Iflash 1200 Installation Guide

iFlash 1200
Automatic Chemiluminescence
Immunoassay Analyzer
Installation Guide
Shenzhen YHLO Biotech Co., Ltd. (SSE STAR Stock Code: 688575)
Address: YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, 518116 Shenzhen, P.R.China
After-sales service provider: Shenzhen YHLO Biotech Co., Ltd.
Tel: 86-755-26473359-836 Fax: 86-755-26473319
Shenzhen YHLO Biotech Co., Ltd.
Change History
Version EPT Number Description Revised By

A/0 / Initial release Yi.
A/1 / Revise and modify Peter
YHLO/AF-12-iF10-001/A0
Intellectual Property Rights

Shenzhen YHLO Biotech Co., Ltd. ("YHLO") owns the intellectual property rights in this manual and the
corresponding products. Without written permission from YHLO, no one shall photograph, copy, photocopy,
distribute, tamper, translate or otherwise reproduce any or all information in this manual.
YHLO reserves the right of final interpretation of this manual.

YHLO reserves the right to modify the manual without prior notice.
YHLO reserves the right to change the technologies without prior notice.
YHLO reserves the right to change the product specifications without prior notice.
Disclaimer
YHLO is responsible for the safety and reliability of the device only when the following conditions are met:
 Assembly, expansion, commissioning, improvement and maintenance are all carried out by personnel
approved by YHLO.
 Relevant electrical equipment conforms to the national standards.
 The instrument is used in compliance with the product manual.
 YHLO is not liable for the safety and reliability of the product in the following cases:
 Unauthorized personnel disassemble, repair and debug the product.
 The product is not used in compliance with the product manual.
After-Sales Service Provider

Customer Service Center, Shenzhen YHLO Biotech Co., Ltd.
Address: Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, 518116
Shenzhen, P.R.China
Service hotline: 400-166-0755

Email: service@szyhlo.com
Tel: 86-755-26473359
Fax: 86-755-26473319
About This Guide

Scope of Application
This document only applies to authorized personnel who have received product training and related certification.
Unauthorized use of this document is prohibited.
This document is only applicable to the installation of iFlash 1200-A and iFlash 3000-M analyzers.
Symbols
The following symbols are used in this document.
Symbols Description
Biological risks
Warning Read the instructions carefully. Improper operation

may lead to personal injury.
Caution Read the instructions carefully. Improper operation

may cause damage to the instrument.
Note Read the instructions carefully. Improper operation

may result in faults.
The following symbols can be found on the instrument packaging or reagent packaging.
Symbols Description
Danger
The presence of this symbol on an instrument
component indicates a danger in the vicinity that may
result in death or serious injury.
Biological risks
The presence of this symbol on an instrument
component indicates a potential risk of infection in the
vicinity.
Relevant laboratory safety measures must be
observed.
Laser radiation
This symbol is located next to the sample barcode
scanner and the reagent barcode scanner. Meaning: Do
not look directly at the beam.
Moving parts
This symbol indicates the moving part of the
instrument. Meaning: Do not touch this part.
Otherwise, it may cause personal injury or damage to
the instrument.
Electric shock
This symbol indicates that contact with the relevant
parts of the instrument may result in electric shock,
which may endanger life in serious cases. Therefore,
only designated and qualified electricians are allowed
to repair and replace the parts of the instrument.
Network interface
USB interface
For In vitro diagnostic medical device
Product number
Batch code
Date of manufacture
Use-by date
Warning
Consult instructions for use
Temperature limit
Relative humidity limit
Atmospheric pressure limit
Fragile
This side up
Keep dry
Stacking limit by number
References
1. iFlash 1200 Automatic Chemiluminescence Immunoassay Analyzer Operation Manual
2. iFlash 1200 Automatic Chemiluminescence Immunoassay Analyzer Service Manual
Version Information
Document version: A/1
Software version: V1.00.02.00.17
Release date: October 2021
Biological Risks
 Samples, controls, calibrators, and waste liquid are potentially bioinfectious. Maintenance personnel should
observe the laboratory safety operation regulations and wear personal protective equipment (such as
laboratory protective clothing and gloves) when contacting with and handling relevant items in the
laboratory.
Warning
 Unpacking or installation by unauthorized or untrained personnel may cause personal injury or damage to the
analyzer. Therefore, do not unpack or install the analyzer without the presence of authorized personnel from
YHLO.
 Please read this Guide carefully before installation and perform installation steps sequentially.
Note
 Do not use the Installation Guide if any pages are missing. In this case, contact YHLO for a new copy.
Table of Contents
Chapter 1 Preparations ........................................................................................................................................1
1.1 Purpose ..................................................................................................................................................... 1
1.2 Installation Procedure ............................................................................................................................... 1
1.3 Tools and Accessories .............................................................................................................................. 2
Chapter 2 Installation Requirements .................................................................................................................. 3
2.1 Working Environment .............................................................................................................................. 3
2.2 Unpacking Space ...................................................................................................................................... 3
2.3 Installation Space ......................................................................................................................................3
2.4 Power Supply and Noise ...........................................................................................................................4
2.5 Drainage Requirements ............................................................................................................................ 5
Chapter 3 Unpacking .......................................................................................................................................... 6
3.1 Inspection Before Unpacking ................................................................................................................... 6
3.1.1 Configuration Check ..........................................................................................................................6
3.1.2 Packing inspection .............................................................................................................................6
3.2 Unpack the Analyzer ................................................................................................................................ 6
3.3 Unpack the Accessories ............................................................................................................................8
3.4 Check Against the Packing List ................................................................................................................9
Chapter 4 Removal of Protective and Fixing Items ......................................................................................... 11
4.1 Remove the Protective Cover ................................................................................................................. 11
4.2 Remove Protective and Fixing Items of the Analyzer ............................................................................12
4.2.1 Remove Protective Tapes ................................................................................................................ 12
4.2.2 Remove Fixing Items of the Panel .................................................................................................. 12
4.3 Inspection and Verification .................................................................................................................... 14
4.3.1 Check the Connectors of the Liquid System ................................................................................... 14
4.3.2 Check and Clean the Wash Buffer Tank A ..................................................................................... 15
4.3.3 Check the Anti-static Brush .............................................................................................................16
Chapter 5 Installation and Connection ............................................................................................................. 17
5.1 Fix the Instrument ...................................................................................................................................17
5.2 Tube Connection, Solution Loading and Waste Bucket Fixing ............................................................. 17
5.3 Install the PC .......................................................................................................................................... 20
5.4 Connect the Handheld Barcode Scanner ................................................................................................ 20
5.5 Connect the Power Supply ..................................................................................................................... 20
Chapter 6 Software Installation and PC Settings ..............................................................................................21
6.1 Upper-layer Unit Software Installation .................................................................................................. 21
6.1.1 Requirement of Computer Configuration ........................................................................................21
6.1.2 iFlash Software Installation ............................................................................................................. 21
6.2 Set up the PC .......................................................................................................................................... 22
6.2.1 Cancel the sleep mode ..................................................................................................................... 22
6.2.2 Disable the Firewall .........................................................................................................................23
Chapter 7 Power On ......................................................................................................................................... 26
7.1 Startup Preparations ................................................................................................................................26
7.2 Initial Startup .......................................................................................................................................... 26
7.3 Boot Check & Position Confirm ............................................................................................................ 28
7.3.1 Check the Instrument Information ...................................................................................................28
7.3.2 Parameter Export and Backup ......................................................................................................... 28
7.3.3 Temperature Confirm ...................................................................................................................... 29
7.3.4 Mechanical Position Confirm ..........................................................................................................30
7.4 Liquid System Priming and Performance Check ................................................................................... 42
7.4.1 Load Pre-trigger and Trigger Solution in Software .........................................................................42
7.4.2 Liquid System Priming ....................................................................................................................42
7.4.3 Magnetic Separation Dispensing and Aspiration Performance Check ............................................42
7.4.4 Pre-trigger Dispensing Performance Check .................................................................................... 45
7.4.5 Trigger Dispensing Performance Check ..........................................................................................46
7.5 Settings ................................................................................................................................................... 47
7.5.1 Instrument Settings .......................................................................................................................... 47
7.5.2 Print Settings ....................................................................................................................................48
7.5.3 Assay Settings ..................................................................................................................................49
7.5.4 Reagent Loading ..............................................................................................................................50
Chapter 8 Performance Verification .................................................................................................................51
8.1 Dark Count Test ......................................................................................................................................51

8.2 Pre-trigger & Trigger Background Test ................................................................................................. 52
8.3 Water Test ...............................................................................................................................................52
8.4 FSH Background Test ............................................................................................................................ 56
8.5 FSH RLU Reading Repeatability Test ................................................................................................... 56
8.6 Database Backup .................................................................................................................................... 56
8.7 Installation Checklist .............................................................................................................................. 57
Chapter 9 Importer Information Label (EU Region Only) & Installation Report Form .................................. 61
9.1 Importer Information Label (EU Region Only) ..................................................................................... 61
9.2 Installation Report Form Fill In ..............................................................................................................62
Chapter 1 Preparations
1.1 Purpose
This Installation Guide describes the steps for smooth installation and subsequent software upgrade on the
client side to ensure safe and effective operation of the device.
1.2 Installation Procedure
Pic 1-1 Installation procedure
YHLO/AF-12-iF10-001/A0 1
1.3 Tools and Accessories

Table 1-1 List of Tools and Accessories
Name Quantity
Adjustable wrench 2
Internal hexagonal socket wrench 1 (set)
Phillips screwdriver 1
Slotted screwdriver 1
Scissors or cutting pliers 1
Mechanical debugging fixture 1 (set)
Pipette 1
Gloves 2
USB flash disk 1
Paper towel 1
2 YHLO/AF-12-iF10-001/A0
Chapter 2 Installation Requirements
2.1 Working Environment

 Altitude: ≤ 4000 m;
 For indoor use only;
 The bearing table (or ground) should be level (gradient < 1/200) and is able to bear at least 150kg of weight;
 The bearing table (or ground) should be free of vibrations;
 The workplace should be well ventilated and dust-free;
 Keep the analyzer away from direct sunlight, heat, strong wind, and corrosive and flammable gas;
 Ambient temperature between 10oC~30oC, with fluctuation ≤ 2oC/h. equip AC if necessary;
 Ambient humidity between 20% RH ~ 85% RH, without condensation.
*Precautions:
 Data reliability cannot be guaranteed if the above working conditions are not met;
 During operation, the instrument generates heat and dissipate it through the rear of the instrument. The
working environment should be well ventilated to ensure heat dissipation;
 Use ventilation equipment, but avoid direct airflow to the instrument; otherwise data reliability may be
compromised.
2.2 Unpacking Space

 Dimension with package: 1140 mm L × 850 mm W × 860 mm H;
 Unpacking space requirement: Width>1.5m, Length>2m.
2.3 Installation Space

 Dimension without package: 930 mm L × 710 mm W × 650 mm H;
 Instrument weight: 120 kg;
 Installation space requirement: Recommended length >2100mm, width >1400mm, maintenance space around
the analyzer > 650mm;
 If the space is insufficient, it is recommended to use a movable table, and a heat dissipation space of 100 mm
to be reserved behind the instrument.
YHLO/AF-12-iF10-001/A0 3
Pic 2-1 Installation space
2.4 Power Supply and Noise

 220V Model: 200-240V~50/60 Hz; Voltage fluctuation: ±10%; Line frequency: ±1 Hz;
 110V Model: 100-120V~50/60 Hz; Voltage fluctuation: ±10%; Line frequency: ±1 Hz;
 Three-core power cord, properly grounded.
Warning:
Power supply should be properly grounded. Improper grounding may lead to electric shock and system damage.
Check that the output voltage of the power socket meets the requirements of the system and a suitable fuse has been
installed.
 Rated input power of the analyzer: 600VA. The power socket connected to the instrument shall have a
bearing capacity of no less than 10A (or 20A for 110V model);
 If a UPS is installed to power the instrument, the UPS capacity must be greater than or equal to 1000 VA (for
the analyzer + computer + printer);
 The installation site should be kept away from large noise and power supply interference;
 Keep the instrument away from brush-type engines and electrical contact equipment that is frequently
switched on and off;
 Keep the instrument away from devices that emit electromagnetic waves, such as mobile phones and
transceivers.
4 YHLO/AF-12-iF10-001/A0
2.5 Drainage Requirements

 The waste liquid from the analyzer could drain directly into the sewer, the waste tube should be no longer
than 5m;
 Sewer port should have a diameter no less than 50mm;
 If we use waste liquid tank to drain waste liquid from the analyzer, the tube connecting to the waste tank
must not emerge into the liquid and the tube cannot exceed the cap for more than 35mm;
 The sewer port or waste liquid tank cannot be higher than the bearing table, make sure the tubes aren’t bent,
raised, or folded in anyway;
 The condensation water from the analyzer can only be drained into the waste liquid tank.
Biological Infection Risks:

Dispose of waste liquid from the system according to local discharge standards.
YHLO/AF-12-iF10-001/A0 5
Chapter 3 Unpacking
Warning:
Unpacking or installation by unauthorized or untrained personnel may cause damage to the analyzer. Therefore, do not
unpack or install the analyzer without the presence of authorized personnel from YHLO.
3.1 Inspection Before Unpacking

3.1.1 Configuration Check
Check the configuration against the packing list before unpacking. The configuration list is as follows.
Table 3-1 Configuration List

Name Quantity
Large case (box) 1
Accessory case 1 (box 1) 1
Accessory case 2 (box 2) 1
Computer case 1
3.1.2 Packing inspection

Check that the fixing bags of each packing case and the fixing screws of the analyzer packing case are still
firm, and the outer packaging is well protected without damage. If the packaging has been damaged, take photos
as evidence, or confirm with the agent and logistics company to ensure that the equipment is intact before
installing.
3.2 Unpack the Analyzer

1. Use diagonal pliers to cut the packing straps (be careful not to scratch your hands due to the sudden release
of the tight straps). Then, remove the upper cover and the surrounding outer packing.
Pic 3-1 Unpack the analyzer
6 YHLO/AF-12-iF10-001/A0
Pic 3-2 Unpack the analyzer
2. Check whether the appearance of the analyzer is intact.

3. Remove the screws on four angle brackets.
4. If the user does not have special requirements such as height requirements, there is no need to adjust the
anchors, which have already been leveled before delivery. You only need to check that the four anchors are
level and adjust them to the locking state as shown in Pic 3-4.
Pic 3-3 Remove the angle brackets
YHLO/AF-12-iF10-001/A0 7
Pic 3-4 Check the anchors
3.3 Unpack the Accessories

1. Open the accessory boxes, check whether each accessory is intact, and check against the packing list.
Pic 3-5 Unpack the accessories
2. Take out the instrument carrying handles and tighten the four handles, as shown in the Pic below.
8 YHLO/AF-12-iF10-001/A0
Pic 3-6 Tighten the handles
3. Lift the instrument to the table top, and ensure that the table top is level.
Note:
The instrument is heavy. Ensure that handles are firmly tightened. Pay attention to personal safety, and wear gloves
when handling the instrument.
3.4 Check Against the Packing List

Check the packing list in the packing case and verify that the content in the packing case matches the packing list.
Note:
If the content of the packing case does not match the packing list, immediately inform the after-sales service department
or the local agent of YHLO.
iFlash 1200 Packing List (V1.0)

Large case (box)
No. Name Specifications or Model Quantity
Automatic Chemiluminescence
1 iFlash 1200 1
Immunoassay Analyzer
2 Warranty card / 1
3 Certificate of quality / 1
4 Installation report In triplicate 1
Accessory case 1 (box 1)
1 iFlash 1200 user manual (English) English 1
2 iFlash 1200 user operation card English 1
3 Installation training record for customer / 1
4 Barcode scanner / 1
YHLO/AF-12-iF10-001/A0 9
5 Sample rack 16-well 1

6 5 m network cable LAN standard network cable 1
7 Power cord GB standard 10 A 1
8 Disposable waste vessel container / 5
9 Reaction vessel English 1000 pcs
10 Carrying handle / 4
11 Hose (4106, 1/4 x 3/8, RNT) 3M 1
12 Hose (3.2 x 6.4 mm, ND-100-65) 10M 1
13 Float switch Cleaning tank 1
Single-hole cover for 10 L tank (with
14 / 1
opening)
15 Float switch Waste tank 1
Round-bottom centrifugal tube with
16 5 mL 30
buckle
17 5 m cross serial cable / 2
18 Red external Luer connector Red 1
19 Green external Luer connector Green 1
20 Key to the flip-open cover / 2
21 Rubber side cover White 4
22 Kit assembly With the magnetic beads cavity 2
Accessory case 2 （box 2)
1 10 L tank Double-hole waste tank 1
2 Outer cover / 1
3 Cover opening / 1
Computer case
1 PC monitor Desktop LED monitor 1
PC host (including the keyboard, mouse,
2 / 1
and mouse pad)
10 YHLO/AF-12-iF10-001/A0
Chapter 4 Removal of Protective and Fixing Items

4.1 Remove the Protective Cover
Remove the moisture-proof bag of the analyzer, and make sure that the instrument is free of scratches or
dents.
Pic 4-1 Remove the moisture-proof bag
YHLO/AF-12-iF10-001/A0 11
4.2 Remove Protective and Fixing Items of the Analyzer

4.2.1 Remove Protective Tapes
Remove the protective items from the front doors and covers of the analyzer, such as the sample cavity door,
front door cover, and top cover of the RV feeder.
Pic 4-2 Remove the protective tapes
4.2.2 Remove Fixing Items of the Panel

Open the cover of the analyzer, remove the binding straps and foam that fix the 3D mechanical arm assembly,
probe assembly and magnetic separation aspiration probe, as well as the fiber tapes that fix the reagent carousel
cover.
Pic 4-3 Remove fixing items
12 YHLO/AF-12-iF10-001/A0
Pic 4-4 Remove fixing items of the probe assembly
Pic 4-5 Remove fixing items of the MS aspiration probe
YHLO/AF-12-iF10-001/A0 13
Pic 4-6 Remove fixing items of the 3D mechanical arm
4.3 Inspection and Verification

4.3.1 Check the Connectors of the Liquid System
1. Check the connectors of all the components of the liquid module. If problems such as crystallization or
leakage are detected, check whether the connectors are loose.
2. If any connectors are loose, tighten the connectors and check for pipeline leakages during subsequent
priming.
3. If the connectors are not loose, check whether there is any foreign object or any flanging defects. If yes,
contact YHLO technical support. If necessary, replace the defected connector and liquid system components.
4. After inspection, double-check the connectors during subsequent priming of the liquid system before putting
back the housing.
14 YHLO/AF-12-iF10-001/A0
Pic 4-7 Pump & valve connectors
4.3.2 Check and Clean the Wash Buffer Tank A

1. Remove the right panel of the instrument, and check whether there is any damage to the inner tank.
2. Remove the bottle cover assembly, and rinse the tank with pure water or deionized water for three times.
Restore the bottle cover assembly after cleaning.
Pic 4-8 Check wash buffer tank A
YHLO/AF-12-iF10-001/A0 15
4.3.3 Check the Anti-static Brush

1. Put couple sample tubes on the sample rack.
2. Manually pull the sample rack back and forth on the trolley to check whether the anti-static brush can brush
the sample tubes properly.
3. See the Pic below.
Pic 4-9 Check the anti-static brush
16 YHLO/AF-12-iF10-001/A0
Chapter 5 Installation and Connection

5.1 Fix the Instrument
1. Double-check the levelness and stability of the table top.
Pic 5-1 Fix the instrument
Note: After the instrument is properly placed, remove the four carrying handles and place them in the accessory
packing and properly keep them for future use.
5.2 Tube Connection, Solution Loading and Waste Bucket Fixing

1. Cut the soft tubes in the accessory box to a decent length, connect the tubes for wash buffer outer tank, waste
liquid tank and reagent carousel condensation water outlet port (make sure they are connected to the correct
tank and port, waste liquid and condensation water tubes go into the waste liquid tank). Connect the 2 floater
sensors (make sure they are connected to the correct tank and connectors!).
YHLO/AF-12-iF10-001/A0 17
Pic 5-2 Connect external pipes
2. Load washing solution in the wash buffer outer tank --> find the concentrate wash buffer 10x bottle in the
accessory box, pour the whole bottle into the wash buffer outer tank. Add de-ionized, distilled or purified
water to the wash buffer tank, add to halfway of the tank, shake the tank a little, and then add all the way to
the 10L marker line on the tank.
Pic 5-3 Load the wash buffer
3. Open the door of the trigger/pre-trigger loading cabinet, load the pre-trigger and trigger solution, and connect
the pipes. Ensure that the bottle cover assemblies of the pre-trigger and trigger are not in contact with
contaminants.
18 YHLO/AF-12-iF10-001/A0
Pic 5-4 Load the pre-trigger and trigger
4. Connect the waste drainage pipe:

 If the waste liquid is directly discharged into the sewer, cut an appropriate length of the drainage pipe as
needed and connect it to the waste discharge outlet.
 If a waste tank is used, insert the pipe into the opening of the waste tank.
Note:
1 The end of the waste drainage pipe shall not be immersed in the waste liquid. When the waste is discharged
into a waste tank, the drainage pipe shall extend into the tank no more than 35 mm. Otherwise, a large
number of bubbles may be formed due to the air flow in the drainage pipe, resulting in water overflow or
other problems.
2 The condensate drainage pipe must be connected to the waste tank.
3 The drainage pipe should not be too long. Keep the horizontal downward direction of the water flow, no
U-shaped bending should exist on the pipe, and no part of the drainage pipe should be higher than the
drainage outlet of the instrument.
YHLO/AF-12-iF10-001/A0 19
Pic 5-5 Connect the waste drainage pipe
5.3 Install the PC

1. Install the PC and monitor.
2. Connect the COM cable between the analyzer and the computer.
5.4 Connect the Handheld Barcode Scanner

Connect the 2D barcode scanner to the USB port of the PC.
5.5 Connect the Power Supply

Connect the instrument, PC, monitor, printer to their specified power supply firmly.
20 YHLO/AF-12-iF10-001/A0
Chapter 6 Software Installation and PC Settings

6.1 Upper-layer Unit Software Installation
6.1.1 Requirement of Computer Configuration
Parameter Description
CPU 3.6GHz, dual core
Mainboard BIOS supports remote start up via Internet
Hard disk 500GB STAT interface
Memory 4GB
Operating system Windows 7 / Windows 10 64bit O/S
USB port 2 or more
Serial port 1 (COM1 is must)
Monitor 19” or above, touch screen (optional) with a resolution no less than 1440*900
6.1.2 iFlash Software Installation

Double click the software installer “Setup-iFlash”; Select Instrument Amount 1; Select Instrument model
iFlash 1200; Make sure that the software is installed in D drive, click next until the installation is complete.
Pic 6-1 Select model as iFlash 1200
YHLO/AF-12-iF10-001/A0 21
6.2 Set up the PC

6.2.1 Cancel the sleep mode
1. Go to Control Panel > Hardware and Sound.
Pic 6-2 Control panel
2. Click “Change battery settings” in Power Options.
Pic 6-3 Power options
22 YHLO/AF-12-iF10-001/A0
Pic 6-4 Change battery sleeptime
3. Select Never to disable the computer sleep time.
6.2.2 Disable the Firewall

1. Go to Control Panel > System and Security.
Pic 6-5 System and Security
2. Click Windows Defender Firewall.
YHLO/AF-12-iF10-001/A0 23
Pic 6-6 Windows Defender Firewall
3. Select Turn off Windows Firewall for both “Private network settings” and “Public network settings”.
Pic 6-7 Disable the Firewall
4. In step 3, choose Advanced Settings > Windows Firewall Properties.
24 YHLO/AF-12-iF10-001/A0
Pic 6-8 Firewall properties
5. As shown in the Pic below, set the firewall state to Off for “Domain Profile”, “Private Profile”, and “Public
Profile” tabs.
Pic 6-9 Firewall property configuration
YHLO/AF-12-iF10-001/A0 25
Chapter 7 Power On
7.1 Startup Preparations
Open the RV feeder cover, and load reaction vessels into the RV feeder (the RV feeder could hold up to 500
reaction vessels at a time).
Pic 7-1 Load the reaction vessels
7.2 Initial Startup

1. Turn on the main switch of the analyzer.
Pic 7-2 Switch
26 YHLO/AF-12-iF10-001/A0
2. Turn on the PC, and launch the iFlash app.
Pic 7-3 iFlash app
3. After the startup animation, the "Initialization or not?" window is displayed. Click No (the default option is
Yes). After the 10 seconds countdown, the system will automatically start to perform initialization, but in this
step, select No.
Pic 7-4 Startup initialization
4. Login window is displayed as shown below. Login to the system using the service engineer account (user
name: serviceuser, password: updated quarterly).
Pic 7-5 Login to the system
YHLO/AF-12-iF10-001/A0 27
7.3 Boot Check & Position Confirm

7.3.1 Check the Instrument Information
Enter Utility > System settings > Device version info, Click Query. Check if the instrument version
information is correct.
Pic 7-6 Device version information
7.3.2 Parameter Export and Backup

Enter Utility > Service > STR/MC > Param query/conf, Click Query and then Export for both STR and
MC to save the corresponding parameters of CAR, MD1, MD2 and MD3. After clicking Export, a pop up
window will show and tell you where to find the parameters. Please go to the corresponding folders to copy the
parameter file (MD1.ini, MD2.ini... etc.) to the desktop or to a USB drive.
Pic 7-7 Export parameters
28 YHLO/AF-12-iF10-001/A0
Pic 7-8 Export parameters
7.3.3 Temperature Confirm

After startup for 15~30 minutes, click Temperature tab, check whether the temperature of each system is
displayed normally and within range.
Pic 7-9 Temperature confirm
YHLO/AF-12-iF10-001/A0 29
7.3.4 Mechanical Position Confirm

To check the position, open the door cover of the instrument using the key, and remove the reagent carousel
cover.
Pic 7-10 Position confirm
7.3.4.1 Gripper to RV Carousel Position Confirm

1. Enter Utility > Service > MC > Confirm hardware status > Motor position confirm, click Sample probe
reset gripper reset. After the reset is completed, set Gripper horizontally moves to RV carousel, and click
Movement. After the movement is finished, click Gripper holding and put the gripper fixture tool into the
gripper finger, and click Vertical disable.
Pic 7-11 Gripper to RV carousel position confirm
30 YHLO/AF-12-iF10-001/A0
2. Click RV carousel reset and wait for the reset to finish, put the RV carousel fixture tool into the RV carousel,
manually press the gripper down, confirm that the gripper fixture is aligned with the hole of the RV carousel
fixture.
Pic 7-12 Gripper to RV carousel position confirm
3. After confirmation, remove all the fixture tools.
7.3.4.2 Gripper to Vessel Gripping Position in Magnetic Separation Position Confirm

1. Click Sample probe reset gripper reset. After the reset is completed, Set Gripper horizontally moves to
Vessel gripping position in magnetic separation, and click Movement. After the movement is finished,
click gripper holding and put the gripper fixture tool into the gripper finger, and click Vertical disable.
Pic 7-13 Gripper to vessel gripping position in magnetic separation position confirm
YHLO/AF-12-iF10-001/A0 31
2. Click Magnetic separation reset, and set Magnetic Separation 1 hole moves to Vessel gripping position in
magnetic separation, and then click Movement.
3. Put the incubator fixture tool into the magnetic separation carousel, manually press the gripper down,
confirm that the gripper fixture is aligned with the incubator fixture.
32 YHLO/AF-12-iF10-001/A0
7.3.4.3 Gripper to Dilution Position Position Confirm

1. Click Sample probe reset gripper reset and wait for the reset to finish, set Gripper horizontally moves to
Dilution position, and click Movement. After the movement is finished, click Gripper holding and put the
gripper fixture tool into the gripper finger, then click Vertical disable.
2. Put the incubator fixture tool into the dilution position, manually press the gripper down, confirm that the
gripper fixture is aligned with the incubator fixture.
Pic 7-16 Gripper to dilution position position confirm
YHLO/AF-12-iF10-001/A0 33
7.3.4.4 Gripper to Sampling Position Position Confirm

Sampling position, and click Movement. After the movement is finished, click Gripper holding and put the
gripper finger fixture tool into the gripper finger, and click Vertical disable.
2. Put the incubator fixture tool into the sampling position, manually press the gripper down, confirm that the
gripper fixture is aligned with the incubator fixture (Sampling position is next to dilution position).
Pic 7-17 Gripper to sampling position position confirm
34 YHLO/AF-12-iF10-001/A0
7.3.4.5 Gripper to Mixing Position Position Confirm

1. Click Sample probe reset gripper reset and wait for the reset to finish, then set Gripper horizontally moves
to to Mixing Position, and click Movement. After the movement is finished, click Gripper holding and put
the gripper fixture tool into the gripper finger, and click Vertical disable.
2. Click Mixer reset, put the incubator fixture tool into the mixing position, manually press the gripper down,
confirm that the gripper fixture is aligned with the incubator fixture.
Pic 7-18 Gripper to mixing position position confirm
YHLO/AF-12-iF10-001/A0 35
7.3.4.6 Gripper to Reading Station Position Confirm

PMT reading station, and click Movement. After the movement is finished, click Gripper holding and put
2. Click PMT reading station reset, and after the reset is finished, set PMT reading station cart move to Vessel
gripping position, and click Movement.
3. Put the PMT reading station fixture tool into the PMT reading station cart (vessel carrier), manually press the
gripper down, confirm that the gripper fixture is aligned with the PMT reading station fixture.
Pic 7-19 Gripper to reading station position confirm
36 YHLO/AF-12-iF10-001/A0
7.3.4.7 Gripper to Waste Box Position Confirm

to Waste box, and click Movement. After the movement is finished, click Vertical disable.
2. Manually press the gripper down, and visually confirm that the gripper is aligned with the center of the
vessel discarding position.
Pic 7-20 Gripper to waste box position confirm
YHLO/AF-12-iF10-001/A0 37
7.3.4.8 Gripper to Incubator Position Confirm

to Incubator hole 1, and click Movement. After the movement is finished, click Gripper holding and put
2. Put the incubator fixture tool into incubator hole 1, manually press the gripper down, confirm that the gripper
fixture is aligned with the the incubator fixture.
Pic 7-21 Incubator positions
3. Use the same method to check the positions of incubator hole 8, 41, and 48.
38 YHLO/AF-12-iF10-001/A0
7.3.4.9 Sample Probe to Dilution Position Position Confirm

1. Click Sample probe reset gripper reset and wait for the reset to finish. Set sample probe horizontally
moves to Dilution position, and click Movement. After the movement is finished, click Vertical disable.
2. Put the incubator fixture tool into the dilution position, manually press the sample probe down, confirm that
the sample probe is aligned with the the incubator fixture tool.
Pic 7-22 Sample probe to dilution position position confirm
YHLO/AF-12-iF10-001/A0 39
7.3.4.10 Sample Probe to Sampling Position Position Confirm

moves to Sampling position, and click Movement. After the movement is finished, click Vertical disable.
2. Put the incubator fixture tool into the sampling position, manually press the sample probe down, confirm that
the sample probe is aligned with the the incubator fixture tool.
7.3.4.11 Sample Probe to Sample Rack Position Confirm

moves to Odd-number position of sample rack, and click Movement. After the movement is finished,
click Vertical disable.
2. Click Car reset, after the reset is completed, select Sample rack hole 1 moves to Sample rack loading
position, and click Movement, sample rack hole 1 will move to the sample aspiration position.
3. Manually press the sample probe down, visually confirm that the sample probe is aligned with the center of
the sample rack hole 1.
Pic 7-23 Sample probe to sample rack position confirm
4. Use the same method to confirm the positions of the Even-number position of sample rack (Choose
sample rack hole 2).
40 YHLO/AF-12-iF10-001/A0
7.3.4.12 Sample Probe to Washing Station Position Confirm

1. Click Sample probe reset gripper set and wait for the reset to finish. Set sample probe horizontally moves
to Washing station, and click Movement. After the movement is finished, click Vertical disable.
2. Put the washing station fixture tool into the washing station, manually press the sample probe down, confirm
that the sample probe is aligned with the washing station fixture tool.
Pic 7-24 Sample probe to washing station position confirm
7.3.4.13 Sample Probe to Reagent Carousel Position Confirm

moves to 1st circle of reagent carousel, and click Movement. After the movement is finished, click Vertical
disable.
2. Click Reagent carousel reset. After the reset is completed, select Slot No. 6 and 1st circle Rotate to
aspiration position and click Movement. Slot No.6 1st circle will move to aspiration position.
3. Put the reagent carousel fixture tool into slot No. 6 of the reagent carousel (No.6 is the only position that
could hold the reagent carousel fixture tool).
4. Manually press the sample probe down, confirm that the sample probe is aligned with the hole of the reagent
carousel fixture.
5. Use the same method to check the alignment of 2nd, 3rd and 4th circle of the reagent carousel.
YHLO/AF-12-iF10-001/A0 41
7.4 Liquid System Priming and Performance Check

7.4.1 Load Pre-trigger and Trigger Solution in Software
1. Click Reagent page in the software, find Pre-Trigger and Trigger icon, click on Pre-Trigger first, and then
click “Pre/Trigger Load”; In the pop up window, click into the “Bar code” box, and then use the external bar
code scanner to scan the bar code on the pre-trigger bottle; Click save. Do the same for trigger solution.
7.4.2 Liquid System Priming

1. Initialize the analyzer and wait for the status to come to stand-by. Enter Utility > Maintenance >
Maintenance instructions. Select Prime, perform priming for magnetic separation, pre-trigger, trigger, and
sample probe as instructed.
Pic 7-30 Liquid system priming
2. Observe the state of all liquid paths during priming to see if the priming process is smooth and there are not
too many bubbles in the liquid paths.
3. Prime the instrument twice on installation.
7.4.3 Magnetic Separation Dispensing and Aspiration Performance Check

1. Put 5 reaction vessels into 1-5th position of the incubator.
2. Enter Utility > Service > MC > Basic performance > HT2. Select Dispensing phase 2, and set Test times
to 5.
3. Click Reset, after the reset is completed, click Start. The instrument automatically starts adding wash buffer
as phase 2 magnetic separation.
42 YHLO/AF-12-iF10-001/A0
Pic 7-31 Magnetic separation dispensing performance check
4. Use pipette to add 600 μL of pure water to another reaction vessel. Compare the liquid volume in the reaction
vessel (pure water) with those in the 5 reaction vessels on the incubator, check whether the dispensing
volume is accurate (if all 6 vessels are of same liquid level), and whether there are any bubbles in the 5
reaction vessels.
Normal Abnormal
Pic 7-32 Magnetic separation dispensing performance check
5. Again, put 5 new reaction vessels into 1-5th position on the incubator, select Dispensing phase 2 and
Aspiration, and repeat step 3. Then, observe whether the liquid in the reaction vessel is being completely
aspirated (no liquid left in all 5 vessels) to check the magnetic separation aspiration performance.
YHLO/AF-12-iF10-001/A0 43
Pic 7-33 D2 aspiration performance check
6. Repeat steps 2, 3, 4 and 5, and check the performance of D3 dispensing and aspiration.
*Note: D2 dispensing volume is 600 μL, D3 dispensing volume is 690 μL, and D4 dispensing volume is 710 μL.
44 YHLO/AF-12-iF10-001/A0
7.4.4 Pre-trigger Dispensing Performance Check

1. Put 5 reaction vessels into 1-5th position of the incubator.
2. Enter Utility > Service > MC > Basic performance > HT3, set Pre-trigger as 100, Trigger as 0, and Test
times to 5.
3. Click Reset, after the reset is completed, click Start.
Pic 7-34 Pre-trigger dispensing check
4. Use pipette to add 100 μL of pure water to another reaction vessel. Compare the liquid volume in the reaction
vessel with those in the 5 reaction vessels on the incubator, check whether the dispensing volume is accurate,
and check the appearance of liquid in the reaction vessels (should have no or very less bubbles).
Pic 7-35 Pre-trigger dispensing check
YHLO/AF-12-iF10-001/A0 45
7.4.5 Trigger Dispensing Performance Check

1. Put 5 reaction vessels into 1-5th position on the incubator.
2. Enter Utility > Service > MC > Basic performance > HT3, set Pre-trigger as 100, Trigger as 200, and
Test times to 5, select Reading and Mixing.
3. Click Reset. After the reset is completed, click Start.
Pic 7-36 Trigger dispensing check
4. Use a pipette to add 300 μL of pure water to another reaction vessel. Compare the liquid volume in the
reaction vessel with those in the 5 reaction vessels on the incubator, check whether the dispensing volume is
accurate, and check the appearance of liquid in the reaction vessels (should have no or very less bubbles).
Pic 7-37 Trigger dispensing check
46 YHLO/AF-12-iF10-001/A0
7.5 Settings
7.5.1 Instrument Settings
1. Enter Utility > System settings > Instrument settings > Factory settings to enter the Factory settings
page, as shown in the below picture.
Pic 7-38 Factory settings
YHLO/AF-12-iF10-001/A0 47
2. Check the box Auto reagent load.

3. If waste liquid is discharged into the waste tank, check the box Waste sensor enabled, if not, don’t check the
box.
4. If you use soft caps on reagent kits, don’t check the box Reagent level detection on, if not, check the box.
5. Don’t check the box Clot detection on.
6. Click Save after the settings are done.
7.5.2 Print Settings

Enter Utility > System settings > Print to enter the Print settings page. Set the relevant print parameters as
needed, as shown in the picture below.
Pic 7-39 Print settings
48 YHLO/AF-12-iF10-001/A0
7.5.3 Assay Settings

1. Enter Utility > Assay settings, as shown in the picture below.
Pic 7-40 Assay settings
2. Click Add to add new methodology, as shown in the picture below. Use the external barcode scanner to
scan the methodology QR code to add methodology.
Pic 7-41 Add new methodology
YHLO/AF-12-iF10-001/A0 49
7.5.4 Reagent Loading

1. Remove the reagent hard cap and replace them with the soft cap that comes in the reagent kit box, ensure that
there are no bubbles in the reagent kit. If there are bubbles, use a pipette to remove the bubbles.
2. Open the reagent carousel cover, load the reagent into the reagent carousel properly, and close the reagent
carousel cover.
3. After the reagent loading process is completed, enter the Reagent page, and check the Carousel or List tab
to see whether the reagent has been successfully loaded.
Pic 7-42 Reagent loading
50 YHLO/AF-12-iF10-001/A0
Chapter 8 Performance Verification

8.1 Dark Count Test
1. Enter Utility > Service > MC > Basic performance > HT3. Click Open PMT to set PMT to open state,
wait 10 seconds. Click Reading every 30 seconds, repeat 10 times, instrument will read and record dark
count data, and results will show in the result box.
Pic 8-1 Dark count test
2. Check whether all results are within range (RLU ≤ 250).
YHLO/AF-12-iF10-001/A0 51
8.2 Pre-trigger & Trigger Background Test

1. Put 10 reaction vessels into 1~10th position on the incubator.
2. In HT3 page, set Pre-trigger as 100, Trigger as 200, Test Times as 10, check the box Reading and Mixing,
click Reset, after the Reset is completed, click Start.
3. Test results will show in the result box and check whether all results are within range (RLU ≤ 350).
Pic 8-2 Pre-trigger/trigger background test
8.3 Water Test

1. Add water test methodology. Enter Utility > Assay settings > Assay, click add and scan below QR code, the
Assay ID for water test is 800. (For 03 or previous version software of iFlash 1200, yhlo account is
needed for water test)
Water Test Methodology QR Code
52 YHLO/AF-12-iF10-001/A0
Pic 8-3 Water test methodology
2. Add pure water to a blank reagent bottle (fill all 4 chambers, #1~#4 each fill with 4ml, 6.5ml, 6.5ml, and
3.5ml).
Pic 8-4 Empty reagent bottle
YHLO/AF-12-iF10-001/A0 53
3. Enter Reagent tab, manually choose a position for example reagent position 1 (click on position 1), then
click Manual Load. Input below barcode into the “Reagent Barcode” box and click save.
 Water Test Reagent Barcode (Any one of below barcode is applicable, if failed to add, please try with
another one):
4CYgg/ABCH 4CYgg9gBCH 4CYggzQBCH 4CYgg6IBCH

4CYggwgBCH 4CYggzgBCH 4CYgg7QBCH 4CYgg2IBCH
4CYgg4gBCH 4CYgg7gBCH 4CYgg3QBCH 4CYgg+IBCH
4CYgg0gBCH 4CYgg3gBCH 4CYgg/QBCH 4CYggxIBCH
4CYgg8gBCH 4CYgg/gBCH 4CYggwwBCH 4CYgg5IBCH
4CYggygBCH 4CYggwQBCH 4CYgg4wBCH 4CYgg1IBCH
Pic 8-5 Water test reagent manual load
4. Add 4mL of pure water in a 5mL disposable sample tube, and place the sample tube into any positions on the
sample rack, for example 1st position.
5. Enter Sample tab, input any sample ID, for example 1, select the position which you had put the sample tube
in, for example 1, select the water test.
6. Click on Options, double click on number of repetitions and set test times to 30 and save.
7. Click save.
8. Click the Play button to start the water test.
9. See in Result tab the result of water test, check if all RLU is within range (RLU ≤ 350).
54 YHLO/AF-12-iF10-001/A0
Pic 8-6 Water test applying
Pic 8-7 Water test applying
YHLO/AF-12-iF10-001/A0 55
8.4 FSH Background Test

1. Add 4mL pure water into a tube and test it as the sample. Run the FSH test for 10 times;
2. After tests, check if the reading is within range and export all the result.
3. RLU≤1000.
8.5 FSH RLU Reading Repeatability Test

1. Run FSH test for 10 times;
2. After test, check the luminous value and calculate the CV, check if it is within range;
3. CV≤5%.
8.6 Database Backup

1. After the verification is completed, back up the database.
2. The database file is in the installation path D:\iFlashDataBase
Pic 8-8 Database backup
56 YHLO/AF-12-iF10-001/A0
8.7 Installation Checklist

Assay
No. Description Reference Result
Inspection Item
1 Altitude Within the altitude range ≤ 4000 m □Pass □Fail
Within the operating
2 Ambient temperature 10oC to 30oC □Pass □Fail
temperature range
Working
Within the operating
3 environment Ambient humidity 20%RH to 85%RH □Pass □Fail
humidity range
Table top bearing capacity Bearing capacity ≥ 150 kg

4 Table top □Pass □Fail
and flatness Inclination < 1/200
The unpacking space meets Length > 2 m

5 Unpacking space □Pass □Fail
the requirements. Width > 1.5 m
The installation space meets Length > 2.1 m

6 Installation space □Pass □Fail
the requirements. Width > 1.4 m
Within the operating voltage
7 Power supply 220 V ± 10% □Pass □Fail
range
The neutral-line voltage
8 Neutral-line voltage <5V □Pass □Fail
meets the requirements.
The noise is within the
9 Noise Stay away from the interference. □Pass □Fail
range.
Waste pipe: Length < 5 m
Drainage related
10 Drainage Waste discharge outlet: Diameter ≥ 50 □Pass □Fail
environment
mm, height ≤ 0.35 m
Configuration list and Delivered content matches the
11 Configuration check □Pass □Fail
delivered content configuration list.
Analyzer outer package
12 Analyzer package Free of damage □Pass □Fail
inspection
Inspection
Accessory outer package
13 before Accessory package Free of damage □Pass □Fail
inspection
unpacking
PC host and PC host and monitor
14 Free of damage □Pass □Fail
monitor package Outer package inspection
Installation reagent Reagent outer package
15 Free of damage and leakage □Pass □Fail
package inspection
16 Packing list and delivered Delivered content matches the
Packing list verification □Pass □Fail
content packing list.
17 Motion inspection of the
Remove front protective items front door cover and other The door cover moves smoothly. □Pass □Fail
components
Remove fixing items of the probe Probe assembly motion The horizontal and vertical movement
18 □Pass □Fail
assembly inspection is smooth.
Remove fixing items of the magnetic Magnetic separation
19 The vertical movement is smooth. □Pass □Fail
separation assembly assembly motion inspection
Remove fixing items of the 3D 3D mechanical arm The assembly moves smoothly on the
20 □Pass □Fail
mechanical arm motion inspection X, Y, and Z axes.
Remove fixing items of the cap Appearance inspection of the

assembly cap assembly
Check the inner tank of cleaning Check whether the inner tank
solution is damaged.
23 Fixing of the analyzer Analyzer levelness Analyzer levelness □Pass □Fail
24 wash buffer connection Check the connection of The pipe is not bent. □Pass □Fail
YHLO/AF-12-iF10-001/A0 57
Assay
Inspection Item
wash buffer. Cap fastening
Pre-trigger and trigger The pipe is not bent.
25 Pre-trigger and trigger connection □Pass □Fail
Check the connection. Cap fastening
The pipe is not bent.
26 Waste connection Check the waste connection. □Pass □Fail
The connection is firm.
Check installation of the Installation of the disposable solid
27 Installation of the solid waste container □Pass □Fail
solid waste container. waste container
28 Connect the PC PC connection check The connection is correct and firm. □Pass □Fail
2D barcode scanner
29 Connection of the 2D barcode scanner The connection is correct and firm. □Pass □Fail
Check the connection.
30 Connect the power supply Power connection check The connection is correct and firm. □Pass □Fail
Software installation and The installation and connection are
31 Software installation □Pass □Fail
connection correct.
32 Startup preparations Startup preparations check The reaction vessel is loaded. □Pass □Fail
Instrument information
33 Check the instrument information The latest version is used. □Pass □Fail
check
Reagent carousel Check the reagent carousel
34 2oC to 8oC □Pass □Fail
temperature temperature.
Check the incubator
35 incubator temperature 37±0.3oC □Pass □Fail
temperature.
Temperature
Check the magnetic
check Magnetic separation
36 separation carousel 37±0.3oC □Pass □Fail
carousel temperature
temperature.
Magnetic separation Check the temperature of the
37 wash buffer magnetic separation wash 24oC to 30oC □Pass □Fail
temperature buffer.
Position of the gripper Confirming the position of
38 against the gripper against the RV Fixtures are center-aligned □Pass □Fail
RV carousel carousel.
Position of the gripper

against Check the position of the
39 gripper against the magnetic Fixtures are center-aligned □Pass □Fail
the magnetic separation separation carousel.
carousel
Position of the gripper Check the position of the
40 against the gripper against the dilution Fixtures are center-aligned □Pass □Fail
dilution position position.

41 Check the against the gripper against the sampling Fixtures are center-aligned □Pass □Fail
mechanical Sampling position position.
position.
42 against the gripper against the mixing Fixtures are center-aligned □Pass □Fail
Mixing position position.
Check the position of the

Position of the gripper gripper against incubator
43 Fixtures are center-aligned □Pass □Fail
against incubator hole 1
hole 1
Check the position of the
Position of the gripper gripper against incubator
against incubator hole 8
hole 8

against incubator hole gripper against incubator
58 YHLO/AF-12-iF10-001/A0
Assay
Inspection Item
41 hole 41

46 against incubator hole gripper against incubator Fixtures are center-aligned □Pass □Fail
48 hole 48
47 against the gripper against the PMT Fixtures are center-aligned □Pass □Fail
PMT reading station reading station

48 against the gripper against the vessel Visual inspection center □Pass □Fail
vessel discard position discard position.
Position of the sample Check the position of the

49 probe against the sample probe against the Fixtures are center-aligned □Pass □Fail
dilution position dilution position.

sampling position sampling position.

probe against the sample probe against the
sample rack aspirating
aspirating position position
washing tank washing tank

probe against the 1st sample probe against the
circle of reagent
carousel 1st circle of reagent carousel

probe against the 2nd sample probe against the
circle of reagent 2nd circle of reagent
carousel carousel.

probe against the 3rd sample probe against the
circle of reagent 3rd circle of reagent
carousel carousel.

probe against the 4th sample probe against the
circle of reagent 4th circle of reagent
carousel carousel.
Settings of the RV barcode
57 RV barcode scanner Check the settings. □Pass □Fail
scanner
Settings of the date and
58 Date and prompt tone Customer requirements □Pass □Fail
prompt tone
59 Print Print settings Customer requirements □Pass □Fail
60 User permissions User management settings Customer requirements □Pass □Fail
61 Maintenance Maintenance settings Customer requirements □Pass □Fail
62 Test assay Assay settings The assay is added. □Pass □Fail
63 Dark count Check the dark count results. RLU ≤ 200 □Pass □Fail
64 Performance Instrument noise Check the instrument noise. RLU ≤ 350 □Pass □Fail
validation
Check the pure water test
65 Pure water test RLU ≤ 350 □Pass □Fail
results.
YHLO/AF-12-iF10-001/A0 59
Assay
Inspection Item
Check the HBsAg
66 Background RLU ≤ 1000 □Pass □Fail
background.
67 RLU repeatability Check the RLU repeatability. CV ≤ 5% □Pass □Fail
68 Calibration Assay calibration The calibration is successful. □Pass □Fail
Check the calibration
69 Calibration verification High-value deviation ≤ 10% □Pass □Fail
verification result.
70 In-batch precision Check the in-batch precision. CV ≤ 8% □Pass □Fail
Check the HBsAg carry-over
71 Carry-over Carry-over rate (K)＜1×10-5 □Pass □Fail
rate.
72 Reliability Reliability verification The instrument runs properly. □Pass □Fail
73 Backup Back up parameters and the database. □Pass □Fail
60 YHLO/AF-12-iF10-001/A0
Chapter 9 Importer Information Label (EU Region Only)

& Installation Report Form
9.1 Importer Information Label (EU Region Only)
If the instrument is installed in the EU region, please paste the importer information label on the instrument
as instructed below. Please find the label in the accessory box.
Pic 9-1 Importer information label
Please paste the label on the surface of the instrument shell, pay attention to the position of the paste to avoid
affecting the normal operation of the instrument.
Pic 9-2 Paste of label
When uploading the instrument installation report as in chapter 9.2, for equipment in the EU region, please
make sure that the importer information label could be seen in the equipment picture uploaded in the form.
YHLO/AF-12-iF10-001/A0 61
9.2 Installation Report Form Fill In

Thank you very much for your long time trust and support to YHLO! And congratulations on the new
installation of the iFlash 1200 series analyzer.
In order for YHLO to best match your needs and to perfect our services, YHLO needs your kind cooperation
to fill some information for the new instrument you have installed. Please take a few minutes to finish an
Installation Report.
Please scan the below QR code or visit https://www.wenjuan.com/s/vmeuYnn/ to fill in the Installation
Report (you may use both mobile phone or computer to visit the link). Thank you very much for your
cooperation!
Installation Report QR code
62 YHLO/AF-12-iF10-001/A0

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iFlash 1200

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After-Sales Service Provider

Service hotline: 400-166-0755

About This Guide

Warning Read the instructions carefully. Improper operation

Caution Read the instructions carefully. Improper operation

Note Read the instructions carefully. Improper operation

For In vitro diagnostic medical device

Consult instructions for use

Relative humidity limit

Atmospheric pressure limit

Stacking limit by number

8.1 Dark Count Test ......................................................................................................................................51

1.2 Installation Procedure

Pic 1-1 Installation procedure

1.3 Tools and Accessories

Chapter 2 Installation Requirements

2.1 Working Environment

2.2 Unpacking Space

2.3 Installation Space

Pic 2-1 Installation space

2.4 Power Supply and Noise

2.5 Drainage Requirements

Biological Infection Risks:

3.1 Inspection Before Unpacking

Table 3-1 Configuration List

3.1.2 Packing inspection

3.2 Unpack the Analyzer

Pic 3-1 Unpack the analyzer

Pic 3-2 Unpack the analyzer

2. Check whether the appearance of the analyzer is intact.

Pic 3-3 Remove the angle brackets

Pic 3-4 Check the anchors

3.3 Unpack the Accessories

Pic 3-5 Unpack the accessories

Pic 3-6 Tighten the handles

3.4 Check Against the Packing List

iFlash 1200 Packing List (V1.0)

5 Sample rack 16-well 1

Chapter 4 Removal of Protective and Fixing Items

Pic 4-1 Remove the moisture-proof bag

4.2 Remove Protective and Fixing Items of the Analyzer

Pic 4-2 Remove the protective tapes

4.2.2 Remove Fixing Items of the Panel

Pic 4-3 Remove fixing items

Pic 4-4 Remove fixing items of the probe assembly

Pic 4-5 Remove fixing items of the MS aspiration probe

Pic 4-6 Remove fixing items of the 3D mechanical arm

4.3 Inspection and Verification

Pic 4-7 Pump & valve connectors

4.3.2 Check and Clean the Wash Buffer Tank A

Pic 4-8 Check wash buffer tank A

4.3.3 Check the Anti-static Brush

Pic 4-9 Check the anti-static brush