i SENS ISMART300A User Manual

Operator’s Manual

Software version 1.0.0.0

P/N 7983 Draft

July 2015

Copyright © 2015 i-SENS, Inc. All Rights Reserved

Operators should read the entire manual

before installing and operating the analyzer.

Contents

1 Introduction

Safety ··························································································· 1-1

Symbols and Terms ············································································· 1-3

Product Description ············································································ 1-5

2 Installation

Installation Requirements ······································································ 2-1

Power Cable Connection ······································································· 2-2

Power-On ······················································································· 2-3

Printer Paper Installation ······································································· 2-5

Cartridge Installation ··········································································· 2-7

3 Analyzer Settings

Contents

Screen Menus ··················································································· 3-1

Sample Setup ·················································································· 3-10

QC Setup ······················································································ 3-15

Analyzer Setup ················································································ 3-17

Interface Setup················································································· 3-21

4 Sample Analysis

Patient Samples ················································································· 4-1

QC Samples ···················································································· 4-8

5 Database

Patient Data ····················································································· 5-1

QC Data ························································································ 5-5

Calibration Data ················································································ 5-9

Cartridge Data ················································································· 5-12

Contents

6 Shutdown

Analyzer Shutdown ············································································· 6-1

Cartridge Restart ················································································ 6-3

7 Maintenance

Calibration ······················································································· 7-1

Cartridge Removal ·············································································· 7-4

System Information ············································································· 7-6
Analyzer Status ············································································· 7-7
Cleaning ···················································································· 7-8

8 Troubleshooting

Troubleshooting ················································································· 8-1

Error Code ······················································································· 8-6

9 Specification

Operating Specification ····································································· 9-1
Analyzer Specification ····································································· 9-2
Cartridge Specification ····································································· 9-3
Measuring Principles ······································································· 9-4

Appendices

Appendics A: Sample Collection and Handling ·············································· 10-1
Appendics B: Order Information ····························································· 10-2
Appendics C: Warranty ······································································· 10-3

1. Introduction

Safety ··················································································· 1-1

Symbols and Terms···································································· 1-3

Product Description ··································································· 1-5

1. Introduction

1. Introduction

Safety

General
Warnings

General
Caution

 Use only the provided power cord and adapter.

 Do not use damaged power cord, adapter, or loose outlet.

 Never touch the power supply accessories with wet hands.

 Keep dust away from the outlet and power cord.

 Do not use or store any hot equipment or flammable material

near the analyzer or power supply accessories.

 Do not allow water or foreign substances to get into the analyzer

or power supply accessories.

 Do not directly look at the red light emitting from the barcode

scanner as direct eye exposure to this light can damage vision.

 Power cord must be plugged into a grounded outlet.

 The rear vent of the analyzer must be free of obstruction and not

covered by cloth or any other material.

 Do not install or operate the analyzer in an area where

ferromagnetic fields are generated (e.g., the MRI room).

 Before long term storage of the analyzer, remove the cartridge,

turn off the power, and clean any contamination from the
analyzer.

 There are no operator seviceable parts inside the product.

Do not disassemble, repair, or modify the product.

 If electromechanical problems are suspected, call a service

engineer to report the problems.

 When disposing the analyzer and provided electrical accessories,

contact your local distributor where you purchased them.
You must not discard this electrical/electronic product in
domestic household waste.

 Changes or modifications not expressly approved by i-SENS, Inc.

could void the purchaser’s authority to operate the equipment.

1-1 i-Smart 300 Blood Gas Analyzer

Safety, continued

1. Introduction

Biohazard
Caution

 All materials used in collecting blood and/or other samples from

humans should be treated as biohazardous materials with the
potential carrying infectious agents capable of producing disease.

 All biohazardous materials should be handled and disposed of in

accordance with applicable rules and regulations of the hospital,
laboratory, or other testing facility.

 Wear appropriate personal protective clothing (lab coat, gloves,

goggles, etc.) before operating the analyzer.

 Be careful not to let the sample and/or collecting tools directly

touch the mouth, eyes, mucus membranes, or any area with
broken skin.

 Wash hands after collecting the sample or using the analyzer.

Operator’s Manual 1-2

1. Introduction

Authorized representative in the European

This marking indicates that you must not discard

DC power port

Off (power)

On (power)

Symbols and Terms

Symbols

Symbol Description

CE mark (In Vitro Diagnostic Directive 98/79/EC)

In vitro diagnostics device

Consult operating instructions

community

Serial number

Caution: Attention, see operating instructions

Manufacturer

Temperature limitation

Catalogue number

Batch code

Contains sufficient for <n> tests

Use by

Biological risk

this electrical/electronic product in domestic
household waste. Distributors of this product
within the EU have taken the necessary step to
comply with the Waste Electrical and Electronic
Equipment (WEEE), Directive 2002/96/EC.

Printer

1-3 i-Smart 300 Blood Gas Analyzer

Symbols and Terms, continued

A statement that alerts the operator to

the

1. Introduction

Terms

Term Description

pH

pCO2

pO2

cNa+

cK+

cCa2+

cCl-

Hct

Cal

Cal 1

Cal 2

Negative log of the hydrogen ion activity

Partial pressure of carbon dioxide

Partial pressure of oxygen

Concentration of sodium ion

Concentration of potassium ion

Concentration of calcium ion (ionized calcium)

Concentration of chloride ion

Hematocrit

Calibration

1-Point calibration

2-Point calibration

QC

Warning

Caution

Quality control

A statement that alerts the operator to the
possibility of injury, death, or other serious
adverse reactions associated with the use or
misuse of the device.

possibility of device malfunction, device failure,
damage to the device or damage to other
property associated with the use or misuse of the
device.

Operator’s Manual 1-4

1. Introduction

cover

scanner

Handle

Product Description

Intended Use

Analyzer

i-Smart 300 is an automated system that measures pH, pCO2, pO2,
cNa+, cK+, cCl-, cCa2+, and hematocrit in whole blood.

It is intended for use in a point-of-care setting or laboratory
environment.

Touchscreen

Barcode

Sampler

Cartridge

door

Printer

VGA port

LAN port

Power switch

Power port

Serial port

Vent

USB ports

i-Smart 300 Analyzer

1-5 i-Smart 300 Blood Gas Analyzer

Product Description, continued

1. Introduction

Accessories of

analyzer

Cartridge

Power adapter Power code

Printer papers

Cartridge cover

i-Smart 300 Cartridge

Operator’s Manual 1-6

1. Introduction

This page is intentionally left blank.

1-7 i-Smart 300 Blood Gas Analyzer

2. Installation

Installation Requirements ··························································· 2-1

Power Cable Connection ···························································· 2-2

Power-On ············································································· 2-3

Printer Paper Installation ····························································· 2-5

Cartridge Installation ·································································· 2-7

2. Installation

2. Installation

Installation Requirements

Unpacking

Environmental
Requirements

 Inspect the shipping package of the product for any signs of

damage from shipment.

 Ensure all listed components are included in the package.

 Location : indoors

 Temperature : 15 ~ 35°C

 Humidity : 5 ~ 85%, relative humidity

 Altitude : under 3,000 m

Note:

 The analyzer should be installed on a horizontal, stable surface in

a well-ventilated area without direct sunlight or heat.

 Allow enough space for the cartridge door of the analyzer to

open.

 Allow at least 10 cm of space from the back of the analyzer for

adequate ventilation.

 This equipment has been tested and found to comply with the

limits for a Class A digital device, pursuant to part 15 of the FCC
Rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and
can radiate radio frequency energy and, if not installed and used
in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the
interference at his own expense.

Electrical

 Volt AC : 100 ~ 240 Va.c., grounded electrical supply

Requirements

 Amp : 1.5 A

 Frequency : 50/60 Hz

 Power cord : 3-wire, approved

 Power adapter : +24 Vd.c., 2.7 A (Output)

2-1 i-Smart 300 Blood Gas Analyzer

Power Cable Connection

2. Installation

Caution

Connect Power
Cable

 Check that the power switch is in “ ” (OFF) position.

 Always connect the power according to the steps described in

this manual.

 Always use a grounded electrical outlet.

 Use only the power cord and power adapter provided by the

manufacture.

 Electrical plugs and sockets vary by countries. If necessary, use

appropriate power plug or power strips to connect the provided
power cord to the outlet.

1. Plug the power cord into the socket of the power adapter.

2. Plug the power adapter into the power port on the back of the

analyzer.

3. Plug the power cord into an electrical outlet.

Operator’s Manual 2-2

2. Installation

Power-On

Caution

Turn Power
Switch On

 Remove any attached USB memory device or network cable

from the analyzer before turning the power switch on.

2. Facing the back of the analyzer, flip the black power switch on

the lower left side, marked “ ” to the “ ” position.

3. The screen will turn on and the analyzer will boot.

4. If the boot is completed, the message of the last shutdown

information will appear.

2-3 i-Smart 300 Blood Gas Analyzer

Power-On, continued

2. Installation

Turn Power
Switch On,
continued

5. Check that the power cord icon 이 appears at the bottom

row of the screen.

Note:

 If the power cord icon does not appear on the screen,

check for any loose power connections between the analyzer and
the electrical outlet.

 If no loose power connection is found and the power cord icon

still does not appear, call a service engineer immediately.

6. Check the date and time of the analyzer and, if necessary, change

date and/or time. Refer to 3. Analyzer Settings

Note:

 Changing the date and time of the analyzer is only allowed

before cartridge is installed on the analyzer. Once the cartridge
is installed, the date and time cannot be changed until the
cartridge is removed.

Operator’s Manual 2-4

2. Installation

Printer Paper Installation

Install Printer
Paper

1. Facing the back of the analyzer, push the PUSH button and flip

down the printer cover.

2. Place the paper roll into the paper compartment and place the end

of the paper in parallel with the printer slot.

2-5 i-Smart 300 Blood Gas Analyzer

Printer Paper Installation, continued

2. Installation

Install Printer
Paper, continued

3. Close the printer cover.

Note:

 The printer will cut the paper exposed to the outside

automatically.

Operator’s Manual 2-6

2. Installation

Cartridge Installation

Install Cartridge Note:

 After opening the cartridge, it must be installed directly to the

analyzer.

1. Take out the cartridge from the cartridge box.

2. Press down the cover lock and remove the cartridge cover.

3. Press Install at the following screen

4. Slide down the lever on the cartridge door, open the cartridge

door.

2-7 i-Smart 300 Blood Gas Analyzer

Cartridge Installation, continued

2. Installation

Install Cartridge,
continued

5. Insert the new cartridge into the analyzer, follow the instructions

on the screen.

6. Facing the cartridge label, insert the cartridge into the analyzer.

7. Close the cartridge door and slide up the lever on the cartridge

door. If the door is properly locked, it will make a clicking sound.

Operator’s Manual 2-8

2. Installation

Cartridge Installation, continued

Install Cartridge,
continued

8. If the RFID tag information of the cartridge is valid, the analyzer

will change to the Cartridge Warming-Up screen.

9. The cartridge warming-up will take approximately 25 minutes.

Note:

 Once the cartridge cover is removed, be careful with sharp edges

of the cartridge parts inside.

2-9 i-Smart 300 Blood Gas Analyzer

3. Analyzer Setting

Screen Menus ·················································································· 3-1

Sample Setup ·················································································· 3-10

QC Setup ······················································································· 3-15

Analyzer Setup ··············································································· 3-17

Interface Setup ················································································ 3-21

3. Analyzer Setting

3. Analyzer Setting

Screen Menus

Ready Screen

No.

Screen naming

①

Analyzer operation schedule

②

Remaining sample number and date of the installed cartridge

③

Current state of interface setup

④

Current state of power connection

⑤

Current state of and battery recharge level

⑥

Current date and time of the analyzer

⑦

Menu access

⑧

Current state of each sensor:
Pressing each button twice will display the latest slope of the

⑨

sensor.

Description

3-1 i-Smart 300 Blood Gas Analyzer

Screen Menus, continued

3. Analyzer Setting

Menu options

Operator’s Manual 3-2

3. Analyzer Setting

Screen Menus, continued

Menu Access

1. Press Menu. The quick menus and the category menus will appear.

2. Press the current screen box at the top right corner to show the

current menu options.

Note:

 The Menu button is disabled on the following screens:

- Install Cartridge, Remove Cartridge

- Introduce Sample, Sample Information, Sample Results

- Introduce QC Sample, QC Information, QC Results

3-3 i-Smart 300 Blood Gas Analyzer

Screen Menus, continued

3. Analyzer Setting

Icons and
Buttons

Icons and Buttons Description

Print results or settings on

Transmit results to LIS/HIS /

screen

Transfer complete

Close current screen

Go to list screen

Go to search screen

View result screen

Operator’s Manual 3-4

Scroll to previous or next page

Go to previous or next result

screen

3. Analyzer Setting

Screen Menus, continued

Icons and
Buttons,
continued

Icons and Buttons Description

Delete entered data on current

Execute search

Run 1-point calibration or

2-point calibration

Run QC

Accept or discard QC results

Add or delete QC lot

information

tab

Okay or accept

Save

Go to previous screen

Copy cartridge data to USB

memory

3-5 i-Smart 300 Blood Gas Analyzer

Screen Menus, continued

3. Analyzer Setting

Icons and
Buttons,
continued

Icons and Buttons Description

Unselected item

Selected item

Item that were transmitted to

Show keyboard for data entry

Show keyboard for numeric

LIS/HIS

Selected item that were

transmitted to LIS/HIS

entry

Operator’s Manual 3-6

Interface was enabled

Analyzer is on AC power

Battery level

3. Analyzer Setting

Screen Menus, continued

Keyboards

The analyzer offers following keyboards for data entry.

Alphabetic Keyboard

Numeric & Special Character Keyboard

Date and Time Entry Keyboards

3-7 i-Smart 300 Blood Gas Analyzer