【要求仕様書】RT- (00000) -RSM-078 ver.1 - 試薬パック組立装置（K2） - 20230719

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Document Control #/Document control number B-FdAAA-17002-02 Ver.7
Document Control #:
Ver.1 Page: 1/70
Document control number: RT-(00000)-RSM-078
Equipment and Jig Requirements Specifications

(Main Performance/ Function) Equipment
and jig requirement specifications (main
performance/function)
Equipment (jig) name

Reagent pack assembly equipment (K2)
Equipment (jig) name
International Manufacturing & Engineering Services Co., Ltd. Imes Co.,

Ltd. Received by
Received by Received by
receipt receipt
/ / / / / /
ARKRAY Factory Inc.

ARKRAY Factory Inc.
Approved by Checked by Created by
Approved
Shigeru Kitamura Takashi Osumi Yuichi Nishimura
/ / / / /
/ Creation date Creating dept.
Creation date: 2023.07.11 Creation department: Equipment production technology team
Ver. Approval date Approved by Checked by Created by Revising dept.

Approval date Approved
ARKRAY Factory Inc.

Arkray Factory Co., Ltd.
Document Control#/Document Control Number B-FdAAA-17002-02 Ver.7
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Revision History Revision History
Approval date Revised section Revised content

Ver.
approval date Revised part Revision details
1 new N/A
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1. Purpose
the purpose
subject Production equipment installed at Arkray Factory Co., Ltd. (hereinafter referred to as our company)
Ordering side: Arkray Factory Co., Ltd. (hereinafter referred to as our company)
Consignment side: Equipment supplier who accepted this specification
fit Define the functions, performance, and specifications required for production equipment for products covered by this specification.
Stable product quality, equipment safety, maintainability, workability, reliability, and durability without exception
To secure and adapt.
Discussions Regarding matters not stated in this specification and delivery specifications, both companies will discuss.
However, both companies are responsible for any omissions that should have been made public based on their roles.
The corresponding range.
2. Scope
range
Requirements for the functions and performance required of production equipment for products covered by this specification.
Application details ÿ Detailed items other than those described in this specification are described in each equipment requirement specification (main equipment).
be.
RT-(00000)-RSM-004 v.2_Equipment requirements specifications (main equipment/common)
RT-(00000)-RSM-005 v.2_Equipment requirements specifications (main equipment/machines)
RT-(00000)-RSM-006 v.2_Equipment requirements specifications (main equipment/electrical equipment)
RT-(00000)-RSM-007 v.2_Equipment requirements specifications (main equipment/equipment used)
Details ÿ This specification inherits the design philosophy of existing production equipment.
For detailed items other than those described in this specification, please check as appropriate.
3. Responsibility
responsibility
Responsibility ÿ Designed to meet the conditions of this specification, each equipment requirement specification (main equipment), and transaction contract.
The contracted party that manufactures the equipment will be in charge of this.
Responsibility ÿ If any technical issues arise in the production of production equipment for the products covered by this specification,
The contractor will be responsible for resolving the issue, but technical issues will be discussed with the contractor.
We will discuss this separately and work together.
Responsibility ÿ Regarding the delivery date, if there is a concern that there will be a delay from the schedule due to progress status or unexpected circumstances, we will separately notify you.
Both companies will hold discussions.

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4. Information regarding delivery date and acceptance inspection
4-1. About delivery date and
acceptance inspection 10 months after finalizing specifications
Delivery date Acceptance inspection Delivery place
Reagent Building 1F Workroom 2 Acceptance inspection conditions
ÿEducation and training regarding operating explanations ÿSubmission of deliverables
4-2. Transport/packaging form and scope of work
Transport form ÿ Land transport ÿ Sea transport ÿ Air
transport Packaging form ÿ Wrapping ÿ Reinforced cardboard ÿ Pallet ÿ Skit ÿ Sealed wooden box
ÿ Opened wooden box ÿ Steel packaging ÿ Barrier packaging Delivery
form ÿ Pick up at our company ÿ Delivery on the vehicle ÿ Delivery under the eaves ÿ Delivery at the storage location ÿ
Home delivery Transportation burden ÿ No payment by your company ÿ Until our delivery completion ÿ Installation at our company ÿ
Others Installation Your company (ÿ Horizontal pulling from delivery entrance to installation location ÿ Equipment connection ÿ Centering ÿ Leveling)
Our company (ÿ Horizontal pulling from loading entrance to installation location ÿ Equipment connection ÿ Centering ÿ Leveling)
Material processing ÿ Your company ÿ Our company
Waste material processing ÿYour company ÿOur company ÿN/A *Equipment and accessories
Terms of trade ÿNone ÿEXW ÿFCA ÿCPT ÿCIP ÿDAP ÿDAT ÿDDP
ÿFAS ÿFOB ÿCFR ÿCIF

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5. Common specifications
5-1ÿ Common specifications
Production environment temperature 18-26ÿ
humidity 10-60% RH
ÿNo management ÿManagement Class 10,000
Cleanliness Operating time 24 hours continuous
Utility Air source Vacuum source ÿFactory side ÿEquipment side Equipment supply port set pressure: 0.4MPa
ÿFactory side ÿEquipment side
Piping Compressed air (primary side) color:-
SGP-W Compressed air (inside machine) Color: black
Urethane tube Vacuum Urethane tube Color: transparent blue
Primary side connection type ÿDirect piping (mouth type A) ÿCoupler (male)
Primary side construction ÿYour company ÿOur company
power supply Power supply (primary side) ÿAC100Vÿ1 ÿAC200Vÿ3
ÿOther ( )
Power supply (power) ÿAC100Vÿ1 ÿAC200Vÿ3
ÿDC24V ÿOthers ( )
Power supply (control) ÿDC12V ÿDC24V ÿOther (Primary side connection )
type ÿBreaker receiver ÿTerminal block receiver
Primary side construction ÿ Your company ÿ Our company
Power consumption 20kVA or less *Theoretical power consumption and target value
Frequency ÿ50Hz ÿ60Hz ÿ50•60Hz
Surface treatment General baking painting Munsell: 2.5Y8.5/2 (day coating: H22-85D)
(Steel-based) Film thickness 30ÿm or more
Black baked paint Black matte Film thickness 30ÿm or more
General Plating Bright Chromate (Unichrome)
Hardness plating required Hard chrome plating Film thickness 25ÿm or more
Precision plating required Electroless nickel plating Film thickness 5 to 10 ÿm
exterior Surface treatment General coating White alumite
(Aluminum-based) Black coating Black alumite (matte)
Hardness coating White hard alumite
Abrasion resistant coating TAFRAM
Surface treatment General treatment No.2B, BA, pickling *Discoloration areas due to heat
(SUS type) Decorative treatment ÿElectrolytic polishing ÿ#400 ÿHL
Noise countermeasures 75 dB or less *Measurement points: 1 m from the control panel, 1.2 to 1.5 m above the floor, 10 min
Connection with other equipment ÿNo ÿYes

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Overseas installation Export compatible ÿNone
ÿ Yes Departure: Arrival:
ÿIssuance of non-applicable certificate/obtainment
from manufacturer Regulations ÿRoHS Directive ÿREACH Regulation ÿCLP Regulation
language kinds ÿJapanese ÿEnglish ÿChinese ÿOther languages (Language used
ÿJapanese ÿEnglish ÿChinese ÿOther languages ( ))
*Words that cannot be written in Japanese are excluded.
Scope of use ÿAll ÿLimited Equipment
display: ÿOperation panel ÿInstruments ÿPL nameplate Document related: ÿCompleted
documents
Language switching ÿ No setting
ÿSettings available *Operation panel only
ÿEnglish ÿChinese ÿOther languages ( )
Can be written together ÿ Cannot be written together
ÿAlso listed *Excluding operation panel Legal
compliance Various laws and regulations Laws and regulations that should be considered when manufacturing equipment and selecting environmentally friendly equipment
ÿEnergy Saving Law ÿFreon Emission Control Act ÿWater
ÿAir Pollution Control Law ÿWater Pollution Prevention Act ÿSoil
Supply Law Contamination Countermeasures
ÿSewerage Law Act ÿVibration Control Act
ÿNoise Control Law ÿPoisonous and Deleterious Substances Control Act
ÿ Occupational Health and

ÿChemical Substance Emission Understanding and Management
Promotion Safety Law ÿ European regulations (RoHS Directive,
Act ÿFire Service Act REACH regulations/CLP regulations)
Safety Functions Appendix Please refer to and comply with the safety categories.
<From the Ministry of Health, Labor and Welfare>
https://www.mhlw.go.jp/bunya/roudoukijun/anzeneisei14/ dl/ks01-33.pdf
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5-2ÿ Equipment
performance Equipment performance Actual production capacity 514.3 pieces/h (7.0sec/piece)
*For items other than “equipment design ability,” the production evaluation
Production capacity value.
*At the time of acceptance inspection, 1 set must be secured within 3 hours/set x 3 sets. *NG
Dummy samples and malicious tests are conducted to ensure quality
and confirm operational stability.
Equipment 553.8 pieces/h (6.5sec/piece)
design ability *Equipment design values that ensure the operating capacity of the equipment and take into account
a safety factor of 2.9 or higher. (Refer to the table "Safety factor for functions" on the next page)
Operating personnel Material input/replacement: 0.5 people/equipment
Troubleshooting: 0.5 people/equipment Total 1 person/equipment
mean time between failures 24 hours/case/day
(MTBF) *Up to 1 case within 3 hours/set x 3set is allowed during acceptance inspection.
Mean time to repair 2.5 hours/time Within 2 cases/month
(MTTR) *During acceptance inspection, up to 1 item within 3 hours/set x 3set is allowed.
Hourly availability rate 92.5% or more
*If the load time is 8 hours, the stop time is within 0.6 h (=36 min). *The cumulative
stop time due to short stops during acceptance inspection is within 13.5 min within 3 hours/
set.
Time availability = Load time - Stop time

Load time ×100 [%]
•Load time [h] = Operating time - Planned stoppage time
•Stoppage time [h]: Equipment stops due to breakdown, setup, adjustment, etc.
time
Performance availability 91.0% or more

Performance availability = speed availability × net availability [%]
•Speed operation rate = standard cycle time Actual cycle time x
100 [%] •Net operation rate = production volume x actual cycle time
×100 [%]
Load time - Stop time /output:
Actual number of pieces produced (number of non-defective items) within load
Good product rate time 97.5% or more
•Good product rate = processed quantity – defective quantity

Processing quantity
×100 [%]
Total Equipment Efficiency 82.1% or
more Total Equipment Efficiency = Hourly Operating Rate x Performance
Operating Rate x Non-defective Product Rate 422.2 pieces/h or higher

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Safety factor for function
Analysis Material Load

No. Content function safety ratio
CAE variation variation
If that function breaks down, it will result in a serious disaster.

1 5.0 or higher 1.2 1.2 1.33 9.6
connect
If that function breaks, the machine will be completely destroyed.

2 3.0 or higher 1.2 1.2 1.33 5.7
and the line stops
If that function breaks down, the machine will stop.

3 1.5 or higher 1.2 1.2 1.33 2.9
and the line pauses.
If that function breaks, the minimum

Four 1.2 or higher 1.2 1.2 1.33 2.3
Stop safely while maintaining performance.
Even if that function breaks, there is a replacement function.

Five 1.1 or higher 1.2 1.2 1.33 2.1
work
6 It doesn't matter if the function is broken 1.0 or higher 1.2 1.2 1.33 1.9
Destroy as a priority when there is a problem

7 0.9 1.2 1.2 1.33 1.7
Where you want
When designing with the safety factor in mind, No. 3 in the table above should be used as the standard.
If it is unavoidable due to mechanical reasons, please follow No. 4 in the table above.
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5-3. Control specifications
Control panel material ÿSPCC ÿSUS304 BA
Paint color specification ÿNo ÿYes (Munsell: 2.5Y8.5/2 day coating: 22-85D)
Door ÿSingle swing ÿDouble swing ÿOtherÿ )
shape Protection structure First symbol (solid) Degree of protection: ÿ4 ÿ5 ÿ6 ÿX
Second symbol (water intrusion) Degree of protection: ÿ4 ÿ5 ÿ6 ÿX
Mounting position ÿFloor placement ÿInside equipment ÿMovable type
Dimensional restrictions ÿNo ÿYes

Indicator light ÿNo ÿYes(ÿ)
*RT-(00000)-RSM-004 According to each equipment requirement specification (main equipment)
Instrument installation ÿNot required ÿRequired
(ÿVoltmeter ÿAmmeter ÿPower totalizer ÿOther)

ÿNot required ÿRequired
Nameplate Operation panel Material ÿSPCC ÿSUS304 HL ÿAluminum
Paint color specification ÿNo ÿYes (Munsell: 2.5Y8.5/2 day coating: 22-85D)
door shape ÿNo door ÿSingle door ÿDouble door
Protection structure First symbol (solid) Degree of protection: ÿ4 ÿ5 ÿ6 ÿX
Second symbol (water intrusion) Degree of protection: ÿ4 ÿ5 ÿ6 ÿX
Mounting orientation ÿ Attached directly to equipment ÿ Embedded in equipment ÿ Movable pendant ÿ Movable free-standing
Touch panel ÿ No ÿ Yes (12 inch)

2 units (front/back of equipment)
Quantity Indicator ÿ No ÿ Yes (*)
(*) The color coding of the indicator lamps is as follows.
Color Lit Blink Meaning of Lit Device status

•- emergency stop
red abnormality alarm
-• Error stop, pressure abnormality, temperature abnormality, lubrication abnormality, overload, device abnormality
•- Each individual works

yellow Note
-• Remaining amount/alarm, tool replacement, no workpiece
•- During automatic operation
green safe, normal

-• Homing in progress, ready for operation, home position
White • - - Power on display

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6. Summary and subject product
Equipment overview Equipment name Reagent pack assembly equipment (K2)
Equipment configuration Reagent pack assembly ÿ Reagent dispensing into the pack (resin molded product)
Reagent pack assembly ÿAssemble packs, tips, and caps Attach reagent pack
label ÿAttach label to side of pack External dimensions
W5000×D2000×H2000mm
Import size restrictions: ÿ
None ÿ Yes ÿ Split structure W2500 x H2000mm or less
Product overview Product name Reagent pack CEA1c
Product configuration Packs, chips, caps, labels, individual packaging (* not included in this equipment)
The product shall be a one-piece specification.
reagent cartridge
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Product overview Material composition •Reagent pack (drawing: 62-25164A, 62-27415)

Material:
PP Model: J226T (Prime Polymer)
reagent pack
·filter
Material: Cellulose acetate membrane (pore size 0.45ÿm)

Model: C045A (Advantech Toyo)
Dimensions: Roll diameter ÿ293mm, width 100±1mm, total thickness 125±15ÿm
Roll length 100 -0/+5m, branch pipe 3 inch plastic core
Processing: Processed in the facility to ÿ4.2 +0.2/-0mm
filter
•Hydrophilic film
Material: PET non-
woven fabric Model: MF-80K (Japan
Vilene) Dimensions: Roll diameter ÿ293mm, width 100±3mm, total thickness
105±15ÿm, roll length 300±40m, branch pipe 3 inch plastic core
Processing: Processing to ÿ3.6±0.1mm in the facility
hydrophilic film
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Product Overview Material Composition •Electrode (Drawing: 64-25299)
Material: SUS304
Dimensions: outer diameter 0.82±0.01mm, inner diameter 0.50±0.02mm, length 3.5±0.1mm
electrode
•Laminated film bottom/top
Material: (Outside) Gas barrier film 12ÿm (Inside) Heat
seal OPP 20ÿm Model: (Outside) GX-PF
(Toppan Printing) (Inside) HC-OP (Mitsui
Chemicals Tohcello) Dimensions: Roll
diameter ÿ293mm, width 100±3mm, total Thickness 35±6ÿm
Roll length 500 -0/+5m, branch pipe 3 inch plastic core
Processing: (Bottom) Machined to ÿ6.0±0.2mm in equipment
(Top) Machined to 60.9 -0.1/0×16.2 -0.1/0mm in equipment
bottom laminate
top laminate
•Slight adhesive film
Material: PET
Model: EM-L60 (Higashiyama Film)
Dimensions: (For bottom lamination) Roll diameter ÿ170mm, Width 100mm,
Thickness 50ÿm Roll length 300 -0/+5m, Branch tube
3 inch plastic core (For top lamination) Roll diameter ÿ170mm, Width
100mm, Thickness 75ÿm Roll length 300 -0/+5m,
Branch 3 inch plastic core Processing: Used as a carrier sheet for bottom and top lamination
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Product overview Material composition •Reagent solution 1/2 (Reagent R1/2 HbA1c)
Filled liquid volume: 60±3 ÿL each
The red part contains the R1 reagent, and the green part contains the R2 reagent.
•Cap (drawing: 63-26115B)

Material: PP, general purpose grade
cap
•Chip A (Drawing: KK131001-B24)

Material: Acrylic resin, Acrypet MF001
•Chip B (drawing: KK131001-C17)
Material: Acrylic resin, Acrypet MF001
chips
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Product Overview Material Composition/Label
Material: Base material + Adhesive layer,
Sepa mount Model: Yupo #80 (Lintec) + PAT1 8K (Lintec), Sepa mount
Dimensions: Slit width 33±1mm, label size 9±0.5mm×18±
0.5mm, feed pitch 28±0.5mm, branch tube 3 inch, roll length

300m/roll
label
product label
Lot Info Label (Label for Cleaning Cartridge)

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7. Detailed specifications
Detailed specifications
7-1ÿ Line configuration image

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7-2. Line details (common process)
[Common-UNIT] Reagent pack transfer
<Summary> Automatically and continuously transports loaded reagent packs downstream 1ST at a time.
<Operation> ÿ The reagent pack is temporarily placed in the desired position.
(2) The reagent pack transfer at the standby position rises to the height of the temporarily placed reagent pack.
(3) Grip the reagent pack on the reagent pack transfer side
ÿAfter grasping the reagent pack, rise further
(5) Carry the reagent pack to the next ST position
ÿ Descend to any position where the reagent pack is temporarily placed
(7) Releasing the grip of the reagent pack on the reagent pack transfer side
(8) Reagent pack transfer down to standby position height
(9) Move the reagent pack transfer to the previous ST position.
Requirements Standard value Verification method Notes
•Has a function that prevents the reagent pack from changing its posture during transfer. •Has a function that prevents the Visual inspection N/A
reagent pack from falling during transfer. •Has a function that prevents the reagent pack from falling during transfer. •When Visual inspection N/A
placing the reagent pack at the destination ST, the posture does not change.
have a function Visually N/A
can be placed
•The status of reagent packs can be monitored during transfer.
Predicted due to transfer failure or operator's discharge outside the system

If there is a discrepancy with the inventory status, the work
alarm notification to
•Dispensed reagents do not spill from reagent packs during transfer

thing
•Do not damage the reagent pack at any time.

Visually N/A
no damage
•Efforts should be made to minimize the transfer takt time. Target tact Inside the PLC
N/A
1.5sec timer
In-process inspection requirements Standard value Good/bad judgment Remarks
N/A N/A N/A N/A

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7-3. Line details (reagent pack assembly process)
[A-UNIT] ST-00 Pack input (parts feeder P/F)
<Summary> Insert the reagent pack into the equipment and automatically
Enables continuous operation
<Operation> (1) The operator puts the reagent in the hopper or drum P/F.
supply pack
ÿ Only when equipment commands are requested, reagent packs are stored in drums.
Transport from P/F to the specified position via straight P/F
let reagent pack
ÿ Cut out the reagent packs in the designated positions one by one.
ÿAdd reagent packs to the equipment each time they are requested.
- Workers can manually load reagent packs into the P/F Provided with the function - Reagent Visual N/A
packs must be supplied to the inside of the device with the P/F Provided with the function Visual N/A
hopper for intermittent supply Provided with a Visual N/A
•P/F control must be via PLC

And individual control is NG
•Uninterrupted supply of reagent packs •Minimize within the requested takt Visual inspection N/A
the number of times reagent packs are supplied 30ÿ60min/time Visual inspection N/A

that there is
In-process inspection requirements Standard value Pass/Fail Judgment Notes
N/A N/A N/A N/A
[A-UNIT] ST-01 Cleaning (static removal blow/dust collection)
<Summary> Removes foreign matter attached to the reagent pack and collects dust.
<Operation> ÿ Fix the loaded reagent pack
ÿ Blow air while eliminating static electricity inside the reagent pack.
(3) Collect dust from the air-blown object
Requirements Standard Verification method Remarks
•Eliminate static electricity and clean with air blow inside and outside the reagent pack. value Charge ±100V or less Charge measurement
to do 0.3mm2 or more Visually N/A
No foreign objects Miscellaneous sample
•When cleaning with air blow, do not spread to the surrounding area. - -
N/A
to collect dust
In-process inspection requirements Standard value Good/bad judgment Remarks
N/A N/A N/A N/A

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[A-UNIT] ST-02 Bottom laminate (punching and welding) <Summary>
A laminate film (hereinafter referred to as laminate) is semi-punched
(hereinafter referred to as kiss cut) in the facility and
processed as ``bottom laminate''. Weld the laminate to the
bottom of the reagent pack (in 2 places) and attach

Bottom lamination welding position
the laminate and the slightly adhesive film (which acts
as a carrier sheet). Kiss-cut only the laminate. ) ÿ Attach
the laminate and the slightly adhesive film
ÿ Kiss-cut only the laminate to the size of the bottom laminate ÿ Cut out only the kiss-cut bottom laminate
onto a temporary table ÿ Cut out the bottom laminate based on
the alignment information of ST-03 Instruct the pickup position to the unit to
be transported. ÿ The transport unit picks up the two bottom laminates on the
temporary table at the specified pickup position. ÿ The transport unit moves the bottom laminate to the reagent pack welding
position, and welds the reagent pack. Transfer the bottom lamination to the face. At this time, the reagent pack side sucks
the bottom laminate and holds it until welding is completed. ÿ Weld the retained bottom laminate. ÿ Roll up and collect the
kiss-cut punched film.
Requirements Standard value Verification method Remarks
•Materials can be set Roll W100±3mm×
lamination (both front and back) t 35±6ÿm×
Winding length 500 -0/+5m Visually N/A
ÿ300mm
3 inch plastic core
•Materials can be set W100±3mm×
Roll-shaped non-separated/semi-adhesive film without separator t 50±5ÿm×
length 300±5m Visually N/A
ÿ220mm
3 inch plastic core
•The branch tube of each film is for 3 inches by air drive Placore
have a function N/A
Adopt core chuck Putting on and taking off
•The unwinding and rewinding mechanisms for each film are

tension adjustment unit
Weight dancer roll unit to manage lum tension Instrument N/A
25N
attach the
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•The film after punching can be collected in roll form.

thing
•The adhesion state between the laminate and the slightly adhesive film is Bubble ÿ0.5mm
and no phase shift below
The crimping force at the time of application can be changed by air pressure drive. Phase shift ±0.5mm
caliper N/A
below
Crimping force 50ÿ
200N/100mm
•The laminate is kiss-cut. ÿ6.0±0.2 mm Measuring instrument N/A
•For laminate punching, use the descending end of the pinnacle blade
Provide a positioning mechanism
pinnacle blade
Height adjustment unit
Instrument N/A
0.01mm
resin pedestal
sim
*Does not include adjustment allowance due to floating clearance
•At the time of maintenance,

Take measures to prevent falling
•The bottom laminate cut out for the temporary table is From the temporary location
to electrify At 50mm upstream Charge measurement N/A
The ionizer should have a self-diagnosis function. Charge ±100V or less
•On the temporary table, 8 pieces of bottom lamination are cut out at the same time.
to be done
•Supply bottom lamination to the temporary placement table within the required takt time 3 retries
Inside the PLC
If it is not possible, retry is the shortest and minimum number of times. retry time N/A
timer
to be 2 times/within 5 seconds
•A stock sensor is installed on the temporary table and preset
(threshold set) function

To allow workers to check the inventory status when presetting
Provide a warning message screen for
•Set for continuous punching and cutting of laminate

Continuous operation 100 times Visual inspection N/A
have a tinging mode
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•A mechanism should be provided so that the stop position of the bottom lamination that is
transferred to the temporary placement table is parallel to the reagent pack before welding. have a function Visually N/A
and
•Film transport meandering adjustment mechanism different from the above mechanism
to provide
•Equipped with a transfer device that simultaneously adsorbs the two bottom laminations
cut out on the temporary placement table and transports them to the reagent pack. have a function Visually N/A
to kick
•The transfer machine that transports the reagent pack can determine whether
the bottom laminate is not adsorbed or the vacuum pressure system is clogged.
flow rate
Set the threshold so that it is possible to check Visually N/A
0.01ÿ5.00L/min
for clogging of the vacuum pressure system
Flow rate resolution 0.001L/min
•An alignment function is provided to ensure the accuracy of the welding alignment
Araimen
position of the bottom laminate, and the aligned bottom laminate is Adjustment unit N/A
information
welded to the reagent pack. X/Y: 0.01mm
•Ability to log alignment results to PLC Alignment amount csv file N/A
*R1, R2 reagents XY resolution file export
0.01mm
•Welding position alignment amount for each of R1 and R2 reagents n=900 pieces
Display (X,Y) as a line graph on the touch panel X/Y axis: ±1.0mm display
Visually N/A
thing resolution
0.01mm
•There should be no leakage when welding the bottom laminate to the reagent pack. Welding position deviation
The welding method is heat welding. Welding center position
±0.5mm or less
offline decompression
leak
-66.7kPa•5min
Pressure reducer N/A
No wrinkles, floats, damage
*When heat welding
Welding temperature: 162±
2°C
Resolution 0.1°C
Welding time: 1.5 sec

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•The welding temperature is displayed on the touch panel as a line graph. n=120min minutes
letting Range: 155-165°C
Also, display the alert threshold as a red line in the graph. Lower threshold limit 157.5ÿ Visually N/A
thing Upper threshold 162.5ÿ
Display resolution 0.1ÿ
•In order to prevent misalignment before welding, on the reagent pack side.
A mechanism (suction mechanism) is provided to temporarily hold the bottom laminate, have a function Visually N/A
Adsorption pressure can be adjusted
•Apply a voltage to the thermocouple using a calibrated measuring instrument.

DC Signa
Capable of inspecting the condition of thermocouples have a function N/A
le sauce
It must also have a connector to connect it to the measuring device.
•Laminated punching is done using Pinnacle blade (Hanedashiss). durability

-
N/A
with Ponzi) Over 700,000 times
•Manage the number of operations below (current value, replacement value)
and be able to display and change settings on the touch panel. have a function Visually N/A
Pinnacle blade, honeydashi sponge, die (resin pedestal)
•Replacement of pinnacle blades must have a reproducible structure. Visually N/A
•The amount of input materials used can be monitored.
<Measurement management during automatic operation>
Daily usage: total usage per day
Accumulated amount used: total amount used per 1 lot of material
*Used amount can be entered using 10 keys for both same-day and cumulative usage.
* There is a button to reset the measured value
<Individual input to be reflected in measurement management in manual mode> Usage amount ±5m Visually N/A
Fixed amount used: Amount used when replacing materials
Arbitrary usage amount: usage amount for unforeseen circumstances
*For both fixed value and arbitrary amount, 10 key input is possible.
After input, usage information is automatically added to the current day/accumulated usage amount.
To reflect
*Addition and subtraction input is possible for arbitrary usage amount.
•Welding position alignment amount (X, Y)
* If the non-standard value exceeds three times in a row, an alert is sent to the operator. Alignment amount
Image inspection N/A
home notification Within ±0.5mm
*R1, R2 reagents
Document Control #:
Ver.1 Page: 22ÿ70
[A-UNIT] ST-03 Bottom lamination (position inspection)
<Summary> Image of the position of the bottom lamination welded with ST-02
Inspect the welding condition with
<Operations> ÿ Fix the reagent pack and determine the inspection position
ÿ Inspect the welding state of the bottom laminate with
images ÿ Pass the image inspection results to the next ST Bottom laminate welding position inspection
ÿ Skip NG products without performing the subsequent process
Requirement for discharging outside the
system at ST-16 Standard Verification method Notes
•Be able to identify the welding state of the bottom laminate value Welding position
Inspection contents include welding position deviation, deviation From welding center position
surface wrinkles, air bubbles, flaws/damage, and ±0.5mm or less Air

Instrument N/A
detection of unwelded areas (lifting) bubbles ÿ0.5mm or
*R1, R2 reagents more NG
No wrinkles, lifting, or damage
•If the image test is judged as NG, from the next ST onwards,
Discharge outside the system using the discharge ST without performing post-processing.
•Ability to log image test results to PLC Pickup position

csv file
*R1, R2 reagent Welding position N/A
file export
deviation amount XY
•Display the amount of welding position deviation (X, Y) for each of R1 resolution 1ÿm
and R2 reagents as a line graph on the touch panel.Also, display n=900 pieces XY axis:
the alert threshold as a red line in the graph. ±0.30mm Threshold lower
Visually N/A
thing limit -0.10mm Threshold upper limit +0.10mm
Display resolution
0.01mm
In-process inspection requirements Standard Pass/Fail Judgment Notes
•Welding position deviation (X, value Welding position

Imaging N/A
Y) *R1, R2 reagent deviation Within ±0.5mm
•Detection of surface wrinkles, scratches/damage, unwelded parts (floating) Contaminant sample

Image inspection N/A
*R1, R2 reagents 0.3mm2 or more
•Bubbles is NG Air bubble

Imaging N/A
*R1, R2 reagents ÿ0.5mm or more NG
Document Control #:
Ver.1 Page: 23ÿ70
[A-UNIT] ST-04 Temporary Placement
<Overview> Use as a relay position between STs as an empty stage
<Action> N/A
•When temporarily positioning the reagent pack, remove dirt without damaging it.
N/A Visually N/A
to have a structure that does not attach
N/A N/A N/A N/A
[A-UNIT] ST-05 Inversion (pack upside down)
<Summary> The reagent pack is transported on the bottom side and then turned over on the top side.
<Operation> ÿ Grasp the reagent pack on the bottom
ÿ Raise the reagent pack and turn it upside down.
ÿ Lower the reagent pack and open it with the top side
•Do not damage or stain the reagent pack or bottom laminate.

N/A Visually N/A
structure
•When inverting or raising/lowering the reagent pack, check the piping and arrangement. Piping: no leak Visually
N/A
No line damage Wiring: no disconnection action
•Do not drop the reagent pack when inverting or lifting up and down. •When no drop action N/A
placing the reagent pack after inverting, make sure that the position remains unchanged.
no drop motion N/A
thing
N/A N/A N/A N/A

Document Control #:
Ver.1 Page: 24ÿ70
[A-UNIT] ST-06 Filter (punching/welding pasting) <Summary>
Process the filter in the facility and weld the outer periphery to the designated position of the
reagent pack <Operation> ÿ Set the roll-shaped filter ÿ
Filter size ÿTemporarily place the fully cut
filter
deliver to table
Filter
ÿBased on the alignment information of ST-07, instruct the pickup position to the unit that transports the filter. ÿThe
transport unit adsorbs one filter on the temporary table at the specified pickup position. ÿThe transport unit picks
up the reagent pack. Move the filter to the welding position and transfer the filter to the reagent pack welding surface.
At this time, the reagent pack side sucks the filter and holds it until welding is completed. ÿ Weld the held filter.
ÿ Wind up and collect the filter after being
fully cut and punched.
•Materials can be set W100±1mm ×
roll filter t 125±15ÿm× roll
length 100 -0/+5m Visually N/A
ÿ293mm
3 inch plastic core
•The branch pipe of each filter is air-driven for 3 inches. Placore

have a function N/A
Adopt core chuck detachable
•The unwinding and winding mechanism of each filter includes

Tension adjustment unit
a weight dancer roll unit that manages filter tension. Instrument N/A
25N
attach the
•After punching, the filter can be collected in roll form.

and
•The filter must be fully cut. •When punching ÿ4.2 +0.2/-0 mm Measuring instrument N/A
the filter, place the descending end of the pinnacle blade in the
Provide a mechanism for positioning
pinnacle blade
Instrument N/A
0.01mm
resin pedestal
sim

Document Control #:
Ver.1 Page: 25ÿ70
•The filter punching mechanism is designed to prevent it from falling during maintenance.
take preventive measures
- Static electricity must be removed from the punched filter. From the temporary location
The ionizer comes with discharge needle replacement and air volume adjustment. At 50mm upstream Charge measurement N/A
Ru Charge ±100V or less
•13 filters are transported to the temporary table at the same time.
to be sent
•Supply the filter to the temporary table within the required tact 3 retries
Inside the PLC
If it is not possible, retry is the shortest and minimum number of times. retry time N/A
timer
to be 2 times/within 5 seconds

•Continuous punching of filters and temporary storage table

Must have a setting mode for transport
•The stop position of the filter transported to the temporary table is
Provide a mechanism that is parallel to the reagent pack before welding. have a function Visually N/A
and
•Film transport meandering adjustment mechanism different from the above mechanism
to provide
•Suction of one filter transported to the temporary placement table

and provide a transfer machine to transport it to the reagent pack.
•The filter is
Distinguish between unadsorbed state and vacuum pressure system clogging state
flow rate
Set thresholds where possible Visually N/A
0.01ÿ5.00L/min
In addition, make it possible to check for clogging of the vacuum pressure system.
Flow resolution 0.001L/min
•Alignment to secure welding position accuracy of filter alignment

Araimen
A function is provided, and an aligned filter is added to the reagent Adjustment unit N/A
information
welding to the pack X/Y: 0.01mm
•Ability to log alignment results to PLC Alignment amount

csv file
XY resolution N/A
file export
0.01mm
Document Control #:
Ver.1 Page: 26ÿ70
Requirements Standard Verification method Notes
•Display a scatter diagram graph of the filter welding position value n=50
alignment amount (X, Y) on the touch panel. Also, pieces XY axis: ±0.50mm
display the alert threshold value in a red line in the graph. Threshold X±0.25mm
Visually N/A
thing Threshold Y±0.25mm
Display resolution
0.01mm
•Only one filter should be welded to the reagent pack Welding position
without misalignment and air leakage.The deviation Welding center position ±
welding method should be ultrasonic welding. 0.5mm or less
Withstand pressure 50kPa/
10sec No damage
Welding waiting time
500msec
Welding time Damage confirmation N/A

100•150•
200msec
cooling time
200msec
surface pressure
3.17•3.96•
4.75N/mm2
Adjustment -101.3~0kPa
A mechanism to temporarily hold the filter (suction mechanism) must be Visually N/A
Resolution 0.1kPa
provided, and suction pressure can be adjusted.
•For lamination punching, use Pinnacle blade (Hanedasyspo) durability

-
N/A
) More than 100,000 times
•The following number of operations (current value, recommended
replacement value) can be managed, touch panel display, and have a function Visually N/A
settings can be changed. Pinnacle blade, honeydew sponge, die (resin pedestal)
•The pinnacle blade replacement must have a reproducible structure and function. Visually N/A
Document Control #:
Ver.1 Page: 27ÿ70
Cumulative usage: Total usage per 1 lot of material
*There is a button to reset the measured values.
Fixed value usage amount: usage amount when exchanging materials
*For both fixed value and arbitrary usage amount, 10 key inputs are possible.
To reflect

Alignment amount
*If the value exceeds the standard value three times in a row, an alert will be sent to the operator. Image inspection N/A
Within ±0.5mm
notification
Document Control #:
Ver.1 Page: 28ÿ70
[A-UNIT] ST-07 Filter (leakage test) <Outline> Tests by
applying pressure to check if the outer periphery of the filter is welded without leakage <Operation> (1) Fix the reagent pack and move the test
position. stipulate
ÿ Pressurize the filter part from the bottom of the reagent pack ÿ
Measure the flow rate and pressure when the pressurized air passes through the filter to determine pass/fail ÿ NG
products are skipped without performing the post-process, and the system is returned to ST-16. Requirements
for external discharge Standard value Verification method Remarks
•It is possible to identify the welded state of the filter.Inspection pressurized leak
contents include filter permeation flow rate and pressure measurement during 0.09ÿ0.13L/min• Instrument N/A
permeation by pressurization. 33.5±1.0kPa
•If the leakage test is judged as NG, from the next ST onwards,
•Be able to log leakage test results to PLC judgment result
ST-06 Temporary table
POS history Filter csv file export

N/A
permeation flow rate/
pressure during permeation
XY resolution 1ÿm
•Line graph of filter permeation flow rate on touch panel n=900 pieces
to display Flow rate 0.06~
Also, display the threshold value as a red line in the graph. 0.16L/min
lower threshold
0.09L/min Visually N/A
threshold upper limit
0.13L/min
Display resolution
0.01L/min
•Display a line graph of the filter pressure value on the touch panel. n=900 pieces
Also, display the alert Pressure 25.0ÿ
threshold as a red line in the graph. 40.0kPa

Visually N/A
thing Threshold lower limit 29.0kPa
Display resolution
0.1 kPa
•Filter permeation flow rate when pressurized 0.09ÿ0.13L/min• Flow
At 33.5±1.0kPa meter (digital N/A
Resolution 0.01L/min output)

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Ver.1 Page: 29/70
•Filter permeation pressure when pressurized Pressure

29.0kPa or more
gauge (digital N/A
Resolution 0.1kPa
output)
[A-UNIT] ST-08,ST-09 SUS pipe (insertion 1/insertion 2) <Summary> Press fit the
SUS pipe into the reagent pack <Operation> ÿ Supplied to the parts
feeder (PF)
Take out one SUS pipe.
ÿ Put the removed SUS pipe into a reagent pack
transport it to the specified location.

SUS pipe insertion position
ÿPress the SUS pipe into the reagent pack
In the figure on the right, the light blue color represents the electrode press-in part, and the blue color represents the exposed electrode
Requirements part. Standard value Verification method Remarks
•Materials can be set Outer diameter 0.82±
Also, be able to grasp one piece at a time. 0.01mm
SUS pipe bulk packing Inner diameter 0.50± Visually N/A
0.02mm
Length 3.5±0.1mm
•Setting materials, reloading when it is not possible to grasp each material one by one. Number of retries: 3
Inside the PLC
The lie must be the shortest and the least number of times. times Retry time: 2 N/A
timer
times/within 5 seconds
•When transporting SUS pipes, remove static electricity.

Charged within ±100V
The ionizer comes with discharge needle replacement and air volume adjustment. Charge measurement N/A
in bulk condition
Ru
•Provide a transfer machine that adsorbs one cut and transported SUS pipe
and transports it to the reagent pack.
•At the transfer machine that transports the reagent pack, the SUS pipe
flow rate
Set the threshold so that it is possible to check for Visually N/A
0.01ÿ5.00L/min
clogging of the vacuum pressure system

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Ver.1 Page: 30/70
•The reagent pack should not be scraped when press-fitting the SUS pipe.
<OK product> <NG product>
*NG product The red circled part is a scratch mark during press fitting.
*Inspect the press-fit condition using ST-10.
•When press-fitting into the reagent pack,
SUS pipe end surfaces must be aligned
Tolerance ±0.2mm Measuring instrument N/A
•It is possible to monitor the press-fitting state of the SUS pipe.

Resistance value when press fitting
What is monitored is the resistance value during press-fitting. Visually N/A
Resolution 0.1A
*Load current value if electric
•St-08 and ST-09 resistance values on the touch panel for n=900
Displaying a line graph Range: 0-1000mA

Visually N/A
Also, display the alert threshold as a red line in the graph. Threshold upper limit 400mA
thing Display resolution 0.1A
N/A N/A N/A N/A

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Ver.1 Page: 31/70
[B-UNIT] ST-10 SUS pipe (pipe presence/absence inspection)
<Overview> The state of press-fitting of SUS pipes performed in ST-08 and ST-09
inspect by image
<Operation> (1) Fix the reagent pack and determine the inspection position
ÿ Inspect the press-fit condition of insertion 1 from the press-fit surface using images
ÿ After inspection of insertion 1, the camera can image insertion 2 SUS pipe insertion position
move to position
ÿ Inspect the press-fit condition of insertion 2 from the press-fit surface using images
ÿNG products are skipped without performing the post-process and are discharged from the system at ST-16.
•It is possible to identify the press-fit state of the SUS pipe.
The inspection contents include whether or not the SUS pipe is press-fitted, and whether the SUS pipe is press-fitted or not.
Detection of foreign matter inside, scratch/damage condition of reagent pack
Internal foreign matter is identified by the degree of blockage of the inner diameter of the SUS pipe.
Presence/absence determination Visually

N/A
Foreign object detection image test
•Even if the camera moves and stops,

good things
•Ability to log image test results to PLC csv file

Presence/absence determination result N/A
*Insert 1, Insert 2 file export
•Whether or not SUS pipe is press-fitted Presence/absence detection Image inspection N/A
•Foreign matter detection inside SUS pipe (1) Inner diameter blockage
Imaging N/A
Scraped condition of reagent pack 30% or more is NG
•Detection of foreign objects inside SUS pipe ÿ Contaminant sample 0.3mm2

Imaging N/A
Foreign matter during processing and cleaning of SUS pipes Above is no good
•Scratches and damage to the reagent pack during press-fitting Differences from non-press fit products Image inspection N/A
Document Control #:
Ver.1 Page: 32ÿ70
[B-UNIT] ST-11 Hydrophilic film (punching/welding pasting)

<Overview> Processing hydrophilic film in the facility,
Welding position
Paste it in place on the reagent pack

<Operation> ÿ Set the roll-shaped hydrophilic film
ÿ Full cut to the size of the hydrophilic film
ÿ Temporarily place the fully cut hydrophilic film
deliver to table hydrophilic film
ÿBased on the alignment information of ST-12, instruct the pickup position to the unit that transports the hydrophilic film.
do
ÿPlace one piece of hydrophilic film on the temporary table at the designated pickup position using the transport unit.
adsorption
(6) The transfer unit moves the hydrophilic film to the reagent pack welding position, and attaches it to the reagent pack welding surface.
Deliver the hydrophilic film. At that time, the hydrophilic film is sucked on the reagent pack side to complete the welding.
hold until
ÿWeld the retained hydrophilic film
ÿThe hydrophilic film after being fully cut and punched is rolled up and collected.

Rolled hydrophilic film roll t105±15ÿm×length
300±40m Visually N/A
ÿ293mm
3 inch plastic core
have a function N/A
•The hydrophilic film unwinding and winding mechanism has a hydrophilic film.
Weight dancer row to manage water film tension Measuring instrument
25N
unit
•The hydrophilic film after punching can be collected in roll form.
thing
•Hydrophilic film is fully cut ÿ3.6±0.1mm Measuring instrument N/A

Document Control #:
Ver.1 Page: 33ÿ70
•Descent end of pinnacle blade for punching hydrophilic film
Provide a mechanism for positioning the
pinnacle blade
Instrument N/A
0.01mm
resin pedestal
sim
•The hydrophilic film punching mechanism has a

take measures to prevent
•Eliminate static electricity from the hydrophilic film to be punched. From the temporary location
The ionizer is equipped with discharge needle replacement and air volume adjustment. At 50mm upstream Charge measurement N/A
do Charge ±100V or less
•15 hydrophilic films are placed on the temporary table at the same time.
to be transported
•Hydrophilic film is placed on the temporary table within the required tact. 3 retries
Inside the PLC
Shortest and smallest retry when supply is unavailable retry time N/A
timer
Must be the number of times 2 times/within 5 seconds

•Continuous punching of hydrophilic film and temporary table

•Have a setting mode for transporting the hydrophilic film to the
temporary storage table.
The position is designed to be parallel to the reagent pack before welding. have a function Visually N/A
to kick
•Hydrophilic film conveyance meandering adjustment different from the above mechanism
provide a mechanism
•One piece of hydrophilic film transported to the temporary table
A transfer machine is installed to adsorb and transport it to the reagent pack. have a function Visually N/A
thing
Document Control #:
Ver.1 Page: 34ÿ70
•The transfer machine transports the hydrophilic film to the reagent pack.
Distinguish between when the vacuum pressure system is not adsorbed and when the vacuum pressure system is clogged.
flow rate
Set a threshold so that Visually N/A
0.01ÿ5.00L/min
•Alignment to ensure accuracy of welding position of hydrophilic film alignment

Araimen
with an aligned filter function. Adjustment unit N/A
information
Weld to reagent pack X/Y: 0.01mm

csv file
XY resolution N/A
file export
0.01mm
•Welding position alignment amount (X, Y) on touch panel for n=50
display a line graph XY axis: ±0.5mm
Also, display the alert threshold as a red line in the graph. Threshold X±0.25mm
Visually N/A
thing Threshold Y±0.25mm
Display resolution
0.01mm
•Hydrophilic film welding to the reagent pack may cause misalignment, Welding position misalignment
And only one sheet can be welded without air leakage. Welding center position ±
The welding method is heat welding. 0.5mm or less
no damage
*When heat welding Damage confirmation N/A
Welding temperature: 198~
202ÿ
Resolution 0.1ÿ
Welding time: 0.4sec
•When transferring from the temporary storage table to the reagent pack,
Be sure to monitor whether there is only one hydrophilic film. - Check
that the welding temperature is displayed as a line graph on the touch panel. n=120min minutes
letting Range: 195-205ÿ
Also, display the alert threshold as a red line in the graph. Lower threshold 197.5ÿ Visually N/A
thing Upper threshold 202.5ÿ
Display resolution 0.1ÿ
•The hydrophilic film should be welded at one point.•The welded Welding part ÿ1mm Measuring instrument N/A
part should be at least 1mm away from the center of the electrode. have a function Visually N/A
Document Control #:
Ver.1 Page: 35/70
•Other than the welding surface, the reagent pack molded product and hydrophilic film
do not touch the film.
A mechanism (suction mechanism) is installed to temporarily hold the hydrophilic film. have a function Visually N/A
and the adsorption pressure can be adjusted
•Hydrophilic film punching is done using Pinnacle blade (Hanedasys).
(without ponzi + with plunger)
durability
-
N/A
Over 260,000 times
and be able to display and change settings on the touch panel. have a function Visually N/A
Pinnacle blade, plunger, die (resin base)
•The replacement of the pinnacle blade must have a reproducible structure. •It must be possible to Visually N/A
monitor the amount of input material used.
To reflect

Document Control #:
Ver.1 Page: 36ÿ70

Alignment amount
*If the value exceeds the standard value three times in a row, an alert will be sent to the operator. Imaging N/A
Within ±0.5mm
notification
•Air blow the hydrophilic film from the bottom side after welding.
and conduct a weldability inspection.
Document Control #:
Ver.1 Page: 37ÿ70
[B-UNIT] ST-12 Filter/Hydrophilic Film (Position Inspection) <Summary>
Inspect the welding position and surface condition of the ST-06 filter and
hydrophilic film
ST-11 Hydrophilic Film using images <Operation> ÿ Fix
the reagent pack to determine the inspection position.
ÿImage showing the welding condition of filter and hydrophilic film
Inspect ÿ
filter
Pass the image inspection results to the next ST ÿ Skip
post-processing for NG products.
Requirement for discharging outside the
system at ST-16 Standard Verification method Remarks
•It is possible to identify the welding condition of the value Welding position
filter.Inspection contents include welding position deviation, surface deviation From welding center position
wrinkles, scratches/ ±0.5mm or less No Instrument N/A
damage condition, detection of unwelded or not wrinkles or damage
notification Presence of
•It is possible to identify the welded state of the hydrophilic film. welding Welding position
Inspection details include welding position deviation, flaw/damage deviation From welding center position
status detection of non-welding, multiple welding ±0.5mm or less Instrument N/A
*If the value exceeds the standard value three times in a row, an alert will be sent to the operator. Scratches, no damage, presence/
notification absence of welding, multiple detection

csv file
* Both filter and hydrophilic film Welding position deviation N/A
file export
XY resolution 1ÿm
•Display the amount of welding position deviation (X, Y) for each of n=50 pieces
the filter and hydrophilic film in a scatter diagram graph on the touch XY: ±500ÿm
panel. Threshold X±250ÿm Visually N/A
Also, display the alert threshold as a red line in the graph. Threshold Y±250ÿm
thing Display resolution 1ÿm
value Welding
•Welding position misalignment Imaging N/A
position deviation Within ±0.5mm
•Surface wrinkles, scratches/damage, chipping, Contaminant sample

Imaging N/A
Unwelded part detection (floating) 0.3mm2 or more is NG
•Multiple welding detection 2 or more images are NG Image inspection N/A

Document Control #:
Ver.1 Page: 38ÿ70
value Matching rate 90% or less

•Roundness of welded material = Detection of irregular shape Imaging N/A
is no good
Contaminant sample 0.3mm2

•Foreign matter inspection other than welded matter Imaging N/A
Above is no good
[B-UNIT] ST-13 Dispensing 1/2 (reagent liquid dispensing/R1, R2 reagent)
<Summary> Dispense a fixed amount of reagent 1 and reagent 2 to the specified location.
Dispense with a syringe
<Operation> (1) Fix the reagent pack and determine the dispensing position
(2) Lower the needle at the tip of the syringe
(3) Dispense the specified amount to the R1 side

The red part contains the R1 reagent, and the green part contains the R2 reagent.
ÿ Raise the needle at the tip of the syringe
ÿ Move the syringe to the R2 side
ÿ Lower the needle at the tip of the syringe
ÿDispense the specified amount to the R2 side
ÿ Raise the needle at the tip of the syringe
(9) Move the syringe to the R1 side
*Check if the liquid has run out in the discard mode.
•Adjust the setting conditions so that a fixed amount can be dispensed. •The 60±3ÿL Instrument N/A
dispenser should be a syringe, and the reagent volume should be at its maximum capacity.
Select a model that allows you to set the amount, and then adjust the dispensing operation and system. Volume 340mL or more Visual inspection N/A
There should be no problem in replacing the ring.
•Dispenser, controller to adjust the amount dispensed, and air

N/A Visually N/A
Use regulators selected by our company.
•Controller and air regulator to adjust the dispensing amount Estimated installation height
motion N/A
The rotor must be in a position that is easy for the operator to adjust. up to 1500mm
•The syringe is designed to be easy to attach, remove and clean. Approximate attachment/detachment time
motion N/A
thing 1min
Preventive cover installation

•Prevent evaporation, drying, contamination, and contamination of the solution. Visually N/A
*Only when necessary
•Dispensing only within the specified volume without scattering on the top of the reagent pack. on reagent paper
N/A
There is no reagent attached to the top of the reagent pack. Reagent adhesion NG reaction
N/A N/A N/A N/A

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Ver.1 Page: 39ÿ70
[B-UNIT] ST-14 Top surface lamination (punching/welding) <Outline>
Semi-punching (hereinafter referred to as kiss cut) the laminate film
(hereinafter referred to as laminate) in the equipment and
processing it as "top surface lamination" and weld it to
the top surface of the reagent pack (1 place). Kiss-
cut only the laminate to the one with the laminate top laminate
and slightly adhesive film (which acts as a carrier sheet)
attached. 2) Laminate and tacky film are
pasted together 3) Full cut the perforated part and kiss cut only the laminate to the size of the top lamination
At this time, perform both processing at the same position
(4) Cut out only the kiss-cut top lamination on the temporary placement table (5)
Based on the alignment information of ST-15, instruct the pickup position to the unit that transports the top lamination (6)
Send the top lamination on the temporary placement table to the transport unit (7) The transfer unit moves the top
lamination to the reagent pack welding position, and transfers the top lamination to the reagent pack welding surface.
Temporarily weld the top lamination on the upper surface of the reagent pack at the time of delivery. Hold
until final welding is completed
ÿ Final welding of the held top lamination ÿ Roll
up and collect the kiss-cut punched film
•Materials can be set Roll W100±3mm×
lamination (both front and back) t 35±6ÿm×

Visually N/A
length 500 -0/+5m,
3 inch plastic core
Roll-shaped non-separated/semi-adhesive film without separator t 50±5ÿm×
length 300±5m Visually N/A
ÿ220mm
3 inch plastic core
have a function N/A
•The unwinding and rewinding mechanisms for each film are N/A
Weight dancer roll unit to manage lum tension Measuring instrument
25N
attach the
Document Control #:
Ver.1 Page: 40ÿ70
•The film after punching can be collected in roll form.

thing
•Please be careful when attaching the laminate and slightly adhesive film. Air bubble ÿ1mm or
There should be no bubbles and no phase shift. less Phase shift ±0.5mm
below caliper N/A
Crimping force 50ÿ
200N/100mm
•Lamination is done at the same position, but the hole machining part is fully covered.
Both the cut and top laminated sizes are kiss-cut.
thing
ÿ5.3 +0.1/0mm
60.9 +0/-0.1mm
60.9 +0/-0.1 Instrument N/A
16.2 +0/-0.1mm
×16.2 +0/-0.1mm
•For laminate punching, use the descending end of the pinnacle blade
Provide a positioning mechanism
pinnacle blade
Instrument N/A
0.01mm
resin pedestal
sim
*The adjustment allowance due to the floating gap is not included.

Take measures to prevent falling
•For the top lamination that is cut out on the temporary placement table, remove Charged ±100V or less at
The ionizer 50mm upstream from the Charge measurement N/A
shall have a self-diagnostic function. temporary placement position
•The top lamination is cut into one piece for the temporary table.
to be able to
•If the top laminate cannot be supplied to the temporary table within the Number of retries: 3
Inside the PLC
required tact, the number of retries must be as short as possible and the times Retry time: 2 N/A
timer
minimum number of times. times/within 5 seconds
Document Control #:
Ver.1 Page: 41ÿ70

•Set for continuous punching and cutting of laminate

have a tinging mode
•The top lamination stop position transferred to the temporary table is N/A
Provide a mechanism that is parallel to the reagent pack before welding. have a function Visually
and
•Film transport meandering adjustment mechanism different from the above mechanism N/A
have a function Visually
to provide
•Attach one top lamination transported to the temporary placement table

and provide a transfer machine to transport it to the reagent pack.
•In the transfer machine that transports the reagent pack, the top surface lamination
flow rate
Set thresholds where possible Visually N/A
0.01ÿ5.00L/min
•Alignment to ensure welding position accuracy of top lamination alignment

Araimen
A function is provided, and the aligned top surface lamination is used as a reagent. Adjustment unit N/A
information
welding to the pack X/Y: 0.01mm

csv file
XY resolution N/A
file export
0.01mm
•Welding position alignment amount (X, Y) on touch panel for n=900
to display a line graph in XY axis: ±0.30mm

Visually N/A
Display resolution
0.01mm
Document Control #:
Ver.1 Page: 42ÿ70
•There should be no liquid leakage when welding the top surface lamination to the reagent pack. value Welding position
The welding method is heat welding. deviation Welding center position ±
The figure below is the welding surface of the 0.5mm or less
top lamination. Red area: Fully welded without wrinkles, floats, or Offline decompression
foreign matter Pink area: All welded, but wrinkles of 1 mm3 or less, leak
slight floats, and foreign matter are acceptable -66.7kPa•5min
Yellow area: Whether or not welded does not matter No wrinkles, floats, or damage
*Temporary welding
Pressure reducer N/A
temperature at heat welding: 200
±2°C
Resolution 0.1ÿ
Main welding temperature: 205
±2°C
Resolution 0.1ÿ
•The welding temperature is displayed on the touch panel as a line graph. n=120min
letting minutes Range: 195 to
Also, display the alert threshold as a red line in the graph. 205ÿ Lower threshold Visually N/A
thing 197.5ÿ Upper threshold
202.5ÿ Display resolution 0.1ÿ
•In order to prevent misalignment before welding, provide a mechanism that
temporarily welds the top lamination on the top surface of the reagent pack have a function Visually N/A
when the top lamination is transferred to the reagent pack welding surface.
•Apply a voltage to the thermocouple using a calibrated measuring instrument. N/A

DC Signa
Capable of inspecting the condition of thermocouples have a function
le sauce
It must also have a connector to connect it to the measuring device.
•Use pinnacle blade (with Haneda sisponge) for lamination punching. Durability: N/A
-
More than 360,000 times
And touch panel display, settings can be changed Pinnacle blade, have a function Visually N/A
splash sponge, die (resin pedestal)
•The pinnacle blade replacement must have a reproducible structure and function. Visually N/A
Document Control #:
Ver.1 Page: 43ÿ70
To reflect

Alignment amount
*If the value exceeds the standard value three times in a row, an alert will be sent to the operator. Imaging N/A
Within ±0.5mm
system notification
Document Control #:
Ver.1 Page: 44ÿ70
[B-UNIT] ST-15 top lamination (sticking position inspection, welding condition inspection)
<Overview> Image of the position of the top lamination welded with ST-15
Inspect the welding condition with
(2) Inspect the welded state of the top lamination with an image
Top laminate welding position inspection
(3) Hand over the results of the imaging test to the next ST
(4) NG products are skipped without executing the post-process.
Eject to the outside of the system at ST-16
•It is possible to identify the welding state of the top lamination. value Welding position deviation
Inspection contents include welding position deviation, surface wrinkles, and air bubbles. From the welding center position
Scratches/damages, unwelded part detection (floating) ±0.5mm or less

Instrument N/A
Boundary between welding and non-welding of the reagent dispensing part No wrinkles, floats, damage
*If the value exceeds the standard value three times in a row, an alert will be sent to the operator. Boundary line OK/NG difference
notification Abnormal detection
Alignment amount csv file

N/A
Welding position deviation amount file export
XY resolution 1ÿm
•Welding position deviation amount (X, Y) is displayed on the touch panel as a polygonal line. for n=900
display the graph X/Y axis: ±0.3mm
Also, display the threshold value as a red line in the graph. Lower threshold -0.20mm
Visually N/A
Threshold upper limit +0.20mm
Display resolution
0.01mm
value Welding position deviation

•Welding position misalignment Imaging N/A
Within ±0.2mm
•Detection of surface wrinkles, scratches/damage, unwelded parts (floating) Contaminant sample 0.3mm2
Imaging N/A
Above is NG
•Air bubbles Air bubbles ÿ1mm or more

Imaging N/A
NG
•Boundary line between welding and non-welding of the reagent dispensing part Boundary OK/NG
Imaging N/A
*For NG products, we will present limited samples. difference detection
Document Control #:
Ver.1 Page: 45ÿ70
[B-UNIT] ST-16 Pack discharge (OK/NG/weighing sample selection/rotational transfer)
<Summary> NG products that have been determined to be OK/NG in each process and weighed samples are discharged from the system.
There are two systems for discharging outside the system: a) OK products/weighed samples, and b) NG products.
<Operation> (1) Reagent pack identifies either OK/NG product or weighing sample
ÿ If the product is OK, wait to send it to the next process.
ÿ In the case of NG items, randomly collect them at a designated location
ÿIn the case of weighing samples, dispense them to the designated place without changing the dispense order.
ÿ Each item is sorted and sent to the next process.
ÿ If the post-process cannot be used, it is discharged from the system while being sorted in intermediate discharge mode.
Discharge outside the system a): Dispense OK products and weighed samples to the same location
External discharge b): Randomly collect only NG products at a designated location
•All the detected NG products are discarded and are definitely OK products.
OK/NG products, weighing
and weighed samples and sorted and randomly placed in place Visually N/A
Sample and 3 sorting
to be collected
•All the detected weighing samples are surely OK products.

OK/NG products, weighing
Sort out NG products, and move the delivery order back and forth Visually N/A
Sample and 3 sorting
to be paid out without
•Dispense weighing samples for each 100 OK products.

OK99 ÿ 1 weighing sample ÿ OK99 … •Measure the quantity of the
dispensed weighing sample and touch it.

display on the panel
•Provide an intermediate payout mode
Discharge to the outside of the system a): Place OK products and weighed samples in the same place have a function
pay out *Payout is a)b) at the same time Visually N/A
Eject outside the system b): Only NG products are randomly placed in a predetermined place carried out on
collect it
N/A N/A N/A N/A

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Ver.1 Page: 46ÿ70
7-4. Line Details (Reagent Pack Assy Assembly Process)
[C-UNIT] ST-17 Temporary storage
<Action> N/A
N/A Visually N/A
N/A N/A N/A N/A
[C-UNIT] ST-18 temporary storage
<Action> N/A
N/A Visually N/A
N/A N/A N/A N/A

Document Control #:
Ver.1 Page: 47ÿ70
[C-UNIT] ST-19 Chip insertion (Chip insertion machine/Chip orientation inspection)
<Overview> Chips taken out one by one from the chip transport tray
insert into reagent pack
<Operation> (1) Fix the reagent pack and determine the chip insertion position
ÿReceive chips one by one from ST-19b
ÿ Temporarily place the chip so that the convex part on the surface faces the top lamination side
do
ÿThe removed Chip is inserted into the reagent pack.
position
ÿ Insert it to the specified position
The insertion position is the concave edge (yellow line) on the Chip side,
Until it crosses the convex edge (red line) on the reagent pack side
Push in (Refer to upper right figure)
•Do not scratch or damage the chip when transporting or inserting it. No scratches or damage Measuring instrument N/A
•When transporting the chip by suction, remove the flow path. •Once No scratches or damage Measuring instrument N/A
the chip is adsorbed, hold it until the transport is completed.

thing
•Continuous supply of chips within the requested takt Visually N/A
•There is a transport orientation discrimination or mechanism before inserting the chip.

thing
•Before inserting the chip, check that the two protrusions on the chip surface are
being able to detect something

If pre-insertion detection is difficult
Allowed even during insertion
•Insert until the specified position. reagent pack and
Each Chip Visually N/A
Up to uneven parts
•The amount of inserted material used can be monitored.

amount to use Visually N/A
Current usage amount, cumulative usage amount, additional amount (manual addition)
•Front/back detection before chip insertion Chip surface convexity

Sensor detection N/A
OK on top laminated side
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[C-UNIT] ST-19b Chip loading machine (loading hand, chip orientation inspection, stack unwinding mechanism)
<Summary> Insert the chip transport tray containing the chips into the equipment,
Transport chips one by one from the chip transport tray to the insertion machine
let
<Operation> ÿ Set the chip transport tray on the special tray of the equipment
ÿSet the special tray in the tiered part of the equipment (20 tiers)
ÿ Remove the stacked special trays one by one.
ÿPick the chips one by one from the dedicated tray separated by tiers.
Take out and transport to ST-19
ÿ Empty special trays are temporarily collected at the stacking section.

Chip insertion direction
be done
•The number of dedicated trays to be supplied to the stacking section and stacking section is determined by each Equipment maximum
Visually N/A
Must be 20 pieces Number of inputs: 20 pieces
•Even if the equipment is in automatic operation, special trays cannot be taken out.
Possible to insert
Covers and sensors are provided to ensure safe loading and unloading. have a function Visually N/A
Install sensors and switches to ensure the safety of workers.
thing
•Alarm to the worker when the special tray becomes low

have a function
to notify Visually N/A
2 remaining
If the worker cancels the alarm, the notification will stop.
•When the dedicated tray becomes empty, an alarm is sent to the operator.
to know have a function Visually N/A
If the worker cancels the alarm, the notification will stop
•When the special tray becomes full, an alarm is sent to the operator.
to notify
If the worker cancels the alarm, the notification will stop have a function Visually N/A
When the special tray is full, automatic operation will be stopped.
thing
•It is possible to determine the chip insertion direction before inserting the chip. Visually N/A
•Detection of insertion direction before chip insertion Chip wide part

OK at beginning of insertion
Document Control #:
Ver.1 Page: 49/70
<Action> N/A
N/A Visually N/A
N/A N/A N/A N/A

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[C-UNIT] ST-21 Cap insertion (insertion machine/parts feeder P/F)
<Summary> Insert Cap into equipment and start automatic continuous operation.
enable
<Operation> ÿ Fix the reagent pack and determine the Cap insertion position.
ÿThe worker supplies Cap to the hopper or P/F.

cap
ÿOnly when equipment command is requested, Cap is set in P/F.
Transport to designated position
ÿCaps are intermittently put into the equipment one by one.
ÿThe caps cut out one by one are attached to the reagent pack.
Position the insertion with
ÿ Insert it to the designated position
Until the part indicated by the red circle in the diagram on the right is mated.
Push Cap into Chip (Refer to upper right figure)
•The operator must be able to put Cap into the P/F by hand. Functional Visual inspection N/A
•Cap should be supplied into the equipment using P/ Functional Supply Visual inspection N/A
F. •A hopper for intermittent supply should be 1 hour Measuring instrument N/A
provided. •When the hopper for intermittent supply becomes low, the operator
have a function
Alarm notification to Visually N/A
About 100 (±50)
•P/F control must be via PLC

And individual control is NG
•The supply of Cap is uninterrupted. within the requested takt Visually N/A
•Before inserting the Cap, check the direction of Cap insertion or if the mechanism is
something that is
•Insert until the specified position. Chips and Caps
each Visually N/A
to mating part
•The amount of inserted material used can be monitored.

amount to use Visually N/A
Current usage amount, cumulative usage amount, additional amount (manual addition)
•Detection of insertion direction before Cap insertion Cap mating part

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Ver.1 Page: 51/70
<Action> N/A
N/A Visually N/A
N/A N/A N/A N/A
[C-UNIT] ST-23 Cap inspection (Cap presence/absence inspection/Cap orientation inspection)
<Summary> Insertion status and orientation of Cap inserted in ST-21
Inspect the mating condition using images
ÿ Image of the fitted state of the Cap from the top laminated side
inspect
(3) NG products are skipped without executing the post-process,
Discharge outside the system using ST-27
Requirements Specified value Verification method Remarks
•It is possible to identify the fitted state of the cap. Presence/absence determination
The inspection contents include whether or not the cap is inserted, insertion direction, and mating position. Orientation determination Visually N/A
Mating position
•Ability to log image test results to PLC Presence/absence determination result
csv file
Orientation determination result N/A
file export
Mating position result
•Provide an intermediate payout mode

have a function
Discharge outside the system a): Discharge OK products
*Payout is a)b) at the same time Visually N/A
Eject outside the system b): Only NG products are randomly placed in a predetermined place
carried out on
collect it
•Detection of presence or absence of cap insertion value Presence/absence determination Image inspection N/A
•Inspection of Cap insertion direction Cap mating part

Imaging N/A
•Cap fitting position inspection Chips and Caps
each Imaging N/A
to mating part
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Ver.1 Page: 52/70
7-5. Line details (reagent pack labeling/alignment machine process)
[D-UNIT] ST-24 temporary storage
<Action> N/A
N/A Visually N/A
N/A N/A N/A N/A
[D-UNIT] ST-25 Temporary label pasting (labeler)
<Summary> DataMatrix code and item name on plain label
Print it out and temporarily attach it to the designated position on the reagent pack.
do
<Operation> ÿ Fix the reagent pack and determine the attachment position
Labeling position
(2) Print one label
ÿAttach one label to the reagent pack.
Rolled label (with front and back sides) roll length 300m Visually N/A
Base material + adhesive layer, separation paper 3 inch plastic core
•Be able to print on the specified label label size
9±0.1mm× Instrument N/A
18±0.1mm
-
•There are no unattached labels Visually N/A
•CODE128 barcode written on the manufacturing instructions
Read with barcode reader and import into PLC have a function Visually N/A
to memorize
•Production instruction information obtained from CODE128 is applied to each process.
to reflect
Display on touch panel have a function Visually N/A
Data transfer to label printer
ST-27 Data transfer to image inspection
•Print quality must be ensured
Recommended printer: LR4NX (manufactured by SATO) ISO/IEC15415

Instrument N/A
Recommended ink ribbon: WB1008010/R235B/W39.5 Grade C or higher
×L300M (black resin type)

Document Control #:
Ver.1 Page: 53/70
•Print contents are as follows.
DataMatrix, item name (HbA1c), Lot number
The area around the DataMatrix is a quiet area of 2 or more cells.
Printing should not
extend beyond the label.
Measuring instrument with functions N/A
product label
Lot Info Label (Label for Cleaning Cartridge)
•DataMatrix standards are as follows.
Code standard: ECC200
Symbol size: 18 x 18 cells Data cell

Measuring instrument with functions N/A
size: 16 x 16 cells Quality: ISO / IEC15415
grade C or higher
Code content: [End of book] Refer to Lot information label
•One printed label can be attached to the reagent pack.
thing
Attachment size
A: 0.5 to 2.0mm
Instrument N/A
B: 0.5 to 3.0mm
C: ±1.0°
Document Control #:
Ver.1 Page: 54/70
•The label pasting position can be adjusted using the fixed part of the printer body.
Adjustment dimension allowance
what you can do

A: -5.0 to +5.0mm
B: -5.0 to +5.0mm
Instrument N/A
C: -2.5 to +2.5°
Resolution 0.1mm•
0.1°
N/A N/A N/A N/A

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[D-UNIT] ST-26 Label pasting (pressing mechanism)
<Summary> Attach the temporarily attached label permanently.
<Operation> ÿ Fix the reagent pack and determine the attachment position
ÿ Move the roller while pressing it against the entire surface of the label.
(3) After pressing onto the label, remove the roller from the reagent pack.
to evacuate
•Attach the reagent pack to the label without the following: floating label
thing •Peeling
Label lifting/peeling, misalignment, scratches/damage, stains Bubble ÿ1.0mm
The crimping force at the time of application can be changed by air pressure drive. Below (reference value)
Pasting dimensions
A: 0.5 to 2.0mm
B: 0.5~3.0mm Visually N/A
C: ±1.0°
Scratches, damage, dirt
Label after printing
state maintenance
Crimping force 0ÿ
100N/9mm width
•The number of times the label is pressed can be set arbitrarily In-process inspection requirements Visually N/A
Standard value Pass/Fail Judgment Notes
N/A N/A N/A N/A

Document Control #:
Ver.1 Page: 56ÿ70
[D-UNIT] ST-27 Label inspection (label existence inspection, label orientation inspection, OK/Rework/NG sorting) <Overview>
Performs image inspection of label printing status. The used
reagent pack is discharged from the system as an NG product.
Only reagent packs judged as NG in the process of ST-27 are discharged outside the system as Rework products There are two
systems for discharge outside the system: a) NG products and b) Rework products.
ÿ Inspect the printing status of the label using images
ÿ Determine whether the reagent pack is OK or Reworked. ÿ If it is OK,
arrange it on the forming tray in ST-27b. ÿ If it is Reworked, arrange it in the
specified location. ÿIn the case of NG products, discharge them randomly to a predetermined
location outside the system.
•Label pasting condition can be identified.Inspection Attachment position misalignment is below
contents include misalignment of pasting position, misalignment of A: Within 0.5 mm or
print area, scratches, damage, and stains, DataMatrix grade judgment, 2.0 mm or more B:
and printing certification (item name/Lot Within 0.5 mm or 3.0
number).For dimension A, within the full width of the label. Measure the mm or more C: ±1° or
maximum and minimum values at and make a pass/fail judgment. *If more Printing should
not protrude from

the value exceeds the standard value three times in a row, an alert will be sent to the operator.
notification the label No scratches

Visually N/A
or damage Dirt of 1
mm2 or more
NG
DataMatrix gray
Code D and below are NG Print
collation with manufacturing
instruction information
•If the image test fails, please place it in a designated place.

Arrange them and discharge them outside the system as rework products.
•Ability to log image test results to PLC Adhesion position deviation
presence/absence, printing range
deviation presence/absence,
csv file
scratches/damage presence/ N/A
file export
absence, DataMatrix grade
judgment results, print authentication (item name/
Lot number)
Document Control #:
Ver.1 Page: 57/70
•The amount of deviation in the pasting position (X, Y, ÿ) is determined by the amount of bending on the touch panel. value n=900 pieces
To display a line graph.Also, to X/Y: ±5mm
display the threshold value as a red line in the graph. A:
Threshold lower limit -0.5mm
Threshold upper limit +2.0mm
B:
Lower threshold -0.5mm Visually N/A
Upper threshold +3.0mm
C:
Threshold lower limit
-1.0° Threshold upper
limit +1.0° Display resolution
0.1mm•0.1°
•Attachment position misalignment The following shall be
For dimension A, measure the maximum and minimum values within the full NG A: Within 0.5 mm
width of the label and make a pass/fail judgment. or 2.0 mm or more B:

Imaging N/A
Within 0.5 mm or 3.0
mm or more C: ±1°
or more Print
•Print range deviation should not protrude

Imaging N/A
from the label NG Dirt
• Scratches, damage, dirt condition Contaminant
sample 1.0mm2 or
more is NG
Imaging N/A
•DataMatrix grade judgment Grade D and below

Imaging N/A
is no good
•Print authentication (item name/Lot number) Print verification discrepancy with
manufacturing instruction information

Imaging N/A
Less than 80% is NG
with the OCR function

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[D-UNIT] ST-27b Aligner (discharge alignment hand/stacking/destacking) <Overview> Aligns
reagent packs that have been completed as OK products onto dedicated trays <Operation> (1) Loading
section for empty dedicated trays set to

alignment tray
ÿ Remove one special tray from the input section,
Cut out a special tray
ÿ Arrange the OK items on the special tray cut out.

stacking section stepped part
ÿThe special tray cut out is
full of OK items.
As soon as it becomes , move it to the discharge
section. ÿ Stack one dedicated tray at the position of the discharge section.
discharge part Throwing part
do
ÿ Notify the operator when the discharge section is full
•The number of dedicated trays supplied to the input section and discharge section is 20 each.
In addition, the
number of dedicated trays temporarily supplied to the unstacking and
stacking sections shall be 20 each. As an alignment mechanism, the
* We use our weights for the outer frame (material handling) and special equipment can Visually N/A
trays for the inner frame. accommodate up to 60 sheets.
revenge
Banju
•Special tray contains 50 reagent packs per tray
All the reagent packs must be stored without

falling out. Also, the shape must allow stacking without damage to the
reagent packs and without collapsing.
•Special trays (blister packs) used during production must be

Procurement quantity
procured by your company. Visually N/A
500 trays
*The weights used by our company are provided by us.
•The special tray feeding method to the input section and output section is manual.
It is possible to freely enter and exit the warehouse using a trolley. have a function Visually N/A
*Please select a hand cart from commercially available products.
- Covers and sensors are installed to enable safe entry and exit of hand
carts even when the equipment is operating automatically.
Ensure the safety of workers by installing the have a function Visually N/A
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•When loading and unloading the push cart, unstack or stack it.
Safety features have been installed to prevent bodily interference and malfunctions. have a function Visually N/A
to put
- An alarm can be sent to the operator when the dedicated tray is low.
and have a function

Visually N/A
If the worker cancels the alarm, the notification will stop. Only 2 left
* Only when the special tray remaining in the loading section and during untiering is empty.
•When the dedicated tray is empty, an alarm is sent to the operator.
Automatic operation will stop when the dedicated tray is empty.
thing have a function Visually N/A
*For both the loading section and the discharging section
•An alarm is sent to the operator when the special tray is almost full.
thing have a function

Visually N/A
If the worker cancels the alarm, the notification will stop. Near full 18 sheets
*Only when the discharge section is full and the stacking section is close to full.
•When the special tray is full, an alarm can be sent to the operator.
and

When the special tray is full, automatic operation will be stopped.
thing
*Both discharge section and stacking section
N/A N/A N/A N/A

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7-6. Line details (common to units/operation panel/control panel/others)
[Safety related]
<Summary> Items related to safety within this specified equipment are described.
•The standard height for installing the emergency stop button is from the center of the button. Installation height
Instrument N/A
1500mm to the floor 1400-1600mm
•Emergency stop is called EMS (Emergency stop) and stops on the spot.
to be
*For air equipment, it is possible even when the operation is complete. have a function Visually N/A
*Please use a stopping method that takes safety into consideration for the lifting section.
Hiring
- Manufacturers are notified of potential hazards, hazardous conditions and hazardous events. ISO13849-1 target area
clearly in all driving modes and do not cause any harm. Category 2 presented N/A
Must have safety functions (required safety functions) and mechanisms comply with Separate discussion
•Alarm sounds when equipment trouble occurs alarm specifications

75dB or more N/A
Confirmation of the description of
•In case of an emergency stop, immediately after ensuring and confirming safety,
If the abnormality is removed, recovery is possible in any case. Operation check with function N/A
thing
•Automatically controlled by PLC in any case when an error occurs
The operating program will be stopped in a state where it can be restored. PLC internal with function N/A
being
•The power or air source is interrupted in the lifting section.
If there is a risk of falling, maintenance have a function Visually N/A
Occasionally have a fall prevention jig attachment or function
•In-flight lighting inside the equipment must be at least 700 lx (lux).
thing at 1m under illumination

Luminometer N/A
The number of installations is based on the standard lighting installation interval of 2m, and illumination
Installation should take into account the placement of the equipment.
N/A N/A N/A N/A

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[Monitoring/Management
Related] <Summary> Items related to the management of operation and historical status within this specification equipment are described.
* There is some overlap with the content described in each ST.
•To count and log all abnormal occurrences and abnormal cancellation value 200 past operation check
history that occurred in the equipment. histories * csv file N/A
ST name, error details, date and time of occurrence Overwritten and erased View
•All information related to this equipment can be displayed on the screen.
Operation details, setting details, operating status, alarm/error history (place/
time/content), JOG function, hourly production

High graph, number of inputs, number of OKs, number of NGs at each ST
Total number of NGs, number of discharges outside the system (both manual and automatic)
*Display content will be discussed separately.
•Equipment processes related to product quality (temperature, welding position deviation, etc.)
(volume, correction value, flow rate, pressure, etc.) is graphed (line graph, have a function Visually N/A
scatter diagram) and displayed on the operation panel.
For each punching ST, the monitoring contents of replacement frequency should
be displayed on the touch panel Operation check with function N/A
Cumulative number of punchings since each replacement
Set the scheduled number of punchings for each replacement guide
•Displaying the monitoring contents of dispensing on the touch panel

Operation check with function N/A
Estimated number of times to finish dispensation
•Turning the contents of monitoring of the replacement frequency of the top surface lamination sheet
to be displayed on the touch panel

Cumulative number of welds after
replacement Scheduled number of welds for replacement

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•It is possible to monitor the amount of material used
<measurement management during automatic operation>
Amount used on the day: Total amount used per
day Accumulated amount used: Total amount used per 1 lot
of materials Individual input to be reflected in measurement management
> Fixed value usage amount: Usage amount when replacing
materials Usage amount ±5m Visually N/A
After inputting, usage information is automatically reflected in the current day/
accumulated usage amount.
•Sensors and controllers with set values and thresholds
La can be changed from the operation panel Operation check with function N/A
*Applicable equipment will be examined after separate consultation.
- Make a list of setting values and threshold values. operation check
Also, it is possible to export to csv data. have a function csv file N/A
View
•The screen size for image inspection shall be 17 inches.
In addition, the screen has a movable arm attached to the front of the equipment. Operation check with function N/A
It should be possible to move horizontally 180 degrees or more relative to the standard and visually check.
•The number of screens for image inspection is the same as the number of controllers.
to be
*Basically, it should be installed within 2m from the image inspection ST.
Negotiable if necessary
Document Control #:
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[Maintenance/maintenance related]
<Summary> Items related to operation within this specification equipment and maintenance and management of product quality are described.
* There is some overlap with the content described in each ST.
•Equipment that requires replacement of consumables and disassembly for cleaning (sensors,
of special tools
(solenoid valves, filters, etc.) can be removed separately for maintenance. operation verification N/A
Usage prohibited
ensure the nonce size
•A table that shows normal driving, abnormal dangers, etc. just by visual inspection Operation board
Visual confirmation N/A
to show Signal tower
•Openings on the flow line of product materials are material

Operation confirmation N/A
Close it to prevent it from getting in. No gap
•Where adjustments are required during production, place them on a tool shelf or
-
Provide a tool storage area.
•AC100V/5A service outlet inside the equipment
to provide 2 outlets Visual confirmation N/A
*The installation location will be discussed separately.
•The primary air supply port is equipped with a regulator, filter, -

Provide a pressure switch with output and a quick exhaust valve.
•The drop in air pressure on the primary and secondary sides is caused by the supply pressure setting.
If there is a fluctuation of 0.05MPa or more from the fixed value, Variation tolerance
operation verification N/A
Mounting the accumulator tank Set value ±0.05MPa
*Excludes air pressure fluctuations caused by the supplier.
•When the primary air pressure drops below 0.35MPa, Air pressure drop
Alarm after cycle stop Stop at 0.35MPa
•When using a ring blower as a vacuum supply source,
-
Must be easy to replace (estimated replacement time: 10 min) Visual confirmation N/A
Installing an exhaust filter to ensure cleanliness
•Hot cleaning air gun that can be routed throughout the equipment.
Operation check at 2 or more locations within the facility N/A
Install using a bracket or hook.
•Ensure a dedicated power source for the ionizer.
-
*OA tap (with individual switch and surge suppressor) Visual confirmation N/A
Adoptable
•The air cylinder should be equipped with an air cushion. none -

If so, consider installing a shock absorber.
•The air circuit speed controller is a push rod.
-
A scale type is used where flow rate monitoring is required. Visual confirmation N/A
to do
Document Control #:
Ver.1 Page: 64ÿ70
•Apply or remove screw locking agent to all fasteners in the equipment.

-
or have that mechanism.
•Equipped with an FFU on the top of the equipment, and a cleanliness class of 100,000 Cleanliness 100,000 Particle measurement
N/A
Ensure positive pressure inside the device Positive pressure inside equipment positive pressure confirmation
•Each gauge (regardless of analog or digital) has

Displayed in SI units Visual confirmation N/A
Clearly display fixed values, upper and lower limits, and threshold values.
•Cutting duct design and construction shall be as follows:
1) The duct storage volume shall be 80% or less.
2) If there is a small amount of wiring or plumbing tubes, arrange them.
3) Take noise countermeasures for power lines and communication lines.
* Installing a noise filter on the secondary side of the main breaker storage volume
Visual confirmation
It is also possible to adopt a shield type cable for the communication line. 80% or less N/A
statement
Noise countermeasure
<Reference example>
•Plastic cable design and construction shall be as follows.
1) The duct storage volume shall be less than the design value of the selected product.
Approximate storage volume 60-70% or less
2) The wiring inside the plastic cable shall be a flexible cable.
3) Take noise countermeasures for power lines and communication lines.

storage volume
*Install a noise filter on the secondary side of the main breaker Visual confirmation
Below the selected product design value N/A
It is also possible to adopt a shield type cable for the communication line. statement of account
Noise countermeasure
<Reference example>
N/A N/A N/A N/A

Document Control #:
Ver.1 Page: 65ÿ70
[Operation board]
<Overview> A touch panel is used to control all information such as equipment operation, settings, and status display.
•All operations and variable settings related to this equipment are performed.
to get
•Provide a cycle stop button to stop the equipment.

*Pause function by pressing the button is not possible.
•The operation panel uses a touch panel (12 inches or more)
thing have a function Visually N/A
*The screen size of the sub touch panel is not limited to this.
•The operation panel and each display are affected by ambient light.
be visible without
•The installation height of the control panel is from the floor to the center of the screen. Installation height
Instrument N/A
be 1500mm 1400-1600mm
•Display content on the control panel can be written in both Japanese and English, or can be switched between Japanese and English.

What you can do
N/A N/A N/A N/A
[control panel]
<Summary> Electric control equipment, electrical equipment, and electrical parts for electrically controlling the machines related to this facility are stored.
show something
•The size should be designed with space saving in mind. •The Door opening angle 90 degrees or more Visual inspection N/A
number of installed units should be kept to a minimum, without affecting the indoor layout.
Cannot be installed on the floor Visually inspected N/A
not to give
•If there are multiple control panels, indicate the name of the panel. N/A
on the worker flow line

Visually N/A
What not to do Wiring not possible
N/A N/A N/A N/A

Document Control #:
Ver.1 Page: 66ÿ70
7-7. Others
[Supplies]
<Summary> When manufacturing this equipment, we will provide the necessary parts used for test runs and performance verification free of charge.
item Content Remarks quantity
•Reagent pack Drawing: 62-25164A, 62-27415) N/A
·filter Model: C045A (Advantech Toyo) Model: N/A
•Hydrophilic film MF-80K (Japan Vilene) Drawing: N/A
64-25299 N/A
•Electrode •Laminate film Model: (outer surface) GX-PF (letterpress printing)

N/A
bottom/top (Inside) HC-OP (Mitsui Chemicals Tohcello)
•Slightly adhesive film model: EM-L60 (Higashiyama Film) •Reagent N/A
solution 1/2 •Cap Specifications: R1 Reagent, R2 N/A
Reagent Drawing: 63-26115B N/A
•Chip A, B Drawing: KK131001-B24, KK131001-C17 N/A
Model: Yupo #80 (Lintec)

·label N/A
ÿPAT1 8K (Lintec), Sepa mount
Product name: Banju D Product number: 201103 Must be returned
•Banju•Color sample (Sanko) Munsell: 2.5Y8.5/2 (Nikko: H22-85D) Must be returned

Document Control #:
Ver.1 Page: 67ÿ70
8. Deliverables
Deliverables
[deliverables] <Overview> Shows the information and handling of this equipment as a completed document.
•The language used in deliverables must be the one on the right. ÿ Japanese ÿ
And, it must be reflected in all deliverables. *Words that cannot English ÿ
be written in Japanese are not included. *Submissions categorized Chinese ÿ Visually N/A
by language are also acceptable. Other
languages ÿ )
•Please submit two copies of the mechanical drawing. Overall assembly
In addition, all installation relationships of parts and equipment purchased diagram Each ST assembly
must be confirmed. diagram Assembly Visually N/A
exploded diagram *Only necessary items
during maintenance Overall
•Two copies of electrical drawings must be diagram of the operation
submitted. In addition, all installation relationships of parts and equipment panel Equipment layout diagram of
purchased must be confirmed. the operation panel Overall

Visually N/A
diagram of the control panel
Equipment layout
diagram of the control
•Please submit two copies of the parts list. panel Wiring system diagram
Wiring diagram Visually N/A
<Mechanical/Electrical> Production parts list Equipment Purchase list
•Submit one copy of each program used in the facility. It is mandatory to PLCs
include comments that can be entered so that the program content can be touch panel CD-ROM
understood. Image or equivalent N/A
inspection Various motors and electric things
actuator
•Please submit two copies of the parameter table. <Mechanical/Electrical>

Visually N/A
Parameter table
•Please submit two copies of the consumables list.
In addition, if the manufactured product is the object, attach the parts diagram <Mechanical/Electrical>
Visually N/A
about Consumables list
In addition, the frequency of replacement is one week or more.

Document Control #:
Ver.1 Page: 68/70
•Please submit two copies of the recommended spare parts list.
In addition, if the manufactured product is the object, attach the parts diagram <Mechanical/Electrical>
Visually N/A
About Spare parts recommended list
Applicable to custom-made products with a delivery time of one week or more
•Submit two copies of instruction manuals for purchased equipment <Mechanical/Electrical>

Visually N/A
Issued by the manufacturer
•Please submit two copies of the operation manual for this equipment. paper
Visually N/A
Also, please describe how to deal with the problem. electronic data
•Submit two copies of the maintenance inspection list.

space
Maintenance includes routine, periodic (1 week, 1 month, 3 months, 6 months, Visually N/A
electronic data
1 year) frequency of inspection
•Please submit two copies of the time chart for each ST.
paper
Equipment performance (actual production capacity and equipment design ability) Visually N/A
electronic data
Assume that it is shown as one cycle.
N/A N/A N/A N/A
9. Warranty
guarantee
Scope of application The requirements for the functions and performance required of the production equipment for the products covered by this specification are met.
Items not included, and defects.
The determination of applicability will be made after separate discussions between the two companies.
Content Equipment related, excluding manufacturer's warranty.
For defects that occur during the warranty period and are not due to our responsibility, the consignee will promptly and free of charge
repair or replace any
period One year after completion of acceptance inspection.
However, if a defect clearly occurs due to the equipment manufacturer, the contractor will not be liable even after the warranty period.
Scope of responsibility.
Document Control #:
Ver.1 Page: 69/70
[End 1] Lot information label
[DataMatrix code example] 1CE119B1A1A20B7509961075
ÿbreakdownÿ
ÿ ÿ ÿÿ
ÿ ÿ
Lot No. use
Current value Lot calibration curve (ÿIFCC)
Deadline
product identification
Manufacturing information
addition No. slice
Batch year month uA slope slice
information Destination manufacturing manufacturing Through manufacturing manufacturing sign
item
earth Year Month Product number Country place
1 CE1 1 9 B 1 A 1 A 20B 75 0996 1 075
(1) Additional information: 1-digit number. Set to "1" unless otherwise specified.
ÿLot No.: A 9-digit character string consisting of a product identification number and manufacturing information.
Manufacturing refers to preparing a reagent solution. Details follow the table below.
product identification number CE11: The Lab 001 A1C HD (JPN)
(For each destination specification CE12: The Lab 001 A1C HD (US)
fixed) CE13ÿThe Lab 001 A1C HD (INT-IVD,INT,IVDR)
CE14ÿThe Lab 001 A1C HD (CHN)
Manufacture year End of the Western calendar 0~9
manufacturing month A~M (excluding I)
A January D April G July K October
B February E. May H August L. November
C March F June J September M December
Manufacturing serial number 0~9 *Given in the order of 1,2,3,4,5,6,7,8,9,0
* Granted for each manufacturing (prepared solution) in the same manufacturing country, manufacturing location, and relevant year and month
Country of A (Japan)
manufacture Place of manufacture 1 (Arkray Factory Konan Factory)
ÿBatch No. : 1-digit alphabet. Set up for manufacturing control.
The definition of batch division should be set as appropriate according to the actual situation at the manufacturing site.
(4) Expiration date: Consists of year (2 digits, last 2 digits of AD) and month (1 digit of alphabet).
Month notation follows the <Month of manufacture> table above. The expiration date is the last day of the month.
ÿ Current value : Two-digit number. Indicates the constant current setting value (unit: ÿA) during electrophoresis.
ÿLot calibration curve: 8-digit number. This is a conversion formula (primary formula) from measured raw values to IFCC values.
The slope is interpreted to 3 decimal places and the intercept to 1 decimal place.
As for the sign, 0 is - (minus) and 1 is + (plus).
*Conversion from IFCC value to NGSP value and from NGSP value to eAG is performed using the values stored in the device.
Use the master conversion formula.

Document Control #:
Ver.1 Page: 70/70
[End 2] Lot Info Label (Label for Cleaning Cartridge)
*1 The item name should be “001 Cleaner” and divided into two lines.
*2 DataMatrix must comply with the following.
Code standard : ECC200
Symbol size: 18×18 cells
Data cell size: 16×16 cells
:ISO/IEC15415 grade C or higher
Quality Code :MANIFOLDCLEANING11111111
Contents *3 The print quality of the item name is irrelevant.
End
that's all

【要求仕様書】RT- (00000) -RSM-078 ver.1 - 試薬パック組立装置（K2） - 20230719

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【要求仕様書】RT- (00000) -RSM-078 ver.1 - 試薬パック組立装置（K2） - 20230719

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Document Control #/Document control number B-FdAAA-17002-02 Ver.7

Equipment and Jig Requirements Specifications

Equipment (jig) name

International Manufacturing & Engineering Services Co., Ltd. Imes Co.,

ARKRAY Factory Inc.

Ver. Approval date Approved by Checked by Created by Revising dept.

ARKRAY Factory Inc.

Document Control#/Document Control Number B-FdAAA-17002-02 Ver.7

Revision History Revision History

Approval date Revised section Revised content

Document Control #/Document control number B-FdAAA-17002-02 Ver.7

Consignment side: Equipment supplier who accepted this specification

To secure and adapt.

The corresponding range.

RT-(00000)-RSM-004 v.2_Equipment requirements specifications (main equipment/common)

RT-(00000)-RSM-005 v.2_Equipment requirements specifications (main equipment/machines)

RT-(00000)-RSM-006 v.2_Equipment requirements specifications (main equipment/electrical equipment)

RT-(00000)-RSM-007 v.2_Equipment requirements specifications (main equipment/equipment used)

We will discuss this separately and work together.

Both companies will hold discussions.

Document Control #/Document control number B-FdAAA-17002-02 Ver.7

4. Information regarding delivery date and acceptance inspection

4-1. About delivery date and

acceptance inspection 10 months after finalizing specifications

Delivery date Acceptance inspection Delivery place

Reagent Building 1F Workroom 2 Acceptance inspection conditions

ÿEducation and training regarding operating explanations ÿSubmission of deliverables

4-2. Transport/packaging form and scope of work

Transport form ÿ Land transport ÿ Sea transport ÿ Air

ÿ Opened wooden box ÿ Steel packaging ÿ Barrier packaging Delivery

Material processing ÿ Your company ÿ Our company

ÿFAS ÿFOB ÿCFR ÿCIF

Document Control #/Document control number B-FdAAA-17002-02 Ver.7

5-1ÿ Common specifications

Production environment temperature 18-26ÿ

ÿNo management ÿManagement Class 10,000

Cleanliness Operating time 24 hours continuous

ÿFactory side ÿEquipment side

Piping Compressed air (primary side) color:-

SGP-W Compressed air (inside machine) Color: black

Urethane tube Vacuum Urethane tube Color: transparent blue

Primary side construction ÿYour company ÿOur company

power supply Power supply (primary side) ÿAC100Vÿ1 ÿAC200Vÿ3

Power supply (power) ÿAC100Vÿ1 ÿAC200Vÿ3

Power supply (control) ÿDC12V ÿDC24V ÿOther (Primary side connection )

type ÿBreaker receiver ÿTerminal block receiver

Primary side construction ÿ Your company ÿ Our company

Frequency ÿ50Hz ÿ60Hz ÿ50•60Hz

(Steel-based) Film thickness 30ÿm or more

Black baked paint Black matte Film thickness 30ÿm or more

General Plating Bright Chromate (Unichrome)

Precision plating required Electroless nickel plating Film thickness 5 to 10 ÿm

exterior Surface treatment General coating White alumite

(Aluminum-based) Black coating Black alumite (matte)

Hardness coating White hard alumite

Abrasion resistant coating TAFRAM

(SUS type) Decorative treatment ÿElectrolytic polishing ÿ#400 ÿHL

Connection with other equipment ÿNo ÿYes