iSens i-SmartCare 10 User manual

PZA1O7619 REV7
2020 - 12
Operator’s
Manual
Operator’s Manual

Software version 1.0.5.0
PZA1O7619 REV7
2020. 12
i-SENS, Inc.
27-36, Gwangun-ro, Nowon-gu, Seoul 01891, Korea
Medical Technology Promedt Consulting GmbH
Altenhofstrasse 80
66386 St. Ingbert, Germany
Copyright © 2020 i-SENS, Inc. All Rights Reserved

Please take time to read this operator’s manual
before setting up and operating the analyzer.

Table of Content
Table of Contents
1 Introduction
4 Sample Analysis
2 Installation
5 Database
3 Instrument Settings
Safety .................................................................................................................................... 8
Symbols and Terminology................................................................................................... 10
Product Description ............................................................................................................13
Start Analysis....................................................................................................................... 68
Blood Sample...................................................................................................................... 69
QC Sample .......................................................................................................................... 78
Installation Requirements.................................................................................................... 16
Power Cable Connection .................................................................................................... 17
Power-on............................................................................................................................. 18
Printer Paper Installation .....................................................................................................20
Cartridge Installation ........................................................................................................... 22
Sample Data........................................................................................................................ 86
QC Data............................................................................................................................... 90
Calibration Data................................................................................................................... 96
Cartridge Data ..................................................................................................................... 97
Screen Menu ....................................................................................................................... 28
Instrument Setup................................................................................................................. 37
Parameter Setup ................................................................................................................. 46
Parameter Group Setup ...................................................................................................... 48
Unit Setup ........................................................................................................................... 50
Sample Setup...................................................................................................................... 52
QC Setup............................................................................................................................. 58
L-J Chart Setup................................................................................................................... 61
Interface Setup.................................................................................................................... 63
Language Setup .................................................................................................................. 66

Table of Content
9 Product Specification
7 Maintenance
Appendices
8 Troubleshooting
6 Shutdown
Analyzer Shutdown ........................................................................................................... 100
Power Recovery ................................................................................................................ 102
Operation Specifications ................................................................................................... 124
Instrument Specifications.................................................................................................. 126
Cartridge Specifications.................................................................................................... 127
Principles........................................................................................................................... 128
Calibration ......................................................................................................................... 104
Cartridge Removal ............................................................................................................ 106
Cartridge Information ........................................................................................................ 109
System Information ........................................................................................................... 110
Event Log .......................................................................................................................... 111
Analyzer Status ................................................................................................................. 112
Cleaning ............................................................................................................................ 114
Appendix A: Collecting and Handling Samples ................................................................ 129
Appendix B: Order Information ......................................................................................... 130
Appendix C: Warranty ....................................................................................................... 132
Troubleshooting ................................................................................................................ 116
Error Code......................................................................................................................... 122

1. Introduction
1. Introduction
Safety ......................................................................................................................................8
Symbols and Terminology ....................................................................................................10
Product Description ..............................................................................................................13

1. Introduction
8 i-SmartCare 10 Blood Gas Analyzer
Safety
General
Warnings
• Use the provided power adapter and power cord only.
• Do not use damaged power cord, power adapter or loose electrical
outlet.
• Do not touch the power supply including power cord and power
adapter with wet hands.
• Please keep the power adapter and the electrical outlet dust free.
• Do not leave any heating equipment or highly flammable materials near
the analyzer or the power supply.
• Make sure to keep the analyzer away from water or any other liquid
substances.
• Do not open or disassemble the analyzer
• Barcode scanner uses an LED light source.
Direct exposure to the infrared light may cause retina injury.
Do not look directly into the light source.
General
Caution
• Make sure to connect the power cord to grounded electric outlet.
• Do not cover or block the vent located in the back of the analyzer.
• Do not install or operate the analyzer near the area with strong
magnetic field(i.e: MRI device)
• When the analyzer needs to be stored for a long time, the cartridge
must be taken out.
• Make sure to disconnect the power and to clean the unit before
storage. (Please refer to 7. Maintenance > Cleaning)
• If the analyzer is inoperable, call the maintenance personel or i-SENS.
• Do not open, dissemble, repair or modify the unit on your own.
• Contact your local distributor for recycling procedure under the
environment protection and resource recycling regulations.

Operator's Manual 9
Safety,continued
1. Introduction
Biohazard Caution • All biohazard materials must be handled and/or discarded in
accordance with the instructions from hospitals, clinical labs, or testing
facilities.
• Always protect yourself with proper safety gear such as lab gown,
protective gloves, goggles, etc.
• Please wash your hands after using the analyzer.

1. Introduction
10 i-SmartCare 10 Blood Gas Analyzer
Symbols and Terminology
Symbols Symbol Description
CE Mark
In vitro diagnostics device
Consult instructions for use
Serial number
Caution: Attention, see operating instructions
Authorized representative in the European community
Manufacturer
Temperature limitation
Humidity limitation
Catalogue number
Batch code
Contains sufficient for <n> tests
Use by (Expiration Date)
Biological risks
This marking indicates that you must not discard 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.

Operator's Manual 11
Symbols and Terminology,continued
Symbols,
continued
1. Introduction
Symbol Description
Printer
DC Power port
Power off
Power on
This way up: indicates correct upright position of the
transport package.
Keep dry
Fragile, handle with care
Stacking limit by number: maximum number of
identical packages which may be stacked on one
another

12 i-SmartCare 10 Blood Gas Analyzer
Symbols and Terminology,continued
1. Introduction
Terminology Terminology Description
pH Negative log of the hydrogen ion activity
pCO2Partial pressure of carbon dioxide
pO2Partial pressure of oxygen
Na+Sodium ion
K+Potassium ion
Ca2+ Calcium ion
Cl-Chloride ion
Hct Hematocrit
Glu Glucose
Lac Lactate
Cal Calibration
1 Point Cal 1-Point Calibration
2 Point Cal 2-Point Calibration
O2Cal O2Calibration
QC Quality control
EEPROM electrically erasable programmable read-only memory
Warning
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.
Caution
A statement that alerts the operator to the possibility
of device malfunction, device failure, damage to the
device or damage to other property associated with
the use or misuse of the device.

1. Introduction
Operator's Manual 13
Product Description
Intended Use The i-SmartCare 10 Blood Gas Analyzer measures gas (pCO2, pO2), pH,
electrolytes (Na+, K+, Ca2+, Cl-), hematocrit (Hct) and metabolites (Glu, Lac)
in whole blood samples.
The i-SmartCare 10 Blood Gas Analyzer is intended for in vitro diagnostic
use and for use by healthcare professionals.
Analyzer
Touch Screen
Sampler
Barcode Scanner
Cartridge door
Printer
HDMI port
Handle
Serial port
Vent
LAN port
USB port
Power port
Power switch
i-SmartCare 10 Blood Gas Analyzer

14 i-SmartCare 10 Blood Gas Analyzer
Product Description,continued
1. Introduction
Analyzer,
Accessories
Power adapter Power cord
Printer Paper
Cartridge
Cartridge Cover
CarePak Cartridge

2. Installation
2. Installation
Installation requirements.......................................................................................................16
Power Cable Connection ......................................................................................................17
Power-On..............................................................................................................................18
Printer Paper Installation.......................................................................................................20
Cartridge Installation.............................................................................................................22

2. Installation
16 i-SmartCare 10 Blood Gas Analyzer
Installation requirements
Unpacking • Inspect the shipping package of the product for any signs of damage
from shipment.
• Ensure all listed components are included in the package.
Environment • Set-up Location : Indoor
• Operating Temperature : 15 ~ 35 °C
※It has been confirmed that i-SmartCare 10 is safe to operate in the
range of 5 ~ 40 °C according to IEC 61010-1. The recommended range
is from 15 to 35 °C for the desirable performance.
• Operating Humidity : 5 ~ 85 %, relative humidity
• Operating Altitude : Below 3,000 m
Note:
Keep the analyzer away from sunlight or heat, and place it on flat,
stable surface with good air circulation.
Allow at least 10 cm of space at the back of the analyzer for
adequate air circulation.
Electric Power • Volt AC : 100 ~ 240 Va.c., grounded power supply
• Electric Current : Max. 2.7 A
• Frequency : 50/60 Hz
• Power Cord : 3-wire, approved
• Power adapter : +24 Vd.c., 2.7 A (Output)

2. Installation
Operator's Manual 17
Power Cable Connection
Caution • Make sure the power switch is in “ ” (OFF) position.
• Always use a grounded electrical outlet.
• Use the provided the power cord and power adapter only.
Connect to power 1. Plug the power cord into power adapter’s socket.
2. Connect the adapter to the power port in the back of the analyzer.
3. Connect the power cord to the electrical power outlet.

2. Installation
18 i-SmartCare 10 Blood Gas Analyzer
Power-On
Caution • Before turning on the analyzer, please remove all USB memory or
network cable from the analyzer.
Turn on the power 1. Turn on the power by pushing the switch on the back.
2. The LCD screen is turned on and the analyzer will start booting.
3. Once the booting is complete, the main screen appears.
Note:
When the analyzer is started without a cartridge, “No cartridge”
status appears.
If the unit is rebooted with a usable cartridge, “Cartridge Restart”
automatically performs.
If the unit is rebooted with a unusable cartridge, “Expired Cartridge”
status appears.

Operator's Manual 19
Power-On,continued
Turn on the power,
continued
2. Installation
4. Please check if the power connected icon is indicated on the top
of the screen.
Note:
If the power connected icon does not appear, please check
whether or not the power cable is properly connected.
If the power connected icon does not appear even after the power
cable is properly connected, please contact our service teams.
5. Check the analyzer’s time and date. If the time and date are
incorrect, you can change them as follows: 3. Instrument Settings >
Instrument Setup > Date and Time.
Note:
The time and date information can only be changed without
cartridge. Once the cartridge is installed, it is no longer to be
changed.