to handle the dialysis machine in a correct and safe way.

This operator's manual is the primary training material for anyone who is to operate the AK 98 dialysis system.

It is essential to read or being trained on the full content of the Operator’s manual before operating the AK 98 dialysis machine.

Training can be arranged after request from your local Baxter representative.

1.3.3Disinfection and functional check

Always perform a disinfection after installation, before initial use.

When the dialysis machine is new it needs to complete an extended functional check before you can connect the patient. See Section 4.2.2 “Start functional check” on page A:76

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1.3.4Inlet water requirements

The inlet water must meet a number of requirements regarding its quality. Normally this requires some technical equipment to purify the water.

Maintaining and disinfecting this equipment, including the distribution loop, regularly is essential.

The inlet water must comply with valid standards for water for dialysis; see Section 14.1.16 “Water supply” on page A:183.

Failure to meet the requirements of the inlet water may lead to hemolysis due to undesired substances in the water.

1.3.5Hygienic quality of central delivery systems

The user is responsible for the hygienic quality of any delivery systems, e.g. central water supply system, central delivery systems, haemodialysis equipment connecting devices, including the fluid lines from connection points to the haemodialysis equipment.

1.3.6Preparing dialysis fluid

The dialysis machine can prepare dialysis fluid from incoming water, acidic (A) concentrate and dry bicarbonate concentrate (BICART cartridge).

Dialysis fluid can also consist of incoming water, an acidic (A) concentrate and a liquid bicarbonate (B) concentrate. See Section 1.4.1 “Concentrates, chemical disinfectants, accessories and disposables” on page A:21.

1.4Accessories

1.4.1Concentrates, chemical disinfectants, accessories and disposables

Baxter does not accept responsibility if the dialysis machine is used with concentrates, chemical disinfectants, accessories, or disposables other than those specified in this section. Using other material may reduce Baxter’s warranties for the dialysis machine.

WARNING!

To ensure proper functionality of the AK 98 dialysis machine, use only concentrates, chemical disinfectants, accessories, and disposables specified as follows as these has been tested and validated for use with the AK 98 dialysis machine.

CAUTION!

Baxter does not accept any responsibility or liability for use of concentrates, chemical disinfectants, accessories, or disposables other than those specified as follows. Depending on the circumstances, use of concentrates, chemical disinfectants, accessories, or disposables other than those specified may also reduce Baxter’s warranties for the AK 98 dialysis machine.

CAUTION!

To ensure proper functionality of the dialysis machine, observe the manufacturer's instructions for use regarding blood lines and dialyzers for single use.

NOTE!

The user should make sure a current listing of concentrates, chemical disinfectants, accessories, and disposables is available.

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NOTE!

The user should follow the facility procedures for proper disposal of used blood lines, dialyzers and other disposables per local regulations.

1.4.2Concentrates

Accessories mentioned in this section are approved and required for use with the AK 98 dialysis machine.

CAUTION!

Incorrect choice of dialysis fluid concentrate may cause incorrect composition of the dialysis fluid. Incorrect composition may lead to electrolytic imbalance in the patient's blood.

Table 1-2. Liquid concentrates

	Liquid concentrates	Intended use
	SOFTPAC	The SOFTPAC product is an acid concentrate
	G- and C-series	for bicarbonate based hemodialysis and is
		intended to be used together with the BICART
		cartridge for on-line preparation of
		hemodialysis, hemodiafiltration or
		hemofiltration fluids on compatible Baxter
		dialysis machines.
		To obtain a current listing of recommended
		concentrates contact your local sales office.
	SOFTPAC Citrate	The SOFTPAC Citrate product is intended to
	G- and C-series	be used as a citrate based acid concentrate
		together with the BICART cartridge for on-line
		preparation of hemodialysis, hemodiafiltration
		and hemofiltration fluids on compatible Baxter
		dialysis machines.
		To obtain a current listing of recommended
		concentrates contact your local sales office.

Table 1-3. Non-liquid concentrates

Non-liquid concentrates	Intended use
BICART cartridge	Dry bicarbonate concentrate for preparation of
	bicarbonate dialysis fluid together with proper
	liquid A-concentrate.
	To obtain a current listing of recommended
	concentrates contact your local sales office.

1.4.3Chemical disinfectants

Accessories mentioned in this section are approved and required for use with the AK 98 dialysis machine.

Chemicals suitable for disinfection and concentrations thereof are listed in Section 14.1.10 “Disinfection and cleaning – chemical disinfection” on page A:180. Chemical disinfectants may be harmful to the materials used in the fluid path of dialysis machines. Therefore it is important to use the right disinfectant and be aware of the precautions for a certain chemical disinfectant before use, see Section 10.4.7 “About chemical disinfectants” on page A:152.

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1.4.4Blood lines

Accessories mentioned in this section are approved and required for use with the AK 98 dialysis machine.

CAUTION!

Do not use the neonatal blood lines: A-5.128-B4, V-5.127-X, A-5.129-B4 or V-5.129-X with AK 98 dialysis machine as these neonatal blood lines are not intended for use with the AK 98 dialysis machine.

Table 1-4. Blood lines

Line number	Area of use

The following blood lines manufactured by Gambro, are available for use on AK 98 dialysis machine:

		GMB S Series	Arterial and venous blood line set
		GMB Series	Arterial and venous blood line set
		CBL Series	Arterial and venous blood line set
		BL 10 series	Arterial and venous blood line set
		BL 95 SN	Arterial and venous blood line set
		BL 120N	Arterial and venous blood line set
		BL 100 Series	Arterial and venous blood line set
		BL 200 Series	Arterial and venous blood line set
		BL 200 S Series	Arterial and venous blood line set
		A 5000 and V 5000 Series	Arterial and venous blood lines
		The following blood lines manufactured by Vital,
		are available for use on AK 98 dialysis machine:
		BL 05	Arterial and venous blood line set
		BL 24	Arterial and venous blood line set
		BL 25	Arterial and venous blood line set
		BL 90	Arterial and venous blood line set
		BL 008	Arterial blood line set
		BL 009	Venous blood line set
		BL 10 R	Arterial and venous blood line set
		BL 10	Arterial and venous blood line set
		BL 90 D4	Arterial and venous blood line set
		BL 14	Arterial and venous blood line set
1.4.5	Accessories
	Table 1-5. Accessories
		Line number	Area of use
		C series	Haemodialysis accessories
		C 705	A connection line with an expansion chamber.
			Used in single needle mode.
		SP series	Haemodialysis accessories

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1.4.6Ultrafilter

Accessories mentioned in this section are approved and required for use with the AK 98 dialysis machine.

The dialysis machine has a holder for an ultrafilter. The purpose of the ultrafilter is to clean the dialysis fluid further from possible contamination by bacteria and endotoxins.

Table 1-6. Ultrafilter

Ultrafilter	Area of use
U9000	Ultrafilter used for preparation of ultra filtered
	dialysis fluid.

1.4.7Dialyzers

Accessories mentioned in this section are approved and required for use with the AK 98 dialysis machine.

NOTE!

The listed dialyzers have been determined by Baxter to meet the specifications and instructions for use given for the AK 98 dialysis machine with regards to e.g. the recommended priming procedure; in addition, the connectors and the ports of the dialyzers comply with ISO 8637 and EN 1283.

Table 1-7. Dialyzers

Dialyzer

POLYFLUX series

REVACLEAR series

EVODIAL series

THERANOVA series

Area of use

These hollow fiber dialyzers have been validated by Baxter for use with the AK 98 dialysis machine.

1.4.8Blood pressure measurement accessories

Accessories mentioned in this section are approved and required for use with the AK 98 dialysis machine.

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Table 1-8. Blood pressure measurement accessories

GAMBRO Cuff	Size
Adult	23 - 33 cm
Large Adult	31 - 40 cm
Small Adult	1725 cm
Child	12 - 19 cm
GAMBRO Cuff	Size
(single hand)
Adult	28 - 37 cm
Large Adult	36 - 46 cm
Small Adult	21 - 29 cm
GAMBRO Cuff hose
3.0 m	Cuff hose is used to connect cuff and AK 98
	dialysis machine.

1.5Glossary

1.5.1	Glossary
	Table 1-9. Defintions
		Authorised service technician	A service technician certified by Baxter.
		CIS	Clinical Information System
		Cleaning	Removing fats, proteins and organic material
			from the fluid path downstream of the dialyzer
			(post dialyzer). See Section 10.1 “Disinfection
			and cleaning – general” on page A:144.
		Decalcification	Removing calcium and magnesium-carbonate
			from the fluid path, originating from the
			bicarbonate dialysis fluid. See Section 10.1
			“Disinfection and cleaning – general” on
			page A:144.
		Disinfection	A process that destroys or removes
			microorganisms. See Section 10.1
			“Disinfection and cleaning – general” on
			page A:144.
		Dwell Time	The period that the fluid path is filled with
			disinfectant.
		Functional check	Before a treatment can be started the dialysis
			machine performs a functional check. The
			machine checks that internal functions are
			working. The machine performs either an
			extended functional check or a shorter basic
			functional check. See Section 4.2.2 “Start
			functional check” on page A:76.
			"Functional check" in this manual refers to
			either basic functional check or extended
			functional check. When a specific functional
			check is described "extended functional check"
			or "basic functional check" will be used.

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Operator	A person who has knowledge of, and has been
	trained in haemodialysis. The operator is in
	charge of the machine, which means that the
	operator makes the machine settings, which
	have to be done before, during, and after the
	haemodialysis treatment. It is important that
	the operator has access to the AK 98
	Operator’s manual when performing
	haemodialysis treatment. The operator is
	sometimes referred to as ”you”.
	When performing haemodialysis treatment in a
	home healthcare environment, the operator
	can also be the patient.
Patient environment	The patient environment is the volume
	surrounding the patient during treatment. The
	size of this patient environment must be
	determined from case to case by the user and
	the authorised service technician.
Patient ID	A patient unique alphanumeric code, used to
	identify the patient in the Clinical Information
	System.
Physician	A person prescribing the treatment of the
	patient.
User	A person who has the comprehensive
	responsibility for how the AK 98 dialysis
	machine is being used. The user decides
	which local routines are applicable for the
	AK 98 dialysis machine.

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2	Machine Description
	2.1	Blood part.................................................................................................................	A:28
	2.1.1	Blood part components.........................................................................................	A:28
	2.1.2 Blood part component details ...............................................................................		A:29
	2.2	Fluid part ..................................................................................................................	A:36
	2.2.1	Fluid part components ..........................................................................................	A:36
	2.2.2 Fluid part component details ................................................................................		A:37
	2.3	Rear component ......................................................................................................	A:44
	2.3.1	Rear components .................................................................................................	A:44
	2.3.2	Rear component details........................................................................................	A:45

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2.1Blood part

2.1.1Blood part components

Figure 2-1. Blood part component terms

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