AK 98 Operators Manual ver 2.xx Oct 2016

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 +46 46 169000 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

4

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

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

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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 8

Set and activate profiling with a preset model ... A:125

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

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9.7

Set an alarm for low K or Kt/V ... A:140

9.8

Factors that affect measuring ... A:140

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

1.1

Important while reading the operator’s manual

1.1.1

About 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.

1.1.2

Safety 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.

1.1.3

Values 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.

1.1.4

Buttons 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 Program version 2.xx

1.1.5

About 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.

HCEN12745 Revision 10.2016 Program version 2.xx

AK 98 Dialysis Machine - Before you get started

A:11

1.1.6

Symbols 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

A:12

AK 98 Dialysis Machine - Before you get started

HCEN12745 Revision 10.2016 Program version 2.xx

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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AK 98 Dialysis Machine - Before you get started

A:13

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.

A:14

AK 98 Dialysis Machine - Before you get started

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1.2

General warning and precautions before use

1.2.1

General 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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AK 98 Dialysis Machine - Before you get started

A:15

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.

A:16

AK 98 Dialysis Machine - Before you get started

HCEN12745 Revision 10.2016 Program version 2.xx

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.

1.2.2

Responsibility 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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AK 98 Dialysis Machine - Before you get started

A:17

1.2.3

Leakage current and potential equalisation connection Definitions

1.2.4

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.

Treatment 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.

1.2.5

Central 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.

1.2.6

Connection 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.

1.2.7

How 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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AK 98 Dialysis Machine - Before you get started

HCEN12745 Revision 10.2016 Program version 2.xx