SP-1000i Instructions for Use sw ver 00-07 Oct 2004

Table of Contents

Table of Contents 1.

Introduction... 1-1

1.1 1.2

Danger information in this manual... 1-3 Trademarks... 1-4

2.

Safety information ... 2-1

2.1 2.2 2.3 2.4 2.5 2.6 2.7

Specified conditions of use... 2-1 General information ... 2-1 Installation ... 2-2 To avoid infection ... 2-3 Handling of reagents ... 2-4 Maintenance... 2-5 When discarding the waste, disposables and instrument ... 2-5 2.8 Markings on the instrument ... 2-7 2.9 Personnels... 2-11 2.10 Connecting to the host computer ... 2-11

Names and functions of components ... 3-1

3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9

Entire System ... 3-1 Main Unit ... 3-2 Pneumatic Unit ... 3-10 Sampler Unit (optional)... 3-12 Overview of the Display Screen ... 3-13 Menu Screen ... 3-14 Numerical keypad dialog ... 3-15 Status Display... 3-18 Menu Tree... 3-20

4.

Reagents... 4-1

4.1 4.2 4.3 4.4 4.5 4.6 4.7

CELLPACK ... 4-1 CELLCLEAN ... 4-1 May-Grünwald stain ... 4-2 Wright's stain ... 4-2 Giemsa stain ... 4-3 Phosphate buffer ... 4-3 Symbols used on the labels ... 4-4

5.

Sample registration ... 5-1

5.1 5.2 5.3 5.4

Sample registration screen... 5-1 New Registration ... 5-2 HC inquiry... 5-4 Deleting ... 5-5

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3.

Sysmex SP-1000i Instructions for Use

I

Table of Contents

6.

Making a smear... 6-1

6.1 6.2 6.3 6.4 6.5

Start-up procedure ... 6-1 Making smears using the optional sampler unit ... 6-8 Making smears manually ... 6-13 Executing shutdown... 6-17 Timer mode ... 6-18

7.

Smear List ... 7-1

7.1 7.2 7.3 7.4 7.5

Smear List Screen ... 7-1 Displaying selected data... 7-4 Search ... 7-5 Output... 7-6 Deleting ... 7-7

8.

Instrument Settings... 8-1

8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8

Entering the password ... 8-1 System settings ... 8-1 Device Settings... 8-6 Smear and Stain Settings... 8-17 Interface... 8-23 Sampler Settings ... 8-27 Backup... 8-29 Default Settings List... 8-31

9.

Cleaning and Maintenance ... 9-1

9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8

Daily maintenance ... 9-1 Weekly maintenance ... 9-10 Monthly Maintenance ... 9-14 As-needed Maintenance... 9-14 Supplies Replacements... 9-21 Viewing the service log... 9-30 Supplies list ... 9-32 SP-1000i Maintenance Check List ... 9-33

10. Troubleshooting... 10-1 10.1 10.2 10.3 10.4 10.5 10.6 10.7

Error dialog ... 10-1 Error list display screen ... 10-2 Action message ... 10-2 Error History ... 10-3 Error message list... 10-4 Troubleshooting Guide... 10-11 Test operation ... 10-43

11. Technical Information... 11-1

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11.1 SP-1000i Performance specifications... 11-1 11.2 Program version ... 11-1 11.3 Interface protocol ... 11-2

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Sysmex SP-1000i Instructions for Use

Table of Contents

12. Installation... 12-1 12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8 12.9

Unpacking Check List... 12-1 Check Before Installation... 12-5 Grounding... 12-5 Installation Environment ... 12-5 Removing the Shipping Fixtures... 12-6 Connect Pneumatic and Reagent Tubes ... 12-7 Connect Cords and Cables ... 12-10 Turn Power ON ... 12-11 Set IP Address ... 12-11

13. ID Bar Code Specifications... 13-1 13.1 ID Bar Code Specifications ... 13-1 13.2 Print Format by the thermal slide printer ... 13-5

14. SNCS (optional) ... 14-1 14.1 14.2 14.3 14.4 14.5

Introduction... 14-1 SNCS functions ... 14-2 Network Connection for online support ... 14-3 Manual Transmission of Data ... 14-4 Service Call ... 14-4

15. Warranty ... 15-1 16. GNU General Public License ... 16-1

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17. Index ... 17-1

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Table of Contents

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(Blank Page)

IV

Sysmex SP-1000i Instructions for Use

Introduction

1. Introduction The SP-1000i is a fully automated slide preparation unit for a hematology system. It performs all tasks involved in the preparation of smears, from sample aspiration to staining operation. By way of ID scanning, mixing and using the wedge method, the SP-1000i can make a smear from a sample that has been judged abnormal in an analysis using a hematology analyzer connected to a sample conveyor system such as the HST, Alpha and so forth. In order to make smears that are uniform and suitable for microscopy, staining solution is dispensed to each smeared slide one at a time. The SP-1000i receives the necessary information from the host computer or the conveyor system and makes smears according to the smearing conditions set up on the SP-1000i Main Unit.

Contact Address Manufacturer SYSMEX CORPORATION 1-5-1 Wakinohama-Kaigandori Chuo-ku, Kobe 651-0073 JAPAN Authorized Representative

EC

REP

European Representative SYSMEX EUROPE GmbH Bornbarch 1 D – 22848 Norderstedt, Germany Tel.: +49 40 5 27 26-0 Fax: +49 40 5 27 26-100

USA SYSMEX AMERICA, INC. 1 Nelson C. White Parkway, Mundelein, IL 60060, U.S.A. Phone: +1-847-996-4500 Fax: +1-847-996-4505

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Asia-Pacific SYSMEX SINGAPORE PTE LTD. 2 Woodlands Sector 1, #01-06 Woodlands Spectrum, Singapore 738068 Phone: +65-6-221-3629 Fax: +65-6-221-3687

Sysmex SP-1000i Instructions for use

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Introduction Ordering of Supplies and Replacement Parts For supplies or replacement parts, please contact your dealer or local Sysmex representative.

Service and Maintenance Please contact your dealer or local Sysmex representative.

Training courses Please contact your dealer or local Sysmex representative for details. Options

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The following devices are available as optional equipment. Sampler: Feeds the samples to the main unit automatically. Handy ID Bar Code Reader: Scans the bar coded sample ID number for automatic entry in the instrument when making smears manually. Waste level monitoring sensor: Alerts the operator that the waste container gets full.

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Sysmex SP-1000i Instructions for use

Introduction

1.1 Danger information in this manual

Risk of infection Indicates the presence of a biohazardous material or condition.

Warning! If this sign is ignoring and the instrument is operated incorrectly, a potentially hazardous situation could result in death or serious injury of an operator, or grave property damage.

Caution! If this sign is ignored and the instrument is operated incorrectly, there is a potentially hazardous situation which may result in injury of an operator, adverse effect on the analysis results, or may cause property damage. To avoid property damage and incorrect measuring results of the smear.

Important! Indicates what you need to know in order to maintain instrument performance and prevent damage.

Note:

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Indicates information which will be useful in operating the instrument.

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Introduction

1.2 Trademarks • • • •

Sysmex is a registered trademark of Sysmex Corporation. CELLPACK and CELLCLEAN are trademarks of Sysmex Corporation. Linux is a registered trademark or trademark of Linus Torvalds in U.S.A. and other countries. SARSTEDT, S-MONOVETTE and MICROVETTE are registered trademarks of Walter Sarstedt Geräte und Verbrauchsmaterial für Medizin und Wissenschaft.

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All other trademarks not explicitly mentioned in this manual belong to their respective owners. Sysmex does not authorize its use.

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Sysmex SP-1000i Instructions for use

Safety Information

2. Safety Information 2.1 Specified conditions for use The SP-1000i is designed for making smears of human peripheral blood. The instrument is not intended for any other use. The specified conditions for use also include performance of the periodical cleaning and maintenances.

2.2 General information Before using the SP-1000i, please read this manual carefully so that you can use the instrument correctly. After reading the manual, keep it handy so that you can always refer to it.

Warning!

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• Unpacking, installation and confirmation of initial setup are carried out by your dealer or a local Sysmex representative. • Keep long hair, fingers and clothing away from moving parts while operating. • Should the instrument emit unusual odors or smoke, turn the main switch OFF immediately and unplug the power cable. Contact your Sysmex service representative for an inspection. Using the instrument any further bears the risk of fire, electric shock or personnel injury. • Do not spill the liquids such as blood samples or reagent on the unit. Do not put metal objects such as staples or paper clips on the instrument. This could cause a shortcircuit or fumes. Should the instrument emit unusual odors or smoke, turn the main switch OFF immediately and unplug the power cable. Contact your Sysmex service representative for an inspection. • Do not touch the electric circuit inside the instrument cover. There is a risk of an electric shock, especially with wet hands. • Never insert the power plug into power socket other than the specified voltage. Please note that the instrument must be grounded (earthed). Ignoring this may result in a fire or an electric shock. • Avoid damage to the power cable. Do not place any appliances on the power cable. Do not pull on the power cord. Failure to observe this instruction may cause shortcircuit or a disconnection that could lead to a fire or an electric shock.

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Safety Information .

Warning! • Turn the power supply OFF before connecting peripheral devices (such as host computer or handheld bar code reader). Failure to observe this instruction may cause an electric shock or a permanent damage to the peripheral devices.

2.3 Installation

Caution! • Instrument must be protected against splashing water. • The instrument must be installed in a dry and dust-free location. Install in places where there are no adverse effects from high humidity and dust. Do not expose the instrument to excessive temperature fluctuation and direct sunlight. • Avoid shock and vibrations. • The installation location must be well ventilated. • Avoid installation near devices causing potential interference, such as radios, centrifuges, personal computer monitors, wireless communication equipment or similar devices. • Installation of this instrument in places where chemicals are stored or hazardous gas may be present is not permitted. • Do not operate the instrument in an atmosphere containing conductive gases, inflammable gases or narcotics containing oxygen, hydrogen or other inflammable gases. • The instrument is designed for indoor use. • Plug the power cable into an outlet where you can reach with your hand.

2.3.1 Installation Space Secure a place spacious enough for maintenance and service. Giving consideration to heat radiation by the instrument, provide at least 50 cm distance from the wall to side, rear and top panel. Width (mm)

Depth (mm)

Main Unit

865

860

660

Sampler

510

220

110 (255*) Approx. 7.2

Pneumatic unit

280

355

400

Height (mm)

Weight (kg) Approx. 100 Approx. 17

*: Indicates the height including the tube detection sensor.

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Sysmex SP-1000i Instructions for use

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Component

Safety Information

220

720

660

110 865

2.4 To avoid infection

Risk of infection

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• In principle, all parts and surfaces of this instrument must be regarded as potentially infectious, since this instrument analyzes patient specimens. • Never touch waste, or parts having been in contact with waste, with your bare hands. • Should you inadvertently come in contact with potentially infectious materials or surfaces, immediately rinse skin thoroughly with water, and follow your hospital or laboratory's prescribed cleaning and decontamination procedures. • Wear protective garments and gloves when handling patient samples. Use protective garments and gloves when operating, maintaining, or servicing the unit is strongly recommended. If a sample gets in contact with your eye or wound, wash it with water and see a physician. • Use protective garments and gloves when handling waste. If they come into contact with your skin or clothing, wash it off with disinfectant.

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Safety Information

2.5 Handling of reagents

Warning! • Avoid direct contact with reagents. Reagents can cause irritation of the eyes, skin and mucous membranes. • Should you inadvertently come in contact with a reagent, rinse skin immediately with plenty of water. • At eye contact, rinse at once with plenty of water. See a physician immediately. Observe the material safety data sheet (MSDS). • If reagent was swallowed, obtain immediate medical advice. Observe the material safety data sheet (MSDS). • The CELLPACK diluent is conductive. If the CELLPACK diluent is spilt inadvertently near electrical cables or appliances, there is a risk of electric shock. Switch the instrument power OFF, unplug and remove the liquid. • CELLCLEAN is a strong alkaline cleaning material. It should not come in contact with skin or clothing. If it happens nevertheless, rinse skin or clothing with plenty of water to avoid injury or damage, respectively. • CELLCLEAN cleaning material contains sodium hypochlorite. If CELLCLEAN makes contact with the instrument's surfaces, it will affect the surface finish and there is danger of corrosion. Immediately wipe up CELLCLEAN with a damp cloth. • Methanol and the staining solution containing methnol are frammable in an environmental temperature. Handle with care.

Caution!

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• Observe the markings on the reagent's packages as well as the information on the package inserts. • Avoid contact dust, dirt or bacteria with the reagent especially when installing new reagents. • Reagents must not be used after their expiration date. • Handle reagents gently to avoid bubbling. Do not shake! Do not use reagents directly after transportation. • Do not spill reagents. If reagent is spilt, wipe up with a damp cloth.

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Sysmex SP-1000i Instructions for use

Safety Information

2.6 Maintenance

Risk of infection • Always wear protective garments and gloves when servicing and maintaining. After completion of work, wash hands with disinfectant. • Use protective garments and gloves when handling waste. If they come into contact with your skin or clothing, wash it off with disinfectant.

Warning! • Pieces of glass may be inside the instrument. When servicing or working with the instrument, pay attention to those pieces of glass.

Important! When performing out maintenance work, use only the specified tools and parts.

2.7 When discarding the waste, disposables and the instrument

Risk of infection

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• To avoid risks of infections, wear protective garments and gloves for all cleaning and maintenance work. After completion of work, disinfect your hands and wash them afterwards. Otherwise, there is a risk of infection by pathogens.

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Safety Information

Warning! • Disposal procedures for residual reagents, detergent, all waste, disposables, parts and instrument must meet all applicable local regulations. • A battery is built-in the Main Unit to maintain the stored data. When discarding the instrument, remove the battery before disposing. Battery may explode if discarding into the fire. The battery is built-in the PCB No. 6374 located in the left side of the Main Unit, as shown in the following figure.

Battery

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PCB No.6374

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Sysmex SP-1000i Instructions for use

Safety Information

2.8 Markings on the instrument Front of the Main Unit (1)

(2)

(3)

(4)

(1)

WARNING! When working with the top cover open, make sure it is in a steady position. Otherwise, the cover may close accidentally and result in injuries.

(2)

WARNING! Never open this cover when the power switch is on. There is a potential to get injured.

(3)

Risks of infection! In principle, all parts and instrument surfaces in contact with blood are potentially biohazardous.

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(4)

WARNING! Do not put your hands inside the instrument when operating. You may get injured by a moving part such as a hand clipper.

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Safety Information Inside of the Main Unit upper part (1)

(2)

(3)

(1)

WARNING! Never put your hands inside when the power switch is on. There is a potential to get injured.

(2)

CAUTION! 1. Do not reach inside the Main Unit while the instrument is running. 2. Pay attention to the direction of the slide glass when inserting it into the slide glass supply cassette.

(3)

PRECAUTION when setting the single slide cassette:

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1. Make sure that the single slide cassette used in smearing, staining and printing manually is dry and contains no slide glass inside. 2. Pay attention to the direction of the cassette. 3. Do not manually push the cassette towards you while the instrument is running.

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Sysmex SP-1000i Instructions for use

Safety Information Rear of the Main Unit (2)

(1)

(3)

(4)

(1)

CAUTION! • To avoid electrical shock, disconnect supply before servicing. • To avoid electrical shock, disconnect supply before replacing the fuse. • For continued protection against risk of fire, replace only with fuse of the specified type and current ratings.

(2)

CAUTION! Do not block the air exhausts on the rear of the Main Unit.

(3)

CAUTION! • Refer to the manual for the connection of tubing, connection cables and power cords. Refer to Chapter 3 "Names and functions of components" for correct connections.

(4)

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Risk of infection! • To avoid risk of infection, wear protective garment and gloves for connecting tubing to the waste outlet nipples and overflow outlet nipples. Those part must be regarded contaminated with bloods, and there is a risk of infection by pathogens. • Should you inadvertently come in contact with potentially infectious materials or surfaces, immediately rinse skin thoroughly with water, and follow your hospital or laboratory's prescribed cleaning and decontamination procedures.

Sysmex SP-1000i Instructions for use

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Safety Information

Pneumatic Unit (1)

Risk of infection! • In principle, all parts and instrument surfaces in contact with blood is potentially biohazardous.

(1)

(1)

CAUTION • Do not block the exhausts on the rear of the Pneumatic Unit. • Do not install the Pneumatic Unit on the same bench as the Main Unit. There is a potential that the smear may be undulated due to the vibrations.

(1)

(2) (1)

(2)

WARNING • To avoid electrical shock, disconnect supply before servicing. • To avoid electrical shock, disconnect supply before replacing the fuse. • For continued protection against risk of fire, replace only with fuse of the specified type and current ratings. Reagent containers (1) The meanings of abbreviations on the labels on the containers are as follows. DW: DI Water M: Methanol

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(1)

Sysmex SP-1000i Instructions for use

Safety Information

2.9 Personnels

Caution! • Those who have little or no experience operating the SP-1000i are expected to use the instrument under the guidance and assistance of an experienced operator. • If the instrument is out of order, the instrument administrator is expected to provide the necessary services and replacements that are described in this manual. For further repairs, please contact your Sysmex service representative. • Unpacking, installation and confirmation of initial operation are carried out by your dealer or local Sysmex representative.

2.10 Host computer connection

Caution!

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If orders are to be downloaded from the host computer, start making smears only after all orders for the target rack have been downloaded. If making smears has started before completing the download, this may sometimes start to make smears before receiving orders, which could happen depending on the transmission speed. Should this happen, the instrument will make smears using the default sample ID number and default smearing conditions.

Sysmex SP-1000i Instructions for use

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