Flow Cytometer

XF-1600
Instructions for Use

© SYSMEX CORPORATION

Code No. CD620558 en-eu
PRINTED IN JAPAN
Date of Issue or Revision: 03/2023
Document Version: 5.0
Software Version: 0 onwards

Revision history

Revision history
03/2022
Initial issue
Document version: 1.0
Software version: 0
04/2022
Document version: 2.0
Software version: 0
08/2022
Document version: 3.0
Software version: 0
02/2023
Document version: 4.0
Software version: 0
03/2023
Document version: 5.0
Software version: 0
Changes are listed below.
Revised section

Page

1.1 Intended purpose

10

2.3 Installation

16

5.2 Reagent list

33

7.1.1 Physical specifications

37

8.5 Main screen

55

8.5.2 Status area

57

8.6 List of access privileges for each user authority

59

9.7 Registering lot information

68, 69

9.9 Performing daily QC

76

9.10.4 Managing QC data

81

9.11 Managing QC files

83, 84

9.12 Backing up QC files

84

9.13 Restoring saved QC files

85

10.1.1 [Worklist] tab

89, 91

10.3 Registering subset panel analysis conditions while running a sample

97

10.10 Validating workitems

115

10.12 Saving validated workitems in FCS format

117

10.13 Outputting validated workitem data to the host computer

117,118

10.14 Backing up workitems

118, 119

10.15 Restoring a saved workitem (restore)

119

10.23 Backing up panels

126

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Revision history

Revised section

Page

11.6 Registering a panel QC file

135, 136, 138, 139, 140, 141,
142, 143

11.7 Performing daily panel QC

147, 148, 149

11.9 Managing panel QC files

158

11.10 Backing up panel QC files

159

13.4 [XF-1600 File] tab

179, 180

13.5.1 [Gate] group

181

13.5.4 [Edit] group

188

13.7.1 [Compensation] group

192

13.8.3 [Item] group

204

15.1 Settings by objective

230

15.2 Settings available for each user authority

230, 231

15.3.1 Opening the IPU settings dialog box

233

15.4.1 Manage settings

236

15.4.3 System language
15.4.6 User administration
15.4.7 Password management

238
240, 241, 242
243, 244

15.4.8 Account Lockout

244

15.5.1 Manage settings

250

15.5.2 Alarm sound

252

15.5.3 Instrument

252

17.9.7 Auto loader motor test

277

17.13 Barcode reader test

283

18.1 Error message list (in alphabetical order)

294

18.3 Causes of errors and remedial actions

303

Other changes:
- Clarifications to text

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Table of contents

Table of contents
Revision history

3

Chapter 1

9

1.1
1.2
1.3
1.4
1.5
1.6

Intended purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
About this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols used in this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols related to the products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trademarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 2
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10
2.11
2.12
2.13
2.14

15
15
16
17
17
18
18
18
19
20
21
21
22
26

27

Consumables, supply parts, and
options

31

Reagents

33

General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Reagent list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Chapter 6
6.1
6.2

15

Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Supply parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Chapter 5
5.1
5.2

Part names and functions

10
10
10
11
12
13

Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
IPU (Information Processing Unit) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Chapter 4
4.1
4.2
4.3

Safety information

Specified conditions of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Avoiding infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Handling of reagents and quality control materials. . . . . . . . . . . . . . . . . . . . . .
Laser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Disposal of materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Computer viruses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Use of other software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety labels on the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notice to the user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 3
3.1
3.2

Introduction

Installation

35

Preparing for installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

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Chapter 7
7.1
7.2
7.3

Basic operation

47

Overall operation workflow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Logging off from the IPU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Main screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
List of access privileges for each user authority . . . . . . . . . . . . . . . . . . . . . . . . 59

Chapter 9
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
9.9
9.10
9.11
9.12
9.13

37

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Supported sample tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Supported rotors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Chapter 8
8.1
8.2
8.3
8.4
8.5
8.6

Instrument specifications

Cytometer QC and setup

61

Overall cytometer QC workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Overview of cytometer QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Overview of baseline setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Overview of daily QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
QC files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
QC screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Registering lot information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Performing baseline setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Performing daily QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Checking daily QC results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Managing QC files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Backing up QC files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Restoring saved QC files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Chapter 10 Registering panel/subset panel and
workitems
87
10.1
10.2
10.3
10.4
10.5
10.6
10.7
10.8
10.9
10.10
10.11
10.12
10.13
10.14
10.15
10.16
10.17
10.18
10.19
10.20
10.21
10.22
10.23

Worklist area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Registering a panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Registering subset panel analysis conditions while running a sample. . . . . . . . 96
Registering a workitem in the worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Modifying workitems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Filtering workitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Sorting workitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Searching for workitems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Deleting workitems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Validating workitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Reloading workitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Saving validated workitems in FCS format . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Outputting validated workitem data to the host computer . . . . . . . . . . . . . . . . 117
Backing up workitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Restoring a saved workitem (restore) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Merging workitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Configuring acquisition conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Configuring compensation and creating plots . . . . . . . . . . . . . . . . . . . . . . . . . 121
Updating the subset panel master . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Modifying panel/subset panels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Copying panel/subset panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Deleting panel/subset panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Backing up panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

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10.24 Restoring a saved panel (restore) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Chapter 11 Panel QC
11.1
11.2
11.3
11.4
11.5
11.6
11.7
11.8
11.9
11.10
11.11

Overall panel QC workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview of panel QC (baseline setup and daily panel QC) . . . . . . . . . . . . .
Panel QC files. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Panel QC screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Registering a panel and corresponding subset panels. . . . . . . . . . . . . . . . . .
Registering a panel QC file. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Performing daily panel QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Checking daily panel QC results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Managing panel QC files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Backing up panel QC files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restoring saved QC files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 12 Running samples
12.1
12.2
12.3

175
176
177
177
180
189
191
201
205

207

229

Settings by objective. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Settings available for each user authority. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Opening the settings dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
IPU settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analyzer settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 16 Viewing logs
16.1
16.2

175

Creating a report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
The [Report] tab of the ribbon menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

Chapter 15 User settings
15.1
15.2
15.3
15.4
15.5

161

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Workarea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ribbon menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[XF-1600 File] tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[Home] tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[View] tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[Compensation] tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[Statistics] tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[Hierarchy] tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 14 Creating reports
14.1
14.2

129
130
131
131
134
135
144
151
158
158
159

Overview of measuring samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Setting measurement conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Running a sample. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Chapter 13 Data analysis tools
13.1
13.2
13.3
13.4
13.5
13.6
13.7
13.8
13.9

129

229
230
232
236
250

255

Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
History screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258

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Chapter 17 Maintenance
17.1
17.2
17.3
17.4
17.5
17.6
17.7
17.8
17.9
17.10
17.11
17.12
17.13
17.14
17.15
17.16

List of maintenance tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
Displaying the maintenance menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
Replacing the waste container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
Executing auto rinse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Replacing reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271
Removing air bubbles from the flowcell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Rinsing the flowcell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Testing instrument operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275
Replenishing the reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
Checking the cycle counter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279
Checking the instrument status (sensors) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
Barcode reader test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283
Replacing the air pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
Replacing a fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290
Maintenance and inspection checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292

Chapter 18 Troubleshooting
18.1
18.2
18.3

263

293

Error message list (in alphabetical order) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293
[Help] dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296
Causes of errors and remedial actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297

Index

309

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Chapter 1

Introduction

Chapter 1 Introduction
Thank you for purchasing the Sysmex Flow Cytometer XF-1600. Please read this manual carefully before
operating this product, and keep it in a safe place for future reference.

Note:
• Data generated by the XF-1600 is not intended to replace professional judgment in the determination of
a diagnosis or in monitoring patient therapy.
• Operate the instrument as instructed. Reliability of test results cannot be guaranteed if there are any
deviations from the instructions in this manual. If the instrument fails to function properly as a result of
either a user's operation not specified in this manual or a user's utilization of a program not specified by
Sysmex, the product warranty will be void.

In vitro diagnostic medical device

Contact Addresses
1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan
Authorized representatives
Europe, Middle East and Africa
Bornbarch 1, 22848 Norderstedt, Germany
Tel +49 40 5 27 26-0 / Fax +49 40 5 27 26-100

Americas
577 Aptakisic Road, Lincolnshire, IL 60069, U.S.A.
Tel +1-224-543-9500 / Fax +1-224-543-9505
Asia-Pacific
9 Tampines Grande #06-18 Singapore 528735
Tel +65-6221-3629 / Fax +65-6221-3687
Ordering of consumables/supply parts/options
If you need to order consumables, accessories, or options, please contact your
authorized local Sysmex representative.
Service and maintenance
Please contact your authorized local Sysmex representative.

The system described in this manual is marked with the CE mark, which
confirms compliance with the applicable requirements of:
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices
• Directive 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment and its related amending
directives including (EU) 2015/863 amending Annex II of Directive 2011/65/
EU

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1.1

Introduction

Intended purpose

The Sysmex Flow Cytometer XF-1600 is intended for use as an in vitro diagnostic device for immunophenotyping.
It is equipped with 10 fluorescence detection channels and two light scatter channels by means of a blue (488
nm) laser, a red (638 nm) laser, and a violet (405 nm) laser. It is to be used by healthcare professionals and
properly trained personnel in a laboratory environment. It is intended to be used to analyze human specimens
in conjunction with appropriate antibody reagents to generate information that will serve as an aid to diagnosis,
monitoring, or prognosis. The Sysmex Flow Cytometer XF-1600 works as an automated analyzer to provide
quantitative results. Manual review of the results and visual inspection of the plots is recommended.
For appropriate use of the product, refer to the instructions for use of the applicable reagents.

Caution
Diagnosis must be made using comprehensive judgment of all available information including but not
limited to immunophenotyping, pathological results, clinical symptoms, and patient history.

1.2

Overview of the system

The instrument consists of an analyzer and an Information Processing Unit (IPU).

1.3

About this manual

The following manual is provided with this instrument.
Type
Instructions for Use

Description
This manual explains how to operate the instrument.

Information
The English manual is provided with the instrument. For the translated most current version, please contact
your authorized local Sysmex representative.

1.3.1 Points to note about this manual
• You may not reproduce the contents of this manual in whole or in part without permission from Sysmex
Corporation.
• Images in this manual related to the product are for illustrative purposes only and may not exactly match the
product itself.
• While we have taken all possible precautions to ensure the quality of this manual, please contact your
authorized local Sysmex representative if you find any errors or omissions.

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1.4

Introduction

Symbols used in this manual
Risk of infection
Indicates a risk of pathogen infection that may ultimately lead to death if the user fails to observe the
indicated instructions.

Warning
Indicates a risk of death, serious injury, or serious property damage if the user fails to observe the indicated
instructions.

Caution
Indicates a risk of injury, incorrect output results, or property damage if the user fails to observe the
indicated instructions.

Caution, Hot
Indicates a risk of burns or other injury if the user fails to observe the indicated instructions.

Information
Indicates information for the purpose of maintaining instrument performance and preventing damage.

Note:
Indicates useful information for using the instrument.

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1.5

Introduction

Symbols related to the products
In vitro diagnostic medical device

Keep away from sunlight

Manufacturer

Use no hooks

Authorized Representative in
the European Community

This way up

Consult instructions for use

Keep dry

Temperature limitation

Stacking limit by number

Biological risks

Fragile, handle with care

Use by

Corrugated recycles

Batch code

Corrugated recycles*
* Based on SJ/T 11364 national
standard of China.

Catalogue number

Date of manufacture

Serial number

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1.6

Introduction

Trademarks

• Sysmex is a trademark of Sysmex Corporation, Japan.
• CyFlow is a trademark of Sysmex Corporation.
• ISBT 128 is a copyrighted system by and is used under a license agreement with International Council for
Commonality in Blood Banking Automation (ICCBBA).
• Windows is a trademark or registered trademark of Microsoft Corporation in the United States and other countries.
• Other company names and product names in this manual are trademarks of their respective owners.
The fact that a trademark is not explicitly indicated in this manual does not authorize its use. TM and ® are not
explicitly indicated in this manual.

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Introduction

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Chapter 2

Safety information

Chapter 2 Safety information
This chapter describes precautions for the safe use of this instrument.

2.1

Specified conditions of use

This instrument is a medical device used for in vitro diagnosis.
For the sheath fluid, cleaning agent, and quality control material, use the Sysmex-specified reagents indicated in this
manual. The use of other reagents may cause tube clogging and deterioration.
The conditions of use include cleaning and maintenance at the intervals specified in this manual.

2.2

General information
Warning
• Keep your hair, fingers and clothing away from the instrument when it is in operation.
You may be injured if caught in the instrument.
• Do not spill samples or reagents into the instrument, or get any metals, such as staples or clips, inside
the instrument.
Doing so could cause a short-circuit and smoke emission.
• Do not touch any electrical circuitry inside the cover.
The risk of electrical shock is especially high when your hands are wet.
• The instrument must not be connected to a power outlet other than that specified on the rating plate.
Please note that the instrument must be grounded.
Failure to do so may result in fire or electrical shock.
• Avoid damage to the power cable. Do not place any heavy object on the cable or pull on it.
Doing so may cause fire or shock due to an electrical short or break in the wiring.
• In the unlikely event that the instrument emits an unusual odor or smoke, immediately turn off the main
switch and unplug the power cable, then contact your authorized local Sysmex representative.
Continued use of the instrument in such conditions could result in fire, electrical shock or personal injury.

Caution
• When handling a sample tube containing a sample, take care that the sample does not spill.
• Do not lean against the instrument.
The resulting impact could damage the instrument or cause it to tip over.
• For cleaning and maintenance that requires a cleaning agent, always use CyFlow CLEAN. If CyFlow
CLEAN is not used, the instrument will not be cleaned sufficiently and problems may result.
• If a sample with large particles or high viscosity such as coagulated blood is acquired, correct results
may not be obtained, or a fluid line may clog and cause instrument failure.
The cTUVus mark indicates that the equipment has been tested and certified to comply with the
electrical and fire safety regulations of the US and Canadian governments.
Those tests were conducted thoroughly by TÜV Rheinland, which is accredited as a Nationally
Recognized Testing Laboratory (NRTL) by the Occupational Safety and Health Administration
(OSHA) of the United States, and by the Standards Council of Canada (SCC).

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2.3

Safety information

Installation
Warning
• Your authorized local Sysmex representative will unpack, install, and test the initial operation of the
instrument.
• This instrument must not be connected to a power outlet rated at anything other than that specified on
the rating plate. Please note that the instrument must be grounded.
Failure to do so may result in fire or electrical shock.
• Switch off the power supply before connecting any peripheral devices.
Failure to do so may result in electrical shock or damage to the instrument. In addition, an abnormal
stoppage may occur if a device is connected while the instrument is running.

Caution
• Install in a location where water will not splash or spray onto the instrument.
• Install in a location where the instrument will be protected from high temperature, humidity, dust and
direct sunlight.
• Do not install in a location subject to vibration.
• Do not subject the instrument to intense shock or vibration.
• Install the instrument in a well-ventilated area.
• Avoid installing the instrument near equipment that emits electrical interference, such as a radio or
centrifuge.
• Do not install the instrument near an area where chemicals are stored or gases are emitted.
• Do not use the instrument in a location where electroconductive gases, flammable gases, or anesthetics
that contain oxygen, hydrogen, or other flammable gases are present.
• Install the instrument indoors.
The instrument is intended for indoor use only.
• Place the reagent container at a level no more than 1 meter above or below the bottom of the analyzer.
Do not place reagents on top of the instrument.

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2.4

Safety information

Electromagnetic compatibility (EMC)

This instrument complies with the following IEC standards:
• IEC 61326-2-6:2005 (EN 61326-2-6:2006)
IEC 61326-2-6:2012 (EN 61326-2-6:2013)
Electrical equipment for measurement, control and laboratory use - EMC requirements
• EMI (Electromagnetic Interference). For this standard the requirements of class A are fulfilled.
• EMS (Electromagnetic Susceptibility). For this standard the minimum requirements with regards to susceptibility
are fulfilled.
• This equipment has been designed and tested to CISPR 11 Class A Group 1. This means that this product is not
intended to generate and/or use radio-frequency energy in the form of electromagnetic radiation, inductive, and/or
capacitive coupling during operation. This also means that the product is suitable for use in all facilities except for the
following:
• Domestic facilities
• Facilities directly connected to a low-voltage power supply network which supplies buildings used for domestic
purposes
In a domestic environment it may cause radio interference, in which case you may need to take measures to
mitigate the interference. The electromagnetic environment should be evaluated prior to operation of the device.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional
RF sources), as these may interfere with proper operation.

2.5

Avoiding infection
Risk of infection
• When performing any task with the instrument, such as analysis, maintenance, preparation, or post
processing, be sure to wear adequate personal protective equipment, such as protective gloves, a protective
mask, protective eyewear, and a lab coat. Wash your hands with antiseptic solution after completing the task.
There is a risk of infection.
• Be sure to connect the instrument’s drain tubing to a waste fluid tank at the facility or other dedicated
waste container.
If connecting the tubing to a waste fluid tank at the facility, use a tank with a connector to which the drain
tubing can be attached, or a tank with other means of securing the tubing in place so as to avoid the risk
of waste fluid spillage. In addition, exercise care so as to avoid such spillage, for example by regularly
verifying that the tube remains properly secured in place.
• Never touch waste, or parts that have come into contact with waste, with your bare hands.
If you inadvertently come into contact with potentially infectious materials or surfaces, immediately rinse
the skin with large amounts of water, and then follow your laboratory's prescribed cleaning and
decontamination procedures.
• Use appropriate care when handling samples and quality control materials.
In the event that an infectious material gets in the eyes or an open wound, rinse with large amounts of
water and seek immediate medical attention.
• Exercise caution when handling waste fluid. If waste fluid comes into contact with your body or clothes,
wash thoroughly.
• Do not dispose of waste fluid while acquisition is in progress.

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2.6

Safety information

Handling of reagents and quality control materials
Warning
• CyFlow SHEATH is an electrical conductor. If CyFlow SHEATH is spilled inadvertently near electrical
cables or appliances, there is a risk of electrical shock. Switch off the instrument, unplug the power cable,
and wipe off the CyFlow SHEATH.
• Do not clean the internal fluid lines of the instrument with a cleaning agent other than CyFlow CLEAN.
• CyFlow CLEAN is a strong alkali. Do not mix it with any acidic substances. Also, it should not come in
contact with skin or clothing. If contact occurs, rinse your skin or clothing with plenty of water to avoid
injury or damage.
• If CyFlow CLEAN comes into contact with the instrument's surface, it may corrode its finish. Immediately
wipe off with a damp cloth.

Caution
Follow the instructions on the reagent containers and boxes, package inserts, and safety data sheets.
For other cautionary points, see the following:
(➤P.33 "Chapter 5 Reagents")

2.7

Laser

Warning
The analyzer has a three-laser unit that is located inside the instrument. To avoid any risk of eye injury from
the laser, a protective cover is installed to prevent access by other than your authorized local Sysmex
representative.

2.8

Maintenance
Information
• When performing instrument inspection and maintenance, use the designated parts. Never use
substitute parts or perform modifications.
Doing so creates risk of instrument failure or damage.
• Use only the tools specifically authorized by Sysmex to perform maintenance.

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2.9

Safety information

Disposal of materials

2.9.1

Waste disposal

Risk of infection
After becoming waste at the end-of-life, this instrument and its accessories are regarded as infectious.
They are therefore exempted from Directive 2012/19/EU on Waste Electrical and Electronic Equipment and
may not be collected by public recycling authorities, to prevent possible risk of infection of personnel
working at those facilities.

Warning
• Do not dispose of the instrument, accessories, or consumables via public recycling.
• Incineration of contaminated parts is recommended.
• Please contact your authorized local Sysmex representative to receive further instructions for disposal.
Follow local legal requirements at all times.

Caution
Waste effluents from the instrument may contain dangerous substances, and any decisions regarding
disposal should be made only after consultation with local water authorities.

Waste end-of-life equipment should not be disposed of as unsorted municipal waste. It should be
collected separately.

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Safety information

2.9.2 Decontamination

Warning
Before decontaminating the instrument, be sure to turn off the power supply and unplug the power cord.
This is necessary to avoid the risk of electric shock. When cleaning the instrument, always wear adequate
personal protective equipment, such as protective gloves, a protective mask, protective eyewear, and a lab
coat. After decontamination, wash your hands carefully with antiseptic solution first and with soap
afterwards. Do not decontaminate the instrument's internal components. Internal decontamination should
only be executed by your authorized local Sysmex representative.

Information
• Decontamination of the instrument's outer surfaces should be performed in the following situations:
- Immediately after contamination with potentially infectious material
- In advance of repair or maintenance by your authorized local Sysmex representative
• Wear adequate personal protective equipment, such as protective gloves, a protective mask, protective
eyewear, and a lab coat.
• Wipe and clean contaminated surfaces with a common pH-neutral detergent solution until all visible
traces of contaminants, such as dried blood, are removed.
• Wipe the contaminated surfaces by using one of the following disinfectants* and allow adequate contact
time:
- Sodium hypochlorite (between 0.05 % and 0.5 %)
- 70 % ethanol or 70 % isopropyl alcohol
• Wipe the surfaces with a wet cloth dampened with distilled water to remove any remaining disinfectant
on the surfaces.
• Take care to prevent moisture from reaching the inside of the instrument.
• Take care to avoid applying any liquid close to or on the instrument’s touchscreen.
• As a final step, wipe the instrument with a dry disposable cloth.
*Make sure that you wet a cloth with the disinfectant before use. Do not apply the solutions directly to the
instrument surfaces. Doing so may cause damage to the surfaces or failure of the instrument. Although the
use of these solutions may cause some discoloration of the instrument coating, this does not affect the use,
safety, or performance of the instrument itself.

2.10

Operators
Caution
• The instrument must only be operated by properly trained personnel.
• If a malfunction of the instrument occurs, take only those measures specified in this manual. For further
assistance, please contact your authorized local Sysmex representative.

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2.11

Safety information

Computer viruses

Warning
Although our software has already been checked for computer viruses, the configuration of a specific user
environment may make it prone to computer virus infections via the Internet or a network.
We recommend that our customers consider computer virus countermeasures that suit their computer
operating environment. Customers that use antivirus software in their operating environment should take
the following precautions.
1. Use the antivirus software to periodically check for viruses.
(1) Use antivirus software designed for your operating system.
(2) Disable the antivirus software during instrument software operation, as it may adversely affect
instrument operation.
(3) Disable functions that check file access.
(4) Disable firewalls and any other functions that protect or control data transfers.
2. Do not install any software other than the antivirus software.
3. USB memory sticks, CD-Rs and other external memory devices should be checked for viruses before
use.
4. Do not open files attached to emails or files of unknown origin without first performing a virus check.
5. Do not download files from the Internet or other sources that are not required for instrument operation.
However, the virus definition files used by the antivirus software are not subject to this restriction.
6. Always check for viruses before accessing files in a folder shared with other computers.
7. Check the effectiveness of computer virus countermeasures used on other computer systems in your
laboratory, and select the most effective for use on this instrument.
8. The customer assumes sole responsibility when connecting to an external network (for example, the
Internet).

2.12

Use of other software

Warning
• Do not install any software other than that preinstalled on the instrument. Do not run any other software
on the instrument. However, this restriction does not include the installation of antivirus software.
• Note that Sysmex will accept no liability whatsoever for any malfunctions arising from use of other
software.

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2.13

Safety information

Safety labels on the instrument

Front and rear of analyzer

(2)
(4)

(3)

(1)

Front of analyzer

Rear of analyzer

(1) Auto loader

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.
(2) Sample tube holder

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.
(3) Periphery of AC power inlet

Warning
• Always unplug the power cable before servicing. There is a risk of electrical shock.
• Replace only with fuses of the specified type and current rating.
(4) Waste fluid outlet connector

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

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Safety information

Right interior

(1)
(2)

(1) Top of air pump unit

Caution, Hot
The surface of the air pump is hot. Do not touch. There is a risk of burn injury.
(2) Top of air pump unit

Warning
Always unplug the power cable before servicing. There is a risk of electrical shock.

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Safety information

Front (auto loader)

(1)

(1) Auto Loader (interior)

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

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Safety information

Front (sample tube holder)

(1)

(1) Sample tube holder (interior)

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

Waste container (optional)

(1)

(1) Waste container

Risk of infection
Treat all parts and surfaces of the instrument as posing a risk of infection.

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2.14

Safety information

Notice to the user

For a patient, user, or third party in the European Union, or in countries with an identical regulatory regime
(Regulation 2017/746/EU on In Vitro Diagnostic Medical Devices), if, during the use of this device or as a result of its
use, a serious incident occurs, please report it to the manufacturer or its authorized representative in the European
Union, and to your country's relevant authority.
Reports to the authorized representative in the European Union (Sysmex Europe SE) must be sent by email to:
vigilance@sysmex-europe.com, or by post to Sysmex Europe SE, Bornbarch 1, 22848 Norderstedt, Germany.

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Chapter 3

Part names and functions

Chapter 3 Part names and functions
This chapter provides an overview and description of the parts of the instrument.

3.1

Analyzer

Front view

(4)
(5)
(6)
(1)
(2)

(7)

(3)

(1) Auto loader analysis status indicator LED
Indicates the status of auto loader analysis.
Green light

Ready for analysis

Blinking green

Starting up/Analysis in progress/Maintenance in progress/Shutting down

Red light

An "analysis not possible" error has occurred (without alarm)/Stopped

Blinking red

An "analysis not possible" error has occurred (with alarm)

Not lit

Powered off/A different analysis mode is selected

(2) Auto loader analysis start switch
Press to start auto loader analysis.
(3) Auto loader
Open to load rotor for auto loader analysis mode.
(4) Manual analysis status indicator LED
Indicates the status of manual analysis.
Green light

Ready for analysis

Blinking green

Starting up/Analysis in progress/Maintenance in progress/Shutting down

Red light

An "analysis not possible" error has occurred (without alarm)/Stopped

Blinking red

An "analysis not possible" error has occurred (with alarm)

Not lit

Powered off/A different analysis mode is selected

(5) Manual analysis start switch
Press to start manual analysis.
(6) Mode switch
Press to switch between auto loader analysis mode and manual analysis mode.
(7) Sample tube holder
Open to load single sample tubes.

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Part names and functions

Right view

(1)

(2)

(1) Right cover
Opens to allow replacement of the air pump.
(2) Vent
Discharges heat from inside the instrument.

Right interior

(1)

(1) Air pump unit
Adjusts the air pressure that is supplied inside the instrument.

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Part names and functions

Rear view

(5)
(6)

(1)
(2)

(3)

(4)

(7)

(8)

(9)

(10)

(1) Main power switch
Turns the main power of the instrument ON/OFF.
(2) AC power inlet
Supplies power using the Sysmex-specified power cable.
(3) Fuse holder
Holds a 250 V, 10 A fuse (time lag).
(4) USB cable for IPU connection (USB 3.0)
Used for data acquisition. Connect to the USB 3.0 dedicated port on the IPU.

Caution
• This is a dedicated USB cable for use only with the IPU. Do not connect to a computer or any other device .
There is a risk of instrument malfunction and failure.
• Do not use a USB extension cable. There is a risk of lowered communication quality and instrument stoppage.
(5) SI-10 connection port
Connects to the SI-10 (optional).
(6) Port for an optional waste-container-full sensor
Connect the waste-container-full sensor to this port when the drain tubing is connected to the waste container.
For details, see the following:
(➤P.32 "4.3 Options")
(➤P.266 "17.3 Replacing the waste container")
(7) USB cables for IPU connection (USB 2.0)
Used for analyzer control. Connects to the USB 2.0 dedicated port on the IPU.

Caution
• This is a dedicated USB cable for use only with the IPU. Do not connect to a computer or any other device .
There is a risk of instrument malfunction and failure.
• Do not use a USB extension cable. There is a risk of lowered communication quality and instrument stoppage.
(8) Auxiliary port
This port is not used.

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Part names and functions

(9) Sheath reagent aspiration connector
CyFlow SHEATH is aspirated through this connector.
(10) Waste fluid outlet connector
Discharges waste fluid. Connect to a waste container or a waste fluid tank at the facility using the provided drain
tubing.

3.2

IPU (Information Processing Unit)

IPU
The operation of the IPU is based on Microsoft Windows. For information on how to use Microsoft Windows, see
the manual included with the operating system.

Caution
The IPU is a PC that is designed only for use with the instrument. It cannot be used as a general-purpose PC.

(1)

(2)

(4)

(3)

(1)
(2)
(3)
(4)

Monitor
Keyboard
Mouse
Main unit

Information
The above diagram is for reference only. Refer to the computer's manual for the location of connection ports and
other information.
For details, please contact your authorized local Sysmex representative.

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Chapter 4

Consumables, supply parts, and options

Chapter 4 Consumables, supply parts, and options
This chapter describes consumables, supply parts, and options.

Caution
Use only Sysmex-specified consumables, supply parts, and options.
If it is necessary to use consumables, supply parts, or options other than those described here, please contact
your authorized local Sysmex representative.

4.1

Consumables

The following consumables can be additionally purchased.
Product code

Item name

Sales unit

26677681

Fuse 50T100H

10

05104711

Air pump set No. 1

1

4.2

Supply parts

The following items are delivered with this instrument. Some items may not be available for additional purchase, or
the order unit quantity may differ from the quantity delivered with this instrument.
For details, please contact your authorized local Sysmex representative.
Product code

Item name

Quantity

CX036773

CDR_ASSY NO. 486

1

CQ710976

INTAKE TUBE_ASSY NO. 104 (reagent spout set)

1

CD620558

XF-1600 (IVD) IFU (EN-EU)

1

CV470813

MEDIA NO. 3 (device driver for barcode reader)

1

26677681

FUSE 50T100H

2

46231221

CAP OPENER NO. 2 (Used to open CyFlow SHEATH)

1

26652513

TIE WRAP PLT-1M

10

44253405

TUBE POLYURETHANE 6MMIDX9MMOD

1

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4.3

Consumables, supply parts, and options

Options

The following items can be ordered as optional items to be used with this instrument.
For details, please contact your authorized local Sysmex representative.
Item name

Description

Fixed rotor

24-position fixed rotor that can be loaded on the auto loader

Sysmex-Rotor 12 places

12-position swing-out rotor that can be loaded on the auto loader

Sysmex-Rotor 24 places

24-position swing-out rotor that can be loaded on the auto loader

Rotor barcode kit

Barcode labels for rotors

Waste container

Used with the waste container full sensor.

Waste container full sensor

Used with the waste container.

Graphic printer

Prints reports and lists of analysis information and results.

Handheld barcode reader

Reads barcodes on the outer box of CyFlow SHEATH, the assay sheet
of CyFlow DailyQC, or sample tubes.

External indicator light (SI-10)

Enables you to see the current instrument status, even from a
distance.

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Chapter 5

Reagents

Chapter 5 Reagents
This chapter describes the reagents that are used with the instrument.

5.1

General information

Before use, be sure to read the information on the reagent containers and boxes, reagent instructions, safety data
sheets, and this manual.
Always observe the cautions and instructions for each reagent.

5.2

Reagent list

The sheath fluid, cleaning agent, and quality control material used with this instrument are as follows.
Follow the instructions for use and safety measures provided for each reagent to ensure correct and proper use.
• Sheath fluid: CyFlow SHEATH
• Cleaning agent: CyFlow CLEAN
• Quality control material: CyFlow DailyQC

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Reagents

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Chapter 6

Installation

Chapter 6 Installation
This chapter provides information regarding installation of the instrument.

6.1

Preparing for installation

The instrument is installed or moved by your authorized local Sysmex representative. The following is a list of things
to do to prepare for the installation or move.
• Ensure that there is sufficient space for installation, with safety in mind.
For the required installation space, see the following:
(➤P.36 "6.2.4 Installation space")
• Note the weight of this instrument. Make sure that the floor and any equipment on which the instrument is to be
installed can withstand the weight.
• Once this instrument is delivered, check the condition of its packaging immediately.

Information
If the packaging has been damaged in any way, immediately contact your authorized local Sysmex
representative.
• Store the packaged instrument upright and in a dry place until it is time for installation.

6.2

Installation

6.2.1

Cautions on installation

The instrument and associated equipment are installed by your authorized local Sysmex representative. In case
relocation becomes necessary after installation, contact your authorized local Sysmex representative.
Problems resulting from moving of the instrument by anyone other than your authorized local Sysmex
representative are not covered by the warranty, even within the warranty period.

6.2.2

Grounding

The power cable of the instrument and any peripheral devices must be connected to a properly grounded power outlet.
An appropriate adaptor plug and Sysmex-specified power cables should be used according to your region.
For details, please contact your authorized local Sysmex representative.

Warning
• Be sure to ground this instrument. Improper grounding may cause electrical shock.
• Never exceed socket capacity. Failure to do so may cause a fire.

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Installation

Caution
Use the Sysmex-specified power cables. Do not use the Sysmex-specified power cables for any equipment
other than this instrument.

6.2.3 Installation environment
For the operating environment (ambient temperature, relative humidity, and air pressure), see the following:
(➤P.37 "Chapter 7: 7.1.1 Physical specifications")
For other conditions, see the following:
(➤P.16 "Chapter 2: 2.3 Installation")

Information
If the environment does not meet the ambient temperature and humidity requirements, control the
environment with air conditioning.

6.2.4 Installation space
Install the instrument with a clearance of at least 30 cm at the back and right side.
If the IPU will be installed on the right side of the instrument, take care not to block the vent.
Component
Analyzer

Width (mm)
Approx. 700

Depth (mm)

Height (mm)

Approx. 630

Approx. 740

Weight (kg)
Approx. 97

Approx. 890 (with the
auto loader ejected)
Approx.
700

Approx.
740

Approx.
630
Approx.
260

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Instrument specifications

Chapter 7 Instrument specifications
This chapter describes specifications, principles, and other technical information.

7.1

Specifications

7.1.1

Physical specifications
Item

Specification

Dimensions and weight

700 (W) x 630 (D) x 740 (H) mm, 97 kg
The dimensions (width, depth, height) and weight have an acceptable range of ±5
% for dimensions and ±10 % for weight, respectively.

Electrical ratings

Voltage:
Frequency:
Power consumption:
Protection type:

AC 100 V to 240 V
50/60 Hz
350 VA or less
Class I

Operating environment

Ambient temperature:
Relative humidity:
Air pressure:
Pollution degree:

18 °C to 28 °C
20 % to 85 %
80 kPa to 106 kPa
2

Noise level

60 dB or less
(75 dB or less for rinse cup discharge and alarm sounds)

Storage conditions

Ambient temperature:
Relative humidity:
Air pressure:

Laser

Class I (IEC 60825-1:2007, IEC 60825-1:2014)

Safety standards

IEC 61010-1:2010+A1, IEC 61010-2-081:2019, IEC 61010-2-101:2018

-10 °C to 60 °C
10 % to 95 % (no condensation)
70 kPa to 106 kPa

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7.1.2 Performance
Item

Specification

Acquisition rate

50,000 events/second

Minimum detectable particle size

FSC: 0.5 μm, SSC: 0.5 μm

Fluorescence sensitivity

FITC < 100 MESF
PE < 50 MESF
APC < 100 MESF

Fluorescence linearity

FL1 R2 ≥0.97
FL2 R2 ≥0.97
FL6 R2 ≥0.97

Repeatability*

Intermediate

precision**

FSC and SSC sensitivity

CV (%) ≤10 %

Fluorescence sensitivity

CV (%) ≤10 %

WBC events

CV (%) ≤10 %

FSC and SSC sensitivity

CV (%) ≤10 %

Fluorescence sensitivity

CV (%) ≤10 %

WBC events
Carryover

CV (%) ≤10 %
<0.1 %

* Refers to the coefficient of variation when the measurement is repeated at least 10 times, using the following
samples and the measurement conditions (panels).
- For FSC/SSC and fluorescence sensitivity: CyFlow DailyQC by applying the panel [QC panel]
- For WBC events: Commercially available stabilized blood materials prepared at WBC 300-600/μL which are
qualified for use on the XF-1600, by applying the panel [WRP_R panel]
** Refers to the coefficient of variation when the measurement is repeated for 20 days by conducting 2 runs with
2 replicates each day in accordance with CLSI EP05-A3.
- For FSC/SSC and fluorescence sensitivity: CyFlow DailyQC by applying the panel [QC panel]
- For WBC events: Commercially available stabilized blood materials prepared at WBC 300-600/μL which are
qualified for use on the XF-1600, by applying the panel [WRP_R panel]

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7.1.3

Instrument specifications

Optics

The semiconductor laser light (488 nm, 638 nm, and 405 nm) interrogates the cells and particles passing
through the flow cell. The forward scattered light is detected by a photodiode, and the side-scattered light and
fluorescence are detected by a photomultiplier. The light signals received by each detector are converted into
electrical signals, and by analyzing these signals, cell and particle information can be obtained.
Laser Diode (638 nm)

Laser Diode (405 nm)

Forward Scatter (FSC)

Flow cell

FL9

Laser Diode (488 nm)

FL6

FL10

FL7

FL8

Side Scatter (SSC)

FL5
FL2

FL4

Channel
FSC

Laser wavelength
488 nm

FL1

FL3

Fluorochromes or FSC/SSC

Optical filters

Forward scatter

-

SSC

Side scatter

-

FL1

FITC

530/30

FL2

PE

580/30

FL3

PE-DyLight 594

610/14

FL4

PerCP-Cy5.5

700/50

FL5

PE-Cy7

750LP

APC

660/20

FL7

Alexa Fluor 700

720/40

FL8

APC-Cy7

780/60

Pacific Blue

450/50

Pacific Orange

540/80

FL6

FL9
FL10

638 nm

405 nm

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Instrument specifications

7.1.4 Fluidics
Item
Flow rates

Specification
Low:
Middle:
High:

5 µL/min
30 μL/min or 60 μL/min
90 μL/min or 120 μL/min

7.1.5 Software specifications
Data storage capacity and output format.
Item

Specification

QC files

40 files for cytometer QC
(500 data points for each QC item)
50 files for panel QC
(200 QC items per file, 200 data points for each QC item)

Data output format

Flow Cytometry Standard (FCS) 3.0

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7.2

Instrument specifications

Supported sample tubes

⏺ Regular sample tubes
Item

Specification

Diameter (a)

12 mm ± 0.2 mm or 13 mm ± 0.2 mm

Length (b)

75 mm ± 5 mm

b

a

⏺ Micro collection tubes
Standard micro collection tube shapes are shown below.
Compatible dimensions vary depending on the shape of the micro collection tube. The following are only
guidelines. It will be necessary to check using the actual micro collection tube used.
Type B

Diameter 7.4 mm to 7.8 mm

8.5 mm

20 mm

Diameter 8 mm or less

Diameter 9.8 mm to 10.8 mm

36 mm to 46 mm

Diameter 13 mm or less

35 mm or more

Diameter 13 mm or less

27 mm or more

36 mm to 50 mm

35 mm or more

20 mm

Diameter 13 mm or less

Type C

28 mm to 48 mm

Type A

Diameter 10.0 mm to 11.0 mm

The cap is not included in the dimensions. Open the cap during analysis.

Note:
For information on using sample tubes not described here, please contact your authorized local Sysmex
representative.

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Instrument specifications

7.2.1 Acceptable barcodes for sample tubes
The types of barcodes that can be used and check digit support are listed below.

Caution
Use a check digit whenever possible when reading barcodes on sample tubes. There is a risk of incorrect
reading of the barcode if a check digit is not used.

Barcode types
ITF

Check digits

Number of digits

None

Max. 22 digits (sample No.)

Modulus 10

Max. 21 digits (sample No.) + 1 digit (check digit) = Max. 22 digits

None

Max. 22 digits (sample No.)

Modulus 11

Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits

Weighted
modulus 11

Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits

Modulus 16

Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits

None

Max. 22 digits (sample No.)

Modulus 43

Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits

JAN/EAN/UPC

Modulus 10

12 digits (sample No.) + 1 digit (check digit) = 13 digits

ISBT128

Modulus 103

Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits

CODE128

Modulus 103

Max. 22 digits (sample No.) + 1 digit (check digit) = Max. 23 digits

CODABAR/NW7

CODE39

Information
When using CODE128, do not use the following codes.
Code

CODE A

CODE B

Code

CODE A

CODE B

95

US

DEL

101

FNC 4

CODE A

96

FNC 3

FNC 3

102

FNC 1

FNC 1

97

FNC 2

FNC 2

103

START (CODE A)

98

SHIFT

SHIFT

104

START (CODE B)

99

CODE C

CODE C

105

START (CODE C)

100

CODE B

FNC 4

Note:
In CODE128, any one of the characters "A", "B", "C", "a", "b" or "c" can be used for the start/stop code.

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Instrument specifications

Barcode element dimensions
Narrow element ≥ 190 μm
Wide element ≤ 1.2 mm
Narrow element ≤ Gap between characters ≤ Wide element

Narrow/Wide ratio
Internal requirements pertaining to a single character are as follows:
Narrow (MAX):
Wide (MIN)
= 1:2.2 or more
Narrow (MIN):
Narrow (MAX)
= 1:1.3 or less
Wide (MIN):
Wide (MAX)
= 1:1.4 or less

PCS value (Print Contrast Signal)
PCS =

Reflectance of white - Reflectance of black
Reflectance of white

The measurement method is compliant with JIS × 0501 5.3 Optical Characteristics of Barcode Symbols
Specification: PCS value ≥ 0.45

Barcode label print quality
Use barcode labels of Label Grade "C" or higher as defined in the ANSI standards.
Laminated labels may not be readable.

Uneven printing
MAX
MIN

Bar

One bar of a barcode appears as shown on the left
when viewed under a microscope.
Expressing the irregularity in the width of one bar as
shown below, it is necessary that S ≤ 20 %.
S=

MAX - MIN
MAX

× 100 %

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7.3

Instrument specifications

Supported rotors
⏺ Fixed rotor
Accommodates up to 24 uncapped tubes

⏺ Swing-out rotors
• Accommodates up to 12 uncapped tubes

• Accommodates up to 24 uncapped tubes

Information
The XF-1600 can be used with the Sample Preparation System PS-10, which automates the process of
cell preparation for transfer to a flow cytometer, using the above rotors.
For appropriate use of the product, refer to the instructions for use of the PS-10.
To connect the XF-1600 to the PS-10, see the following:
(➤P.249 "Chapter 15: 15.4.15 PS-10")
For more details, please contact your authorized local Sysmex representative.

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7.3.1

Instrument specifications

Barcode labels for rotors

Information
Make sure that you use the barcode label included with the rotor.

⏺ Meaning of numbers on barcode labels

(1) (2)

(1) Rotor type
The rotor type is indicated by prefix numbers from 01 to 03. Ensure that the barcode label prefix
matches the type of rotor used.
03: Fixed rotors (24)
02: Swing-out rotors (24)
01: Swing-out rotors (12)
(2) Unique ID
Each rotor type has a barcode label bearing a number from 00 to 14.

⏺ Location of barcode labels
Apply the labels on the place indicated below for each rotor type so that they can be properly scanned by the
instrument.
Fixed rotor (24)

Swing-out rotor (12)

Swing-out rotor (24)

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Chapter 8

Basic operation

Chapter 8 Basic operation
8.1

Overall operation workflow

The chart below shows the operation sequence of the instrument. The typical workflow is shown in gray.

➤P.48

Startup

Self-test (approx. 10 minutes)

Chapter 9

➤P.61

Perform QC

Chapter 10 Register panel/subset panel and work
item
➤P.87

Chapter 11 Panel QC

➤P.129

Chapter 12 Run samples

➤P.161

Chapter 13 Analyze data

➤P.175

➤P.207

Chapter 14 Create reports

Has analysis ended
for the day?

No

Yes

• Log off/on as a different user
➤P.54

Have you
used the instrument
continuously for 24 hours
or more?

No

Yes

Shutdown

➤P.51

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8.2

Basic operation

Startup

8.2.1 Inspection prior to turning the power on
⏺ Instrument inspection
•
•
•
•

Check the tube and cable connections.
Check if there are any kinked tubes.
Check if there are any objects on the instrument.
If connected to a network, make sure that the network devices (hubs and network converters) are all powered
on.
• Discard any waste fluid in the waste container.
For the procedure for discarding waste fluid, see the following:
(➤P.266 "Chapter 17: 17.3 Replacing the waste container")

⏺ Reagent inspection
Make sure that there are sufficient amounts of reagents for the number of samples to be processed that day.
If a reagent runs out during acquisition, the instrument will automatically stop. Replace the reagent. Acquisition
cannot be resumed until the reagent is replaced.
The following table describes the amount of reagents required for startup, shutdown, and cleaning.
Note that the following values are for reference only. Depending on the circumstances of use, the values may
vary.
Instrument operation

CyFlow SHEATH

CyFlow CLEAN

Startup
(including 1 background check)

Approx. 160 mL

-

Shutdown

Approx. 80 mL

Approx. 2.5 mL

Cleaning
(➤P.271 "17.6 Cleaning")

Approx. 170 mL

Approx. 2.5 mL

Information
The reagent volumes required for running samples depend on the measurement conditions.

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8.2.2

Basic operation

Turning the power on

1 Verify that the main power switch of each device is on.
The analyzer power is controlled by the IPU, so the main power switch can be kept in the "ON" position at all
times. Check the main power of the following devices:
• Analyzer (➤P.27 "Chapter 3: 3.1 Analyzer")
• Monitor
• Printer (optional)

2 Turn the IPU power on.
The instrument power turns on and the analyzer runs a self-test. (➤P.50 "8.2.3
test")

Executing an analyzer self-

Note:
If an error occurs during startup (for example, [Tube remains in tube holder]), you must log on to the IPU to
clear the error.
The [IPU Logon] dialog box appears.

[IPU Logon] dialog box

3 Enter the [Logon Name] and [Password].
A dialog box prompting you to change your password appears when you log on for the first time. Please follow
the instructions to change your password.

Information
The software is installed with a default logon name [admin] with the password "admin".
The [admin] should be the first user to log in to the software and set up additional user accounts. For
details, see the following:
(➤P.239 "Chapter 15: 15.4.6 User administration")

4 Click [OK].
The main screen appears in the environment of the logged-on user.
For information about the main screen, see the following:
(➤P.55 "8.5 Main screen")

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Information
Do not restart or log off from Windows while the main power of the connected devices is ON. The devices
and IPU may fail to reconnect. If you restarted or logged off from Windows, shut down Windows, turn off
the main power of each device, and then repeat the procedure from step 1.

8.2.3 Executing an analyzer self-test
When the instrument power turns on, a self-test is automatically executed to check if there are any problems
with the analyzer. The self-test takes about 10 minutes. The self-test consists of the following tasks:

⏺ Initializing mechanical parts
The mechanical parts move to their initial positions, and the hydraulic parts are initialized and checked.

⏺ Rinsing hydraulic parts
Rinsing is performed 1 to 2 times, depending on how much time has elapsed since the previous rinsing.

⏺ Background check
A background check is performed without sample aspiration to check the effectiveness of rinsing. This is
repeated up to 3 times.
It is performed using measurement conditions for the background check. If the result (event count) does not
drop below the allowable value* after 3 runs, a [Background check error] occurs. For details, see the following:
(➤P.293 "Chapter 18 Troubleshooting")
* The factory setting for the allowable count value is 1,000.

Caution
Even if the results are not below the allowable value, you can end the check by clicking [Close] in the [Help]
dialog box. However, there is a risk that correct results may not be obtained.
Note that clicking [Close] does not clear the error.

Note:
To cancel logon and exit the IPU program, click [Abort]. You cannot exit the IPU program when the
instrument is in operation.

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