Skyla HB1 Manual de usuario

skyla

Clinical Chemistry Analyzer

HB1

Operator’s Manual

For In-Vitro Diagnostic Use Only

Technical support and customer service information:

Tel: +886-3-611-8511

Fax: +886-3-579-5393

E-mail: support@skyla.com

Website: www.skyla.com

Manual Text, Rev. 1B

PN: 7B25000005HB

LITE-ON

Technology

Corp. H.S.P.B.

No. 8, Dusing Road, Hsinchu Science Park

Hsinchu, Taiwan, R.O.C.

MT Promedt Consulting

GmbH

Altenhofstr. 80

D-66386 St. Ingbert

Germany

Table of Content

SECTION 1: GENERAL INFORMATION .......................................... 1-1

1.1 Overview ..................................................................................... 1-1

1.2 Universal Precautions .................................................................. 1-1

1.3 Introduction ................................................................................. 1-2

1.4 Technical Support ....................................................................... 1-3

1.5 Consumables and Supplies .......................................................... 1-3

1.6 Understand the Symbols.............................................................. 1-3

SECTION 2: SETUP AND QUICK START ......................................... 2-1

2.1 Pre-installation Check ................................................................. 2-1

2.2 Specifications and Installation Characteristics ............................ 2-3

2.3 Installation and Setup .................................................................. 2-4

2.4 Touchscreen Interface ................................................................. 2-6

2.5 Power-On and Initialization ........................................................ 2-8

2.6 Maintenance and cleaning ......................................................... 2-11

SECTION 3: SAMPLE ANALYSIS ....................................................... 3-1

3.1 Functions of Reagent Disc .......................................................... 3-1

3.2 Sample Preparation ..................................................................... 3-2

3.3 Preparation Before Testing.......................................................... 3-4

3.4 Dispensing the Sample ................................................................ 3-6

3.5 Performing a Test ........................................................................ 3-8

3.6 Test Results ............................................................................... 3-10

3.7 Reviewing the Test Results ....................................................... 3-11

3.7.1 Symbols Used in Test Reports .................................. 3-12

3.7.2 Symbols Used in internal QC Reports ...................... 3-15

3.8 Custom Reports ......................................................................... 3-17

3.9 Performing Quality Control ...................................................... 3-18

3.9.1 Selecting an External Control ................................... 3-19

3.9.2 Using a skylaTM Reagent Disc for the Quality

Control Test ............................................................. 3-19

3.9.3 Performing a Quality Control Test............................ 3-19

3.9.4 Quality Control Test Results .................................... 3-20

SECTION 4: REVIEW OF HISTORICAL DATA & OPERATION

INFORMATION ............................................................... 4-1

4.1 Review of Historical Data (Recall) ............................................. 4-1

4.1.1 Searching for Test Records (Search) ...........................4-1

4.1.2 Browsing Test Results (Browse) ................................4-4

4.1.3 Searching for System Quality Control Test Records

(Controls) ..................................................................4-5

4.2 Help Information ......................................................................... 4-6

SECTION 5: SYSTEM SETTINGS ....................................................... 5-1

5.1 System Settings ........................................................................... 5-1

5.1.1 System Version ..........................................................5-1

5.1.2 Printer Selection ........................................................5-1

5.1.3 Screen Brightness Adjustment ....................................5-2

5.1.4 eGFR value ................................................................5-2

5.1.5 Control (Performing Quality Control) ........................5-3

5.1.6 Custom Report ...........................................................5-3

5.2 Administrator Settings: ............................................................... 5-4

5.2.1 Screen Calibration .....................................................5-6

5.2.2 Date & Time ..............................................................5-7

5.2.3 Reference Range ........................................................5-7

5.2.4 Marker Unit ...............................................................5-9

5.2.5 Backup Records ....................................................... 5-10

5.2.6 System Upgrade ....................................................... 5-10

iii

5.2.7 Password Change ..................................................... 5-11

5.2.8 System Default ........................................................ 5-12

5.2.9 Operator Control ...................................................... 5-12

5.2.10 Operator List............................................................ 5-13

5.2.11 Operator Creation .................................................... 5-13

5.2.12 RS232 Baud Rate Setting ......................................... 5-14

5.2.13 Demo Mode ............................................................. 5-14

5.2.14 QC Report ............................................................... 5-15

5.2.15 Buzzer ..................................................................... 5-15

5.2.16 Hospital Name ......................................................... 5-16

5.2.17 Patient Name ........................................................... 5-16

5.2.18 Language ................................................................. 5-17

5.2.19 Automatic Printing ................................................... 5-17

5.2.20 Save Log to USB ..................................................... 5-17

5.2.21 & 22 Export Databse & Import Databse ................... 5-18

5.2.23 Error Log ................................................................. 5-18

SECTION 6: TROUBLESHOOTING & ERROR HANDLING......... 6-1

6.1 Troubleshooting .......................................................................... 6-1

6.2 Error Messages & Handling ........................................................ 6-3

APPENDIX I: RS232 COMMUNICATION PROTOCOL

SPECIFICATIONS ....................................................... A-1

APPENDIX II: BACKUP RECORDS DATA EXPORT

SPECIFICATIONS ....................................................... B-1

1-1

skylaTM

Clinical Chemistry Analyzer

skylaTM Reagent Discs

(Reagent discs must be stored at

temperatures between 2 to 8°C)

Section 1: General Information

1.1 Overview

The skylaTM Clinical Chemistry Analyzer, together

with

its exclusive H

B1 reagent disc series, offers a quick,

easy and accurate method

to measure various

biochemical markers in whole blood, plasma, or serum.

CAUTION :

1. If the skylaTM Clinical Chemistry Analyzer

operated in any manner different

from those

described in this manual, the analyzer may

produce no or inaccurate results.

If used outside

safe design limits, the skylaTM

Clinical

Chemistry Analyzer

may not function as

intended and may be hazardous.

2. The skylaTM Clinical Chemistry Analyzer

should

only be used with skylaTM HB1 series of

reagent

discs.

1.2 Universal Precautions

As the use of this device involves clinical blood

samples

, health and safety regulations require that

Universal Precautions be observed at all times when

handling the samples

. Handling of used reagent discs

and the parts of the analyzer that may have

come into

contact with samples must be treated in accordance w

ith

relevant legal regulations in the locality or

standard

operation procedures of affiliated units.

1-2

1.3 Introduction

The skylaTM Clinical Chemistry Analyzer

provides

clinical testing laboratories of medical facilities

and

clinics with an in-vitro clinical chemistry diagnostic

tool

that is compact, portable, and reports

rapid results. The

portable design of the clinical chemistry analyzer

utilizes

precision photometric

measurement technology,

combined with the use of specific reagent discs. The

reagent disc contains a set of dry assay reagents

that are

used in the quantitative testing of various biomarkers in

the blood sample.

Features of the clinical chemistry analyzer include:

 Compatibility with lithium-

heparinized whole blood

samples without the need for sample dilution.

 Operation by a colored touchscreen panel.

 Fully automated system for simple operation.

 Rapid analysis, reporting

test results in approximately

15 minutes.

 Testing a maximum of 15 blood

clinical chemistry

markers in a single analysis.

 Power-on self-test capability, ensuring

instrument

stability.

 Internal quality control functionality, ensur

ing

reliable test results.

 Built-in thermal printer for immediate printing of

the

test results.

 A USB interface for connecting to an external printer

or exporting the test results.

 A RS232 interface for connecting with

external

instruments or computers.

 A USB interface supporting an

externally connected

barcode scanner for patient record numbers.

 A RJ45 LAN port for communication with

external

PC networks.

The reagent disc is a round plastic disc that contains dry

assay

reagents. The automated operation protocol of the

1-3

analyzer includes blood separation, sample

dilution, and

reagent reaction in the reagent disc. Optical

signals are

then analyzed by the analyzer to obtain the test results

Use of the skyla

Clinical Chemistry Analyzer

does

not require complex operational training.

Note: The clinical chemistry analyzer

screen

captures

displayed in this manual are for

illustration only, and may differ from system

displays during actual operations.

Warning:

Please do not attempt to

disassemble or repair the

skyla

Clinical Chemistry

Analyzer by yourself. This will

void the warranty.

Technical Support &

Customer Service

Contact Tel:

Tel: +886- 3- 6118511

Fax: +886- 3- 5795393

E-mail: support@skyla.com

1.4 Technical Support

skyla

technical support personnel of skyla

(or

authorized agents) are available to assist users

regarding the operation of the skyla

Clinical

Chemistry Analyzer.

1.5 Consumables and Supplies

To order consumable supplies or additional accessories,

please contact the customer service representatives

authorized distributors.

1.6 Understand the Symbols

The definitions of symbols found on the skyla

Clinical Chemistry Analyzer and

its peripherals are as

follows:

In Vitro Diagnostic Medical Equipment

Caution

Biohazard. Please strictly

adhere to laboratory practices

when handling blood and body fluid samples;

consider

all samples

to be potentially infectious and handle them

1-4

with caution. Please refer to the biological medical

waste disposal regulations of the locality.

Do not reuse

EC authorized representative

Date of manufacture

Manufacturer

Temperature limits (2-8°C)

Use by date

Serial number

Lot number

Consult instructions for use

Direct current

RJ45 LAN network connection

IOIOI

RS232 serial port

USB port

Power button

2-1

Package Checklist

 Clinical chemistry analyzer

 Power adapter & power

supply cord

 One roll of thermal printer

paper

 200 μL micropipette

 One box of pipette tips

(96 tips)

 Operator’s manual

 Quick guide of operation

 Quick guide of error code

 Warranty card

 External barcode scanner

and stand (optional)

 USB-to-RS232 connection

cord (optional)

Section 2: Setup and Quick Start

2.1 Pre-installation Check

Remove the skyla

Clinical Chemistry Analyzer

from the shipping box

. Place the analyzer on a clean

surface off the floor. Do not expose the analyzer to

direct sunlight or any heat source.

Please refer to the checklist on the

left and check that

the components and other peripherals received with

the analyzer are present.

Checklist

No.

Item Picture of Item

Clinical Chemistry analyzer

Power adapter & power

supply cord

Roll of thermal printer paper

200 μL micropipette

One box of pipette tips (96

tips)

Operator’s manual

Quick guide of operation

Quick guide of error code

Warranty card

2-2

External barcode scanner

and stand (optional)

USB-to-RS232 connection

cord (optional)

3. After the successful setup, fill in

the warranty card

and mail it to LITE-ON Technology Corp. H.S.P.B

or email to support@skyla.com for

receiving

periodic mail or email regarding software upgrades

and skylaTM Clinical Chemistry Analyzer

product

information.

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