Hướng dẫn sử dụng máy phân

tích huyết học

Diatron Aquila

User Manual
Version D

1097 Táblás utca 39.

Budapest, Hungary Tel: +36 1 4369800
Fax: +36 1 4369809
www.diatron.com
 Mô tả máy phân tích Aquila
Mặt trước của máy phân tích

3
2

(1): Màn hình cảm ứng kích thước ”(1280x800) là giao diện người dùng chính của máy phân tích
(2): Công tắc chờ của bảng điều khiển phía trước. Vòng tròn màu được chiếu sáng xung quanh cho biết
trạng thái của máy phân tích ‘Aquila ’là:

MÀU SẮC HOẠT ĐỘNG Ý NGHĨA

Blue Đèn tròn đầy đủ, cường độ cao liên tục Thiết bị sẵn sàng đo (mở)
Blue Toàn bộ vòng tròn nhấp nháy ở cường độ thấp Thiết bị ở trạng thái chờ
BLUE Vòng cung của đèn nhảy loạn Quá trình đang diễn ra.
RED Vòng cung của đèn nhảy loạn Lỗi mức thấp, hết pin
(3) Cửa mẫu. Các ống mẫu được đặt vào vị trí để mẫu (Bộ chuyển đổi lọ có sẵn cho Aquila) cho lọ đóng
hoặc lọ mở. Cửa lấy mẫu – cùng với ống – được đóng lại bằng phần mềm, trong khi nó định vị lọ bên
trong máy để hút mẫu. Tính năng an toàn này bảo vệ người vận hành khỏi vô tình tiếp xúc với kim hút
trong quá trình xử lý mẫu. Không thể mở được cửa mẫu ngẫu nhiên.

(4) Cửa khoang chứa hóa chất. Đậy nắp trong quá trình vận hành.

(5) 2 chiếc cổng giao tiếp USB cho thiết bị ngoại vi (Xem thêm trong Thiết bị ngoại vi bên ngoài)
 Mặt sau của Máy phân tích

4
2

5
6

3
7

Nắp sau Aquila

(1) Đầu vào nguồn. Loại DIN 4pin, đầu vào là 24V / 3,75 A, nguồn cung cấp bên ngoài phải được kết
nối tại đây
(2) Công tắc nguồn. Công tắc này tắt mọi điện áp đến (24V) và nguồn pin bên trong trên máy phân tích
(3) Cổng loa
(4) Cửa che khoang chứa thuốc thử nhìn từ phía sau
(5) Đầu nối Ethernet RJ45 cho kết nối mạng và LIS
(6) 4x đầu nối USB 2.0 cho kết nối ngoại vi USB chung
(7) Nhãn sản phẩm

Nhãn nhận dạng sản phẩm

2 1

3
6
4

1: Ngày sản xuất 4: Mã QR 2D bao gồm: mã GTIN, số

2: Tên sản phẩm và chức sê-ri, mã kiểu máy, xuất xứ
năng 5: Dữ liệu nhà sản xuất
3: Điện áp cung cấp 6: Các chỉ số về sự tuân thủ và hạn chế
 Hệ thống hóa chất của Aquila
Chỉ có thể sử dụng Máy phân tích Diatron Aquila với Gói thuốc thử Diatro 3P (DRP07). Đây là chất lỏng
nhỏ gọn, tất cả trong một thuốc thử được đặt trong chai HDPE 3000 ml.

Gói thuốc thử có đầu nối được thiết kế đặc biệt với các kênh để cho phép hóa chất và chất
thải di chuyển.

Trên hình minh họa bên dưới là đầu nối thuốc thử tích hợp của máy phân tích . Đầu được đánh số
thứ tự (1-5) được kết nối với nắp silicone của gói thuốc thử để đóng hoàn toàn mạch chất lỏng:
 1

6 3
4
7
5

1: Vào Lyse diff 5: Không sử dụng

2: Khí 6: Đầu nối điện tử với chip khóa hóa chất
3: Vào Diluent 7: Kết nối linh hoạt với máy phân tích
4: Nước thải

Đầu nối hóa chất trong máy phân tích Aquila

Cách kết nối bình hóa chất

KHỞI ĐỘNG MÁY

B1: Kiểm tra nguồn điện và hóa chất sử dụng sau đó nhấn công tắc khởi động phía sau máy

B2: Chạm vào nút “stand by” phía trước máy giữ khoảng 2 giây

B3: Máy tự động vào màn hình đăng nhập

User : Admin
Pass : để trống
 Màn hình đo mặc định

Tại thời điểm này, giao diện người dùng của máy phân tích ‘Aquila’ đã được chuẩn bị để:
 Khởi tạo một phép đo blank mới
 Khởi tạo phép đo bệnh nhân mới (người dùng sẽ nhận được cảnh báo để thực hiện phép đo blank
lần đầu tiên)
 Sử dụng cơ sở dữ liệu bệnh nhân để thêm hoặc sửa đổi các mục nhập
 Xem xét, lưu trữ, gửi đến LIS và in các hồ sơ đo lường hiện có.
 Thay đổi cài đặt máy phân tích.
 Xem lại lịch sử và kết quả hiệu chuẩn và QC.
Tính khả dụng của một số chức năng có thể bị hạn chế (tính năng không được hiển thị hoặc phím chức
năng bị tắt chuyển sang màu xám), tùy thuộc vào cấp độ truy cập của người dùng đã đăng nhập.

TẮT MÁY
Sau khi bạn đã hoàn thành kiểm tra / đo lường và bạn đã sẵn sàng thoát khỏi trình phân tích ‘Aquila’,
hãy nhấn hoặc nhấp vào biểu tượng ‘Tắt máy’ ở góc dưới bên phải của giao diện người dùng.
Một bảng ba tùy chọn xuất hiện (Tùy chọn Tắt máy ).
Giao diện người dùng
Giao diện người dùng đồ họa (GUI) được thiết kế để dễ dàng xử lý. Màn hình chính của ‘Aquila’ được
chia thành các phần chính sau để hiển thị thông tin:

(1) Phần Quick Tabs, để truy cập các nhóm chức năng chính (Đo lường, Kết quả, Bệnh nhân, v.v.)
của máy phân tích
(2) Khu vực hiển thị tương tác và kết quả (phần giữa), với các nút thao tác kích thước lớn. Nội dung
phụ thuộc vào tình huống.
(3) Thanh trạng thái (phần dưới cùng). Vùng này luôn hiển thị
(4) Đăng nhập nhanh . Vùng này phục vụ cho việc thay đổi tài khoản, luôn hiển thị.
Màn hình chính trong khu vực hiển thị tương tác sau khi máy phân tích ‘Aquila’ đã khởi động là:

1 4

1: Quick Tabs 2: Vùng tương tác 3: Thanh trạng thái 4: Trung tâm thông báo
và Tài khoản người dùng
 Cài đặt thời gian hệ thống
Để mở bảng điều chỉnh thời gian hệ thống, trước tiên hãy nhấp hoặc chạm vào thanh trạng thái để
khu vực hiển thị thời gian hiện tại. (được đánh dấu là (1) trên hình bên dưới).

Một bảng cài đặt mới sẽ mở ra(2)Thực hiện cài đặt thời gian

Các tùy chọn có thể đ iều
chỉnh là:
Múi giờ: chọn khu vực hiện tại từ danh sách thả xuống
đ ịnh dạng ngày:Year/Month/Day; Month/Day/Year; Year/Month/Day
Nhập ngày: cho ngày hiện tại,
Giờ, phút: danh sách thả xuống chứa các số chọn thời gian thực tế.

Khi kết thúc quá trình, nhấn nút ‘Save’ lưu cài mới hoặc bỏ qua
Thời gian hệ thống được kiểm soát và lưu giữ trong thanh ghi PC tích hợp.Đồng hồ thời gian thực (RTC)
được trang bị pin Lithium (Li) tuổi thọ cao. Các vấn đề về nguồn điện bên ngoài hoặc vị trí thay thế pin
không ảnh hưởng đến quá trình chạy RTC. Việc thay thế định kỳ pin Li này là một nhiệm vụ bảo trì
Điều khiển cửa máy phân tích
Người vận hành có thể mở hoặc đóng cửa mẫu của máy phân tích, sử dụng (bằng cách nhấp hoặc chạm
vào) 'Trạng thái cửa' trên thanh Status bar

Vùng kiểm soát cửa lấy mẫu

Trong khi mẫu đang chờ phân tích hoặc lấy mẫu xong, nó sẽ hiển thị trạng thái ‘Opened’
Nhấ p đúp hoặc chạm vào vùng màu xanh lam để đóng cửa. Sau khi cánh cửa đóng lại, trạng thái của nó
được hiển thị là Trong quá trình xử lý mẫu, trạng thái ‘Locked’ được hiển thị.

Mặc dù cửa mẫu có một số tính linh hoạt, tránh đặt bất kỳ vật thể nào trong đường chuyển động
của nó. Luôn giữ bàn tay của bạn hoặc các đồ tạo tác khác tránh xa khe cửa mẫu khi bắt đầu đo
hoặc cố ý đóng nó lại.

Đường di chuyển cửa

Khe hở này đóng lại

khi cửa đóng

6.5 Chạy mẫu với Aquila

Trước khi thực hiện bất kỳ phép đo máu toàn phần nào, ‘Aquila’ phải là:
 Khởi động và giao diện người dùng bắt đầu
 Phép đo mẫu trắng phải được thực hiện và được chấ p nhận. Phép đo mẫu người bị vô hiệu hóa
cho đến khi điều kiện này được đáp ứng.

Để tránh rò rỉ thuốc thử và cản trở hệ thống chất lỏng, tuyệt đối không được mở cửa khoang
chứa thuốc thử, tháo đầu nối thuốc thử trong khi quá trình đo đang diễn ra.
 4

1: Bắt đầu phép đo blank 3: Tìm kiếm cơ sở dữ liệu theo ID mẫu

2: Bắt đầu phép đo mẫu 4: Ngày hiện tại

Bắt đầu một phép đo blank

Nhấn (hoặc nhấp vào) ‘BLANK ’ (1) để bắt đầu phép đo trắng. Quá trình ngay lập tức bắt đầu.
Về bản chất, phép đo ‘Blank’ không cần nhập các thuộc tính (ví dụ: ID, loại, ống), tuy nhiên, mỗi phép
đo trắng được chấ p nhận sẽ được lưu trữ trong cơ sở dữ liệu kết quả. Việc xác định bản ghi đo trắng là tự
động. ID mẫu trống được tạo thành BLANK_xxxx.

LƯU Ý: ‘New Measurement’không hoạt động và có màu xám cho đến khi chấ p nhận trị số blank

.
 5
4
1
3
6 2
5 1
2 2
17
26 2
25
2
8 5
1
7
2
5
2
2
9 4
1
7 2
2
5
2 1: Chấ p nhận giá trị Blank 6:Nhận dạng mẫu
2
2: Bắt đầu phép đo Blank mới 7: Khu vực kết quả
1
4: Chức năng bổ sung 8:Khu vực biểu đồ
2
5: In kết quả 9: Khu vưc lỗi
2 Màn hình kết quả Blank

 Chấp nhận kết quả blank bằng cách nhấn nút "Done"

 Lặp lại phép đo trống nếu kết quả không được chấp nhận,bằng cách nhấn vào nút ‘NEW
BLANK ’ (2)
 Việc đánh giá kết quả trắng được hỗ trợ bởi một chỉ báo hiển thị , hiển thị màu xanh lá
nếu kết quả được chấp nhận và cảnh báo màu đỏ nếu kết quả
quá cao. Nếu có lỗi xảy ra trong quá trình đo, nó sẽ được hiển thị dưới dạng

 Mở chức năng quản lý dữ liệu bổ sung bằng cách nhấn nút ‘More’(4),
 Chạy mẫu người mới trên Aquila
Nếu một phép đo mẫu trắng có thể chấp nhận được tồn tại trong máy phân tích sau khi khởi động, hệ
thống cho phép bắt đầu phép đo mẫu người.

Nhấn (hoặc nhấp đúp vào) nút ‘Measure’

bắt đầu một phép đo mẫu. Nút không hoạt động cho đến khi phép đo blank được chấp nhận.

4
1
3
2

1
3
3 2
1 2
3 3
2 2
6

5
6
3
1 1: Bắ t đầu phép đo 4: ID tự động
3 2: Mở bảng dữ liệu bệnh nhân 5: Hướng dẫn cho người dùng
2 3: Thông tin mẫu 6: Mở danh sách

Sau khi hoàn thành việc nhập thông tin mẫu, Tiến hành bỏ mẫu vào vị trí để
mẫu trên máy, hãy bắt đầu quá trình đo máu bằng
cách nhấn "Nút đo’. (Được đánh dấu là (1) trên màn hình nhập mẫu) Trong
quá trình đo, màn hình tạm thời được hiển thị(xem bên dưới) trong quá trình đo có
đếm ngược số giây của thời gian còn lại trước khi kết quả được hiển thị.
1: Quá trình

2
2: ID mẫu

1
 Màn hình kết quả
Sau khi hoàn thành phân tích mẫu, máy phân tích tự đ ộng đẩy mẫu ra bằng cách mở cửa lấy mẫu để
cho phép lấy ống máu ra. Màn hình kết quả nhìn thấy dưới đây được hiển thị khi kết thúc quá trình:

6
9
2 1
1
2 2
5
2
2
1 3
2
28 4
7
5
72 10
51
22
1: Chấp nhận kết quả 6: Hiển thị thông số
12
2: Bắt đầu một mẫu mới 7: Khu vực lỗi
2
3: Lặp lại cùng một mẫu 8: Khu vực biểu đồ
2
4: In kết quả 9: ID mẫu
5: Hiển thị thông tin mẫu 10: Công cụ quản lý dữ liệu

Người dùng có thể thực hiện các thao tác sau trên màn hình này:

 Accept the result with ‘Review’ button, marked as (1). As a consequence, the software
switches to the Review screen (Figure 62), listing the current result to the first list position. When
the operator accepts a measurement result, it will be stored to the measurement database.
 By pressing the ‘Next measure’ button, the operator can continue further human blood
measurement tasks /the button is marked as (2)/. The current measurement is saved to database
automatically, then sample input screen (Figure 41) opens again.
 Repeat the measurement on same sample, if the result is not satisfactory or flagged, by pressing

the ‘Re run’ button. /marked above as (3)/

 The operator can print full report using the ’Print’ button /marked as (4)/

P a g e 73
  Zoom into the histogram for closer inspection, using magnifier icon located in the corner of
histogram. The magnified histogram can be printed individually.
Pay attention to the flag indicator area (7), if a warning flag is displayed. If a result is flagged, repeat it. If
problem persists, follow the troubleshooting instructions. For information about flags, see chapter 6.7
Result interpretation

6.6.1 The Parameter display area

The most important information area of the result display is the parameter screen. On completion of
analysis initially the 8 counted parameters are displayed. These are: WBC, RBC, HGB, MCV, PLT, LYM, MID,
GRA.
NOTE: The blank measurement result display contains only the WBC, RBC, HGB, PLT parameters.

1 2 3 4
1 1 1
1: Parameter name 3: Parameter value
2: Parameter flag region 4: Parameter unit
Figure 48 The result screen parameter display (partial view)

Depending on the measured value, optional flags could appear aside the parameter. The parameter flag
display logic is:
IF PARAMETER VALUE: FLAG INDICATOR: RESULT COLOR:
In range No flag Standard
Over the high limit H, Standard
Exceeds double high limit HH, Standard

Below low limit L, Standard

Below half of low limit LL, Standard

OVER LINEARITY RANGE *, Standard
Symbol displayed with grey, the
OVER DISPLAYABLE range **, ‘--’ is displayed instead of parameter
value

Table 8 Linearity range indicators

P a g e 74
Each parameter has an adjustable limit range, which is related to currently set measurement Profile.
Modification of these limits is discussed in chapter 13.1.

6.6.2 The Histograms

The numerical results are completed with three histograms measured by cell volumetric algorithm. These
are displayed under the parameter result area.

1 2 3 4
1 1 1
1: WBC histogram 3: PLT histogram
2: RBC histogram 4: Magnifier button(s)
Figure 49 Histograms area

Use any of the magnifier buttons (4), to zoom a histogram onto screen. An example of RBC histogram
is shown below:

Figure 50 RBC Histogram magnified view

The horizontal axis of all histograms are scaled in femtoliters. A red color separator line represents the
calculated minimum between the population curves, displaying also the calculated cell volume. (in this
example it is 36 fl). This separator is always calculated and it is a moving limit for each measurement.
On the RBC (and PLT) histogram the 12 fl separator line – also red - splits the platelets’ region into large
and small platelet area. This separator is always fixed at 12 fl.
An example of PLT histogram is shown below, where the previously introduced separators can be observed
in better detail:

P a g e 75
 Figure 51 PLT histogram magnified view

The importance of splitting PLT region into parts is to calculate the P-LCC and P-LCR parameters. See
chapter 3.1.1, where measured parameters and their calculation principles are discussed.
A WBC histogram does not contain fixed separator. An example of WBC histogram is shown here:

Figure 52 WBC histogram in magnified view

The populations of the separated LYM, MID and GRA cells are shown between the separator lines. The
separators are also moving types and their position is calculated by population cardinality.

By tapping or clicking on histogram, the system returns to the result screen (Figure 47. Results )

6.6.3 Managing measurement result

The result of a completed measurement can immediately be handled in a number of ways. These functions
can be accessed by pressing the ‘More’ button (see Figure 47. Results )
These data export features are available at several stages of the user interface such as on the
 blank result screen
 measurement result screen
 review screen

P a g e 76
 Export: creates an .rp report file,- containing the graphical histograms and
parameters - on a selected destination folder. The reportfile requires a
utility software to view on external computer. Please note that no more
than 10.000 items can be exported at the same time.
Send to LIS: the actual measurement record is transferred as a HL7 2.5
standard format message to the LIS server through Ethernet network.
Save RAW data: creates binary report files,- containing graphical
histograms and parameters - on a selected destination storage. Diagnostic
purposes only.
Save to TAB: saving the result in a text file (with .txt extension) on a
selected destination without the graphics.

All the above function is discussed in chapter 7.4 of this manual in details.
The ‘Aquila’ analyzer will be ready to process the next sample after it has finished cleaning and preparing
system hydraulics for the next sample.

6.6.4 Printing the measurement Report

Click or tap the ’Print’ button, on any screen where this button appears, it sends the whole report
to the system printer. An automatic print option also can be set on Printer Settings screen, when the
measurement report is automatically sent to the default printer whenever a measurement result is
accepted.
For further details about adjusting a system printer and other available printing options see more in
section 8.1.5, Setting system printer

P a g e 77
6.7 Interpretation of Results
This chapter provides detailed description about the possible flags which are displayed in ‘Flag region’ of
the screen and gives details for understanding reports provided by the ‘Aquila’ analyzer.

6.7.1 The parameter flags

When user opens a measurement record the parameter names are listed with their standard abbreviation.
Parameter values are always displayed according to their selected unit. If an error is detected during a
sample evaluation, the software will display ‘E’ or” ---" signs to indicate the problem. Those parameter
values falling within the normal range are un-flagged and displayed with black text. Parameter values
falling above the normal range are marked with a ‘H’ and displayed with red text and values falling
below the normal range are marked with a ‘L‘ , and displayed in blue text. (see further explanation
under 6.6.1)

Figure 53. Graphical Normal Range Display

Alerts in the normal range flags occur when a particular parameter is above or below the normal range,
which have been defined for the current patient profile. The flags displayed in the parameter information
area are as follows:
FLAG MEANING DISPLAYED COLOR
CODE
L Parameter is below normal range Value Black
LL Parameter is less then half of the low limit of normal range Value Black
H Parameter is above the normal range Value Black
HH Parameter is greater than twice the high limit of normal Value Black
range
* Parameter value is out of the parameter linearity range Value Black
** Parameter value is out of display range -- Black
Parameter is affected by the too high accepted blank Value Black
!
measurement.
Table 9. Range Flags

P a g e 78
Linearity range flags are raised when a particular parameter is above or below the linearity range of the
device.
The below screenshot illustrates a situation when linearity flags are displayed:

Figure 54 Linearity flag appearance illustration

6.7.2 Blank measurement parameter flags

By the nature of the blank measurement, only values over the threshold are of importance. If any of the
WBC, RBC, PLT or HGB parameters exceed the allowed blank threshold the effected parameter is
displayed with same logic as a high parameter. (H flag.) To make the operators’ task easier, at the same
time a red evaluation warning is displayed. (see an example at Figure 39 Blank result screen).

The acceptable blank measurement automatically evaluated with indicator.

6.7.3 Warning flags

In addition to the previously described parameter flags the Aquila displays warning flags and interpretive
messages in the ‘Warnings’ panel. This is the bottom region of the result screen.
The warning flag is displayed in the particular area of the result screen - marked (1) below - and relates to
the evaluation of the sample.

1 2

1: Warning flags display region 2: Interpretive flags display region

Figure 55. Flag regions of Results Screen

NOTE: it is strongly recommended to repeat a flagged measurement.

P a g e 79
The following tables describe these flags and messages in detail. It also provides guidance on actions the
operator can take to correct the problem described by the flag.
Flags written with uppercase letter are related to WBC issue, lowercase flags are related to RBC/PLT
measurement.

FLAG MEANING DISPLAYED COLOR EXPLANATION, RECOMMENDED USER ACTION

H HGB blank is Patient/Cal/ Repeat blank measurement. If HGB blank is still not
high, or no QC stable, there are probably bubbles in the WBC chamber.
HGB blank Yellow
Run prime lyse, run cleaning and try blank again. Close the
side door if open during measurement.
C WBC Blank/Patien Possible Aperture clogging. Perform an ‘aperture
Clogging t/Cal/QC cleaning’ (15.1.3), Hard Cleaning (15.1.2) and rerun
sample. If ‘C’ warning persists, please, contact your
Red
Service Personnel. Low temperature reagent can cause it
as well (mainly diluent), in this case, you will have to wait
until they reach room temperature.

B WBC blank is Patient/Cal/ Run cleaning or Hard cleaning and repeat blank
high QC measurement.
Yellow
Diluent or system cleanliness problem. Check for bubbles
at reagent inlets, and prime diluent. If problem persist,
call service
REAGENT AND SAMPLING RELATED FLAGS
Rb Reagent Patient/Cal/ Bubbles detected in the reagent pack. Check Reagent
bubble QC Yellow Pack and its connection. Replace Reagent Pack. Repeat
detected the measurement.
Rd Reagent Patient/Cal/ Check Reagent Pack connection. Reconnect the Reagent
disconnecte QC Red pack. Repeat the measurement.
d
Re Reagent Patient/Cal/ Replace Reagent Pack.
Red
expired QC
W1 Sampling Patient/Cal/ No sample in the Shear valve funnel. Repeat sample,
Red
error. QC check sample level
W2 Sampling Patient/Cal/ Blood sensor error, short sample. Repeat sample, check
Red
error. QC sample level in vial
WBC DIFF Pre and post PROCESSING WARNINGS
X Clusterizatio Patient WBC separation error. Repeat sample, check sample
Red
n error condition
R Clusterizatio Patient Clusterization warning, the (MID, LYM, GRA) separation
Yellow
n warning not proper
K WBC Patient Check sample, repeat measurement
concentratio Yellow
n low
J Ghost Patient The ghost domain cannot be separated from the LYM
separation Yellow cluster
error
LM Lymphocyte Patient Warning of an overlap of the domains of the LYM cluster
midscale Yellow and the MID cluster
warning

P a g e 80
LY High WBC Patient Possible lymphocytosis High WBC, MID sample (System
LYM changes the calculation method such, that MID value is
Yellow
population decreased, WBC value is increased)
warning
MG MID, GRA Patient Warning of an overlap of the domains of the GRA cluster
scale Yellow and the MID cluster
warning
Table 10. WBC related warning Flags

Lowercase letters refer to RBC/PLT flags:

FLAG MEANING DISPLAYED COLOR RECOMMENDED USER ACTION

p PLT blank is Patient/Cal/ Run cleaning or Hard cleaning and repeat blank
high, or QC measurement.

no PLT blank Yellow Diluent or system cleanliness problem. Check for bubbles
at reagent inlets, and prime diluent. If it is stable high,
replace the diluent by opening a new tank.

b RBC blank is high Patient/Cal/ Same action as in case of warning flag p. If problem
Yellow
or no RBC blank QC persist call service
c RBC/PLT Blank/Patien Run a ‘Clean’ command (see 15.1.1) whenever the ‘c ’
clogging t/Cal/QC Red flag is dropped, also perform an ‘aperture cleaning’
(15.1.3), Hard Cleaning (15.1.2) and then repeat sample.

m The RBC Patient Treat the RBC result as 'reduced reliability'. Check the
coincidence is sample homogeneity, repeat the sample with manual
close to the Yellow pre-dilution.
limit: RBC count
is too high.
M The RBC Patient Check the sample homogeneity; repeat the sample with
coincidence is manual pre-dilution
over the limit: Yellow
RBC count is too
high.
The PLT-RBC gap Patient Check the sample preparation, its temperature and
l is not clearly homogeneity. Repeat the sample. If the problem persists
detectable on Yellow then perform a manual count on a stained smear.
the PLT-RBC
histogram
RBC Patient Check the homogeneity, the temperature and the
s measurement coagulation of the sample. Repeat the sample.
statistics
warning. The
Red
distribution of
the RBC
detection
changes in time.
Table 11 RBC related warning flags

The interpretative flags are determined by the following rules:

P a g e 81
 INTERPRETATIVE FLAG DISPLAYED INTERPRETATIVE FLAGS INFER THE PRESENCE OF
DISTRIBUTIONAL ABNORMALITIES
Leukopenia WBC LL
Leukocytosis WBC H or WBC HH
Lymphopenia LYM LL
Lymphocytosis LYM HH
Monocytosis MON HH
Anemia RBC L or RBC LL
Polycythemia RBC H or RBC HH
Microcytic Rbc MCV L or MCV LL
Macrocytic Rbc MCV H or MCV HH
Hypochromic MCHC L or MCHC LL
Hyperchromic MCHC H or MCHC HH
Anisocytosis RDWcv H or RDWcv HH
Thrombocytosis PLT H or PLT HH
Thrombocytopenia PLT LL
Microcytic Plt MPV L or MPV LL
Macrocytic Plt MPV H or MPV HH
Table 12. Interpretative Flags displayed by the Aquila

The above detailed interpretations are written to Flag result region as it is illustrated on Figure 55

6.8 About the Sample Identification

Use caution and ensure accurate data entry when manually entering sample ID or patient ID
information into the user interface of the ‘Aquila’ analyzer to avoid possible misidentification of
sample results.
The following sample information are stored to uniquely identify a sample in database:
Sample Profile. (HUMAN, CONTROL, BLANK … ). It is automatically selected by the software depending
on what action the operator initiates
Measurement time: assigned automatically by the ‘Aquila’ analyzer high level software
Sample ID: assigned by the operator
The ‘Aquila’ doesn’t require the sample ID to be unique. Identifier maximum length on user interface is
50 character
The sample ID can submitted by:
o Manual typing
o Bar code reading
o Auto-increment (see more about this feature in chapter 6.8.1)
The sample ID is not applicable on blank measurements
Patient assignment:
A record from the patient database can be assigned to a measurement (see more in 6.5.4)
Patient relation not applicable for blank and QC measurements

P a g e 82
Sequence number. Not displayed directly on user interface. This is an incremental internal row number
between 1 and 99999. This sequence number is automatically assigned by Aquila high level software to
each measurement in database. It can be used for filtering and direct record selection. (See later at
7.2.2)

6.8.1 Using ‘Auto Increment’ identification

On the sample data input screen an option switch is located and it is active in BLANK, QC,
CALIBRATION and HUMAN modes (see Figure 41 New human sample input screen) It is called ‘Auto
Increment’ switch. When it is ‘on’ position, the software generates a unique sequence as sample ID
without the operator’s intervention.
The automatic sample IDs created will be formed following the naming convention below: :
Measurement mode Sample ID created
QC QC_<xxxx>
BLANK Blank_<xxxx>
HUMAN Sample_<xxxx>
Table 13 Automatically generated Sample ID masks

Where <xxxx> represent a 4 digit incremental row number. This identifier is always unique by itself.

6.8.2 Supported Bar Code Symbologies

The table below is applicable if Motorola DS4308 is used with analyzer.
Bar Code Symbology Checksum Status
Code 128 Uses check digits
Code 39 No check digits used. If check digit are present they are considered
part of the sample ID
Interleave 2 of 5 No check digits used. If check digit are present they are considered
part of the sample ID
Codabar Uses check digits
Code 93 Uses check digits
Code 11 Uses check digits
Table 14. Supported Bar Code Reader Symbologies

The manufacturer suggests the usage of such bar code symbologies which contain check digits. This helps
to avoid incorrect bar code readings and recognizes damaged or invalid code.
The supported external barcode reader for Aquila analyzer is Motorola DS 4308S.

P a g e 83
7 Handling the Results
7.1 Overview
The ‘Aquila’ database stores all measured data including sample results, QC, and patient data. Each stored
measurement record includes the complete parameter list, histograms, flags, and sample identification
data. Technical type of measurements (Blank, Stress, Control) are listed together with human samples to,
visually indicating their origin.
The database has no physical limit, it is limited by practical reasons to store up to 10.000 records. Backup
and listing filter options are also available to retain measurement lists.
The Aquila provides a dedicated screen and group of functions to handle the stored records, this is the

second Tab on the main screen, named as ‘Review’. Click or tap the ‘Review ’ tab to open
measurement database.

7.2 The Result Review screen

The database content is displayed in list format, providing search function to particular results. To make a
choice between the list items, the list can be scrolled by using navigation scrollbars (5) or swiping vertically
on the list (this region is gesture sensitive). Selected records can be printed, sent to an LIS system and can
be exported into file. Various sort options –filtered views - are provided to quickly find results.
The main parts of the database review screen are:

3
4
6

1: Open record(s) action button 2: Filter function

3: List of measurements 4: Quick intro tabs
5: Scrollbars 6: Selection indicator
7: Select mode switch

Figure 56. The database review screen

The default display order of the records (3) is the last to first based on their measurement date/time. The
symbols (6) at the beginning of a listed item are representing measurement type, as follows:

P a g e 84
 Human sample measurement
Calibration measurement
Stress measurement
Blank measurement

To open a single or multiple measurements, operator can use the ‘Open’ button (4). The button
remains inactive (grey ) until one record is selected. As a result, the detailed measurement view opens.
(See the detailed discussion in chapter 7.3)
The scrollbar (5) provides a rolling up/down list. The list region of the screen is gesture sensitive. User can
roll the list by swiping up/down.
Before opening the detailed report, the user can make a quick review of the actual selected record
histograms and flag information by using the quick intro tabs area (4). Just click or tap on the tab names
‘Info’, ‘Graph ’or ‘Flags’.
As a default, always the ‘INFO’ tab content is displayed on the Review screen.

This is an example of a ‘GRAPH’ introspective view:

Figure 57 Graph intro view

7.2.1 How to select and open a result

Before a record is opened for a detailed view, the item of interest must be selected. To select a single
record simply click or tap anywhere on the row – selection will be indicated by background color change.
After the selection has happened, click or tap on the ‘Open’ button and the record immediately opens.
A single record selection is reversible by repeating the click and the list item becomes deselected again.
Once a record is opened, the further available features are explained in chapter 7.3
To select multiple records: use the selection indicator icon again as with a single record. Note that making

multi selection is only possible if the ‘Multiselect’ switch (6) is activated. (left upper corner of the
list). Click/Tap once on it and it changes to . This allows any record to be selected individually by
clicking/tapping anywhere in their row. As a result, the selected item background changes blue.

To select a whole set of displayed records, click/tap once again onto the (already) active ‘Multiselect’
switch. As a result, all list items become the ‘Selected’ state and while the ‘Multiselect’ switch changes to

P a g e 85
 . By clicking on it once again (third time), the full selection is cleared and the default state is
restored.

To open multiple measurements, use the ‘Open’ button (4). As a result, the detailed measurement
screen opens. (See details about detailed review at 7.3)
Without opening detailed result view, user can:

Click or tap the ’Print’ button, to send the selected items as report to the system printer.

Click or tap the ’Export’ button, to send all the selected items as an .rp report file to an external
storage.

Click or tap the ’Delete’ button, to delete selected records from the database. For more information
about deleting records please refer to chapter 7.2.3 of this manual.
The Operator still can make the following advanced data operations using
‘More’ (5) button on this review screen:
 Sending one or more selected item to default LIS connection (if active)
 Saving the selection as Tab separated file to external storage device
 Saving the selection as native database export with ‘Save RAW data’
Detailed explanation of these features can be found under the chapter 7.4

7.2.2 How to Filter Displayed Measurements

The primary goal of the ‘Filter’ function is to limit displayed measurement records for practical reasons.
(For example, the operator would like to see only current year/month measurements). The user can
perform a detailed parameter definition and can limit the displayed number of list items using ‘Filter’
button (see Figure 56. The database review screen). The filtered display of records does not
affect the database content and the measurements remain in the database untouched.

As a result of pressing the ‘Filter’ button, the following data input panel is displayed:

P a g e 86
 1

1: Apply filter button 3: Reset filtering to default

2: Save conditions as default 4: Cancel

Figure 58 Database filter window

To sort them, the user can select one or a combination of the following attributes from the database:
 First, activate at least one condition by clicking the checkbox (4) aside the parameter name (on
the example picture above, the ‘TIME INTERVAL’ and ‘HUMAN’ sample profile are the conditions)
 Complete one or more the below conditions accordingly:

FILTER CONDITION DESCRIPTION

SAMPLE ID Sample id is a non-unique, freeform character chain
Partial character set can be used as filter condition
PATIENT ID Patient id is a non-unique, freeform character chain
Partial character set can be used as filter condition
DATE interval Use a from… to… date interval definition completing the two data input fields.
The best resolution is one day. As a result, only those measurements will be
displayed which are made between the defined dates.
PROFILE Can be selected from the dropdown list: HUMAN, MALE, FEMALE, CHILD,
TODDLER, BABY, BLANK. As a result, the selected measure type will be displayed
only
VALIDATION This option switch enables or disables displaying measurements by their
validation state. When
 Filter ‘ON’ AND “Validated” checkbox unselected: only the validated results
are displayed
 Filter ‘OFF’ AND “Validated” checkbox is selected: only not validated results
are displayed

P a g e 87
 FILTER CONDITION DESCRIPTION
INTERVAL A number of days can be set from which the software filters out records. For
example, if this value is set to 10, only records from a 10 day interval will be
displayed before that point.
OUT OF RANGE Only out of range results will be displayed.
Table 15 Filtering attributes

When adjustments on filter panel have been completed, accept setting by clicking or tapping the ‘Apply

Filter’ button (1). The software returns to database list screen (the data Review screen). The
displayed list is now affected by the current filter setting.
If the user has a preference for certain filtering or uses a specific filtering combination frequently, a
filtering configuration can be saved as a default value the user can return to at any point. To do this, the
desired configuration has to be set as previously described, then they have to be retained by pressing the
‘Save As Default’ (2) button.

The user can return to the previously saved default configuration by pressing the ‘Reset to Default’ (3)
button. Making changes to the filter configuration at any point in time does not affect the default
configuration that is saved previously.

Unwanted modifications can be cleared by pressing ‘Cancel’ button (4). Then the previous filter
settings remain unchanged.
The resultant list of items will be affected continuously by the currently set conditions until the filter is
cleared with ‘Filters X’ button.
For more precise filtering, the user may select which parameters are displayed in the review table. To
access this feature, scroll all the way to the right in the review table, then press the button indicated in
the figure below.

Figure 59 Database filter window

The filtering of parameters is done in a similar way as the review table configuration:

P a g e 88
 1 2

Figure 60 Database filter window

1: Parameter filters 4: Reset filtering to default

2: Apply conditions 5: Cancel
3: Save as default

A typical workflow would be as follows:

1. Configure which parameters to display or exclude from the review table by checking or unchecking
the corresponding box (1).
2. If the configuration would be used frequently, it may be saved as default to revert to at any point
in time by pressing the ‘Save as Default’ (3) button. If the desired default values do need to be
reset, use the ‘Reset to Default’ (4) button.
3. To finish the filtering process, press ‘Apply Parameters’ (2). The review table now should only
display parameters configured in this menu.

7.2.3 How to delete a measurement

In IVD devices the deletion of measurements is generally not supported/allowed but technically can be
achieved with certain restrictions. On the Aquila analyzer this action is allowed only for users with highest
user access level, by default. (See more about user management and privileges in chapter 12 Multiuser
Mode.
The Aquila user interface provides the possibility to delete a single measurement or group of selected
records.

P a g e 89
 Figure 61 Deleting single record

Step 1. Start operation with standard list view of the database by tapping or clicking on the ‘Review tab.
Step 2. Use the filtering options to display the required set of records as described in 7.2.2 chapter (This
step is optional, but very useful when operator wants to remove a specific set of measurements)
Step 3. Activate multiselect switch. This action forces the user interface to display the group functions
instead of introspective panels.
Step 4. Do single or multiple selection(s) on the displayed - already filtered - list as described in 7.2.1
chapter
Step 5. After selecting the required measurement records, use the ’Delete’ button by Clicking or
tapping on it. At the end of operation the system displays “0 sample selected” and refreshes the list
without the deleted items.
NOTE The erased record is not actually removed from database but marked with a “deleted” flag in the
database. These items will not be displayed anymore. The restoration of deleted items is possible only by
the intervention of the manufacturer.

P a g e 90
7.3 The detailed result view
After using any of the methods described in the previous chapters, the below screen is displayed:
The detailed result screen displays all 22 available hematology parameters and graphic histogram
information about a measurement. Flag information appears as it was discussed in chapter 6.7

11 10 9

8 7

5
1
1 2
5 4
2 2
1
2
22 6
8 3
73 2
57
25
1: Full hematology parameter list 6: Switch to Previous/Next record
12
2: Histogram region 7: Further management function
21 3: Flag display 8: Back to list view
2 4: Sample identification 9: Print report
2 5: Validate result button 10: Export current measure to .rp
11: Range view switch
Figure 62 The detailed result screen

7.3.1 Switching display to range check mode

The Aquila detailed view screen has a special service to support result evaluation. The detailed view can
be displayed as range relative display mode using the ‘Range check’ switch. This
feature – marked as (11) on Figure 62 – provides a colored display mode to each parameter, displaying
the current value and its range with color code. Activate this control then the
following screen is displayed:

P a g e 91
 Figure 63 The Parameter Range displaying mode

The interpretation of displayed results (Figure 64) is the following:

(1) Parameter name with standard abbreviation
(2) Low range limit for the particular parameter
(3) Parameter actual value in the result. If parameter is less
than the defined low limit, it is written blue. If parameter
exceeds the defined high limit, it is written red.
(4) High range limit for the particular parameter. The colored
line lengths are proportional with the diversion.

1 2 3 4
5 2
2 64 Range
Figure 2 display interpretation
1
7.3.2 The parameter display region
2
The region marked (1), on Figure 62 contains a full set of measured parameters, displaying them in the
2
currently set units. The style of parameters displayed is determined by the relation of the parameter with
its permissible ranges. These were previously described in the following chapters of this manual: 6.6.1 The
Parameter display area, 6.7.1 The parameter flags.
Each parameter has its own adjustable limit range, which is also related to currently set measurement
type. Modification of these limits is described in chapter 13.

7.3.3 The histograms region

The region marked (2), on Figure 62 contains the actual measurement histograms. All features and
properties of histograms are identical as it already was described in chapter 6.6.2 The Histograms

P a g e 92
 7.3.4 The flags display region
The region marked (3), on Figure 62 is containing the actual measurement record warning and interpretive
flags. All features and properties of flagging method are identical as described in chapters 6.7.3 Warning
flags.

For a better view of the flags, the detailed view screen has a special button: ‘Details’ , which
opens a magnified summary window about current measurement flag content. This is shown below:

Figure 65 Flag details pop up window

In the case of results flagged ‘INVALID’, the details of the error that triggered the flag will be described in
the ‘Related Errors’ section.
Operator can close this window and can return to detailed view using the ‘Close ’ button.

7.3.5 The sample identification region

The region on the detailed view marked (4) on Figure 62, displays the actual sample identification data:
The displayed sample identifier attributes are:
Sample type: (HUMAN, CONTROL …etc.)
Sample ID: the first ten characters are displayed
Measure date: format is determined by
localization settings
Measure time: displayed format is determined
by localization settings
Patient name: Title+ First + Family name
Patient id: (optional, from local patient table)
Birth date: (optional, from local patient table)
Patient age: (optional, from local patient table)
Figure 66 Sample identification

P a g e 93
For more detailed information about the applicable measurement attributes, refer to chapter 6.5.3, where
sample attributes are explained.

7.3.6 How to validate a measurement

The validation function is planned to support laboratory workflow, such as when the device operator who
executes sample measurements and the person responsible for evaluating the patient results are
different.
When analyzer user accounts are defined (Chapter 12), the ‘Validation’ privilege must assign to user of
the Aquila. The ‘Validate’ feature will appear only for this user level.

On the Review screen, the sample identification area (Figure 66) has a special action button.
By pressing this button the software writes a ‘Validated’ attribute into the database and displays the result
from that moment with ‘Validated’ status. See an example below (Figure 67):
‘Validated’ status proves that the
responsible person has revised the
measurement and it can be
transferred to further process.
To revoke validation is only
possible for those accounts where
this privilege is enabled.

Figure 67 Validated / Not validated status

7.3.7 How to Switch between the displayed results

The full detailed view screen provides two control buttons to switch between the currently displayed
database elements. These controls are only active if previously, more measurement records were selected
on the list view screen. On the Figure 62 these controls are marked with (6). See a partial screenshot
below, Figure 68.
The inactive control is colored to a grey background, the
active control is blue. Click or tap on the buttons to move
through records. When the first item of set is reached, the

‘Previous ’ button becomes inactive, when the last

displayable list item is reached the ‘Next’ control

button becomes inactive.
When the user is working with multiple measurement
records, the actual screen displays a counter on the
top region to inform user which result is actually displayed
from the set.
Figure 68 Previous/Next controls

P a g e 94
 7.3.8 Creating report file
This function saves the full set of measurement results into a special file format for further use or backup
purposes. File is a binary format, its extension is: .rp. Report file contains all measured parameters,
graphical histograms and flags as well.
How to create an .rp export :
Open the measurement record which is the subject of interest onto the detailed view screen.

Click or tap on the ‘Export’ button (located on the top of the result screen, marked as (10)
on Figure 62 ) then the below seen panel appears.
The system displays the file / folder content of the first available removable drive, which is connected to
analyzer. Remark: if available, always a removable drive is shown first as target drive.

Choose another target using the drive browser (1) or go to next step.
On the file listing area (2) the root folder of the target is shown.

1
5
2 3
1 2
2
2
1
2
5
2
1
2
2

1: Found removable drives 2: File list on target 3: Save export

Figure 69 Result export screen

If the target path is acceptable, press the ‘Save’ button (3). The displayed result file is automatically
saved. To browse another target drive, use the region marked as (1) on Figure 69. The file name is
generated on the target folder is the measurement record unique internal sequence identifier:
<SEQ_ID>.rp, where SEQ_ID is between 1 and 99999.
Important: if previously the operator selected multiple number of records, the export command results
such number of exported .rp file on the target drive as many of records was selected. In other words, each
measurement is exported to one report file.
Please refer to chapter 7.2.1 for the details, how to select multiple measurement from data list.

P a g e 95
 7.3.9 Printing the result

The ‘Print’ action button, - marked as (9) on Figure 62 - sends the currently displayed
measurement to system printer in one click/touch.
Important: if user is working with a multiple set of measurement records and going to print them all, then
the user can choose another feature instead of printing them one by one from the detailed view.
Follow the method of group selection as described earlier in chapter 7.2.1. Then, after finishing the
selection, click or tap the ’Print’ button, to send all the items to the system printer. Please note that
no more than 200 results can be printed at the same time. The selected records will be printed one by one
in a single action. (This process is illustrated on ). For more information about the available printing report
format, please refer to the Appendix, 18.5.

7.4 Managing the stored measurement data

The detailed result view screen provides a set of features (they are hidden on a drop down list as default)

to work with database items. Select the button on the user interface, which reveals the
following set of functions (Figure 70):
The data management drop down menu appears with identical
format and functionality as on Blank result screen (Figure 39) and
Human sample result screen (Figure 47) as well.
The details and use of these features are discussed in the next
subchapters.

Figure 70 Data Management functions

The following subchapters describe the above shown data management functions as ‘Import’, ‘Sending
record to LIS’, ‘Save raw data’, ‘Save to TAB’ and ‘Delete’ record.

7.4.1 Export limitations

The simultaneous export of measurement data is limited to the following quantities:
Send to LIS 200
Save to tab 10.000
Save raw data 10.000

P a g e 96
 7.4.2 Sending to LIS
The ‘Send to LIS’ button immediately transmits the current or all (if the user is working in
multiselect mode) the selected database records to the external LIS system. The transfer channel is the
Ethernet network. The LIS server parameter (IP address, port) must be set under analyzer’s LIS settings
menu first.
The message format is standardized and compliant with HL7 2.5 message standards.
Diatron Aquila has an individual document of LIS communication: Diatron_Aquila_HL7_Communication
Protocol r01.pdf. For further information contact Diatron Technical Support at support@diatron.com.

7.4.3 Save Tab File

The ‘Save to tab’ function is used to archive database item(s) to a tabulator separated text
file. The purpose of this feature to allow the usage of data lists in a spreadsheet application. The operator
must select the records first which are going to be saved into text. (See multiselect mode in section 7.2.1)
The function can be started from the detailed review screen also.
The output file contains only blood parameter data, does not include histogram graphics. See a sample in
section 18.6.
Insert a USB data storage device into one of the USB inputs of the ‘Aquila’ analyzer. After pressing ‘Save
to tab’ button, system displays the below browser panel (Figure 71):

1 2
5 1
2 5
1 23
2 12
2 2
2

Figure 71 Save to tab target selector

Select the required target drive (1) by tapping on its letter. Only removable devices are listed. The drive
current content also listed. To continue operation, click or tap ‘Save’ button (2) and the export file is
saved to target root. If necessary, a user can create a new target folder by using ‘New folder’ (3)
action button. The latter case the below input panel opens:

P a g e 97
 2
1
1
5
5
2
2
1
3 1
2
2 2
2
2
Figure 72 Creating output folder

Enter the new folder name to ‘Folder name’ input field (1). The result path is displayed in ‘Folder path’
(3) field. Confirm the creation of a new file folder by pressing the ‘Create folder’ (2) button.
The ‘Save to tab’ function generates a filename automatically in the following format:
Tab_<DD>.<MM>.<YYYY>__<HH>_<MM>_<SS>_<NN>.txt where,
<YYYY> : current year, on 4 digits
<NN>: Aquila serial number 7 digits
<MM> and <DD>: current month and day in 2 digits
<HH>_<MM>_<SS> : the current system time stamp, hours, minutes , seconds in 2 digits separated with
an ‘_’ underline character. (example: Tab_09.09.2017_23_58_44_D0300XX.txt)
Tab separated text files can be loaded and viewed by a text editor or imported into spreadsheet software.
To archive database data using this function, insert a USB data storage device in one of the USB inputs on
the rear panel of the ‘Aquila’ analyzer. Select the file location of your USB data storage device and click or
tap the ‘Save’ button to begin the export.
See section Appendix 18.6 for a sample about the internal format of a tab separated text file.

7.4.4 Save Raw Data

The Save Raw Data function saves native binary data information associated with a selection of database
records. Raw data files are only suitable for internal use by Diatron staff. Your service engineer may ask
you to save raw data files to help diagnose a service issue.
Insert a USB data storage device into any USB inputs on the rear panel of the ‘Aquila’ analyzer. Click or tap
the ‘Save raw data’ button on the ‘More’ drop down panel (Figure 70). System displays the
below seen panel. Select your USB data storage device as a target, then click or tap the ‘Save’ button to
complete export.

P a g e 98
 1 2
5 1
2 5
1 23
2 12
2 2
2

Figure 73 Save raw data panel

The result of the export action is three binary file (hgb.bin, rbc_full.bin, wbc_full.bin) for each
measurement, organized into a folder structure. The collector folder is named SaveData, the
subdirectories are named by the measurement timestamp. Folder mask:
<yyyy>_<mm>_<dd>_<hh>_<mm>_<ss>. Example:

View of exported measurements on the computer

Saving raw data is only possible if a special setting is enabled under ‘System preferences’. To allow this,

select ‘Menu’ tab (Figure 74), open ‘Settings’ group by its icon , then enter ‘System preferences’

group and finally activate the ‘Save RAW Data’ switch on the opening panel. (See reference
under 8.1.3)

7.4.5 Deleting a record

By clicking or tapping on the ‘Delete’ button, it erases the currently displayed measurement.
User must confirm the illustrated warning below before the operation is completed.

P a g e 99
 Figure 68a. Erase of record confirmation warning

NOTE: the deleted items do not removed physically from database but never appear again in result list or
as search result.

P a g e 100
8 Customizing the Analyzer

The ‘Menu’ Tab (Figure 74b) collects a large set of the utility, customization and maintenance
features of the analyzer software. In the present chapter the analyzer general settings will be discussed.
The quality control, calibration functions, patient database handling, device maintenance services and
user management are discussed in their standalone chapters.
The following set of function groups are available from ‘Menu’ screen for a full access right user:

1 2 3 4 5 6

1: QC features 4: General settings

2: Calibration function 5: Collection of diagnostic features
3: Maintenance functions 6: User manage
Figure 74b The content of Menu tab

Use the following quick links to jump to the following specific topics:

 Quality Control (1) is explained in chapter 10 Quality Control

 Calibration process (2) is explained in chapter 9 Calibration
 System maintenance (3) is explained in chapter 15 Maintenance of the Analyzer
 System diagnostic features (5) are explained in chapter 14 Instrument Diagnostics
 User management (6) features are explained in chapter 12 The Multi-User Mode
This menu is available only for high access level users.

P a g e 101
8.1 General settings of the Analyzer

To access this group of settings, open ‘Menu’ tab (Figure 74) then click or tap on ‘Settings’
icon. The opening new screen is the collection of the following functions:

4 7 2 5 6

1: Localization 5: Printer settings

2: Network settings 6: Service functions
3: System preferences 7: Profile limits
4: Units
Figure 75 Analyzer’s general settings screen

The present 8.1 chapter is discussing the (1) to (7) of the above functions. The profile limit setting is
discussed in a standalone chapter. (click here to jump: 13 Setting Parameter Ranges )

8.1.1 Language and regional settings

Click or tap on the ‘Customize’ icon (1) on the ‘General settings’ screen (Figure 75) and the regional
setting panel (see a partial screenshot below) opens to provide the adjustment of the:

1 3

1: Language selector 3: Keyboard layout

2: Printout custom texts
Figure 76 Regional and key map settings

P a g e 102
Language (1) of the user interface. Available options in the dropdown list: ENGLISH; GERMAN;
INDONESIAN; ITALIAN; GREEK
Keyboard layout (3) of the user interface virtual keyboard and the external keyboard. Selectable
options: English (US); English (UK), Spanish, Chinese (Simplified), German, Japanese, Indonesian, Italian
Printout header field 1..4 (5): The four custom filled text field serve for customizing printout appearance
with user defined data such as laboratory header, doctor name etc. For more about the final appearance,
see the printout example at 18.5.

Return to ‘Settings’ main screen by clicking or tapping the button.

8.1.2 Network settings

The following chapter explains advanced network adjustments. To determine certain parameters may
require some help of local network administrator or IT affiliate.

Click or tap on the ‘Network settings’ icon (2) on the ‘General settings’ screen (Figure 75), and the
below setting panel opens:

1 2

1: Local network settings 2: LIS HOST settings

Figure 77 Network settings panel

The screen is divided to two main parts horizontally. The Network settings are always visible on the left
pane, but parameters can be changed only, when ‘Enable DHCP’ is inactive. The LIS settings – on the right

pane - become visible only if when ‘Enable LIS’ switch is active. In the latter case the analyzer’s
built-in computer settings become visible. The local port field is visible only, when bidirectional LIS’
is active.
Right panel (2) “LIS” settings:
Enable LIS ON/OFF: activate or deactivate HL7 message sending function.
Image sending ON/OFF: Enables /Disables sending histogram graphics within the HL7 message.

P a g e 103
Auto Sending ON/OFF: Enables /Disables automatic sending of results toward LIS host server. Note:
Blank result is not transferred automatically to LIS.
Bidirectional LIS ON/OFF: Enables /Disables bidirectional communication. To receive a worklist from LIS,
this setting is obligatory.
Remote IP: The IP address of the LIS host computer.
Remote port: the IP socket port number of the LIS host.
Local port: the IP socket port number of the analyzer
Left panel (1), “Bidirectional” settings
Enable DHCP ON/OFF: Enables/disables obtaining an IP address from DHCP server in the connected
network. This switch is enabled and usable only when analyzer is connected to a living network
environment.
IP address: the analyzer IP address (IPv4)
Subnet mask: The currently connected LAN subnetwork mask
Gateway: the default gateway IP address in the network. N.B. The gateway setting is used only when LIS
host computer is out of current subnetwork, thus analyzer must communicate through a router or firewall.
Confirm all changes by clicking or tapping the ‘Apply’ button which transfers the
parameters to analyzer network driver. The effect is immediate. User can abandon the IP settings changes
by tapping or clicking the ‘Discard’ button.
When DHCP requesting is activated, no manual settings are needed in IP parameters. At the same time, a

special change takes place on this screen. The ‘Renew’ button appears at the bottom.
The aim of this ‘Renew’ feature to send an IP renewal request to local DHCP server.
IMPORTANT NOTE: the network configuration changes take effect only, if analyzer is connected to a LAN.

Return to ‘Settings’ screen by clicking or tapping on the button.

8.1.3 System Preferences

Click or tap on the ‘System preferences’ icon (3) on the ‘Settings screen’ (Figure 75), and the
preferences adjustment panel opens to provide the adjustment of the:

Figure 78 System preferences

Screen Off time: Inactive, 1, 2, 3, 5, 10, 15, 20, 25, 30, 45 minutes, 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs

P a g e 104
This setting regulates after how many minutes the display is switched off. Inactive setting lets display on
for full worktime.
Standby time: Inactive, 1, 3, 5 ,10, 15, 30, 60 minutes
Standby time – This defines the time period of inactivity before the analyzer automatically leaves the ready
state and drains the pneumatic components to prepare for overnight standby. If this time is set to zero,
the analyzer will never enter the standby state automatically.
Blank request: Inactive, 1-12 hours (in 1 hour resolution)
This setting determines how frequently the analyzer needs to have a blank measurement before allowing
new human sample measurement, thus preventing the obstruction of measurement pipes caused by
bubble formation in the fluidic system. Depending on the set time interval, the software displays a warning
to user to execute a blank measurement before performing normal sample analysis. The default setting is
8 hours. The blank request timer restarts at the completion of a blank measurement without error.
Other maintenance processes fluidic processes (e.g. prime, cleaning), stress measurements, a full self-test
or a recovery process invalidate the current valid blank measurement/results and blank request timer will
be initialized, but not restarted.
Each time when the analyzer is started from the power off state, the blank restriction is active. If analyzer
is used in a continuous 7/24 week/hour work mode and never shuts down, then the ‘Blank request’ time
interval determines the obligatory period of blank measurement. Mandatory Blank request is also
activated after 48 hours fluidics inactive period.
Save RAW data: Enable/Disable
This feature does enables/disables to store measurement system related low level information. Enabling
this feature results in the extension of recorded data to each measurement. It serves for diagnostic
purposes only. Enabling this feature will increase the database storage requirement. The location that the
extra data is saved to:
D:\SaveData folder, where D: represents the secondary partition of the analyzer file system.
Volume: adjustable slider to control the loudness of sound effects.
This setting adjusts the built-in speaker volume level. The Aquila analyzer associates certain sound effects
to measurement events and user actions. It can be set to zero level, when Aquila does not emit any sound.

Return to ‘Settings’ screen by clicking or tapping the button.

Extended QC: Enable/Disable
Secondary QC limit can be defined in ‘Extended QC’ screen using EDIT EXTENDED QC VALUES option.
EDIT EXTENDED QC VALUES: You can set the Extended QC parameter ranges in % by the screen that is
opened with it.

P a g e 105
 Figure 79 Extended QC range setting screen

Limitation notes: in ‘Extended QC’ some settings are valid only in the concentration range indicated next
to the parameter. E.g.: WBC ‘Extended QC’ value can be used only in the range of 2 -30 109/L. The WBC
measurements of control materials having WBC target value out of this range will not be validated by the
‘Extended QC’ criteria.
The results in QC database measured before turning on ‘Extended QC’ mode will not be re-evaluated by
the ‘Extended QC’ limits.
A new Control file must be defined if any ‘Extended QC’ parameter limit is changed. The following message
will warn you about it:

Figure 80 New QC reference warning message

8.1.4 Setting the units of te measured parameters

Click or tap on the ‘Units’ icon (4) on the ‘Settings’ screen (Figure 75). The ‘Units’ panel (Figure 81
Unit settings) opens to allow the adjustment of

P a g e 106
 Figure 81 Unit settings

HGB unit: g/dL, g/L, mmol/L

Cell count unit: cells/µL, Cell/L, cells/mm3
PCT/HCT unit: %, Abs
MCV unit: fL, µm3
All selectable options are located on drop down lists. Click the required list and select unit. After changing
units, the measurement results are displayed in the new units. The required value conversions are
automatically executed on displayed parameters. Return to ‘Settings’ screen by clicking or tapping the
button.

8.1.5 Setting up a system Printer

Click or tap on the ‘Printer settings’ icon (5) on the ‘General settings’ screen (Figure 75), and the
‘Printer settings’ panel opens to allow the adjustments of the options seen below:

1
2

2 5
2
4
1
2
23

Figure 82 Printer settings

1: Current printers (dropdown list) 4: Automatic print

2: Printing options 5: Paper size
3: Add new printer options (only for service)

Printer device selection: the (1) drop down list shows all the printers detected by the analyzer’s operating
system. Selecting a device from the list, will be the default printer where the analyzer printouts are sent.

P a g e 107
Color printing: ON/OFF (2) This setting allows to send color printing information to the selected printer
device to create colored printouts.
Automatic print: ON/OFF (4) This setting allows the analyzer to send all measurement reports
automatically to default printer as soon the measurement result is accepted.
Printing Paper size: A4/Letter
NOTE: the following three functions are available only for users with “Service” level privileges.
Add Device (3): This button starts the “Add Printer Driver Wizard” of the core Windows 8.1/10 operating
system. The wizard guides the operator through the process of selecting a new system printer. The choice
is limited to currently available Windows (built-in) compatible printers. As a result, at the end of the
process the new printer will appear in the dropdown list as a valid option.
Run Installer (3): By clicking or tapping this icon, it opens a file browser to allow the run of an external
executable application within the operating system. Use this option when a printer is shipped with its own
installable driver program and it does not exist amongst the built-in drivers.
Add Printer (3): By clicking or tapping this icon, the analyzer GUI starts the “Add Printer” wizard of
Windows Control Panel. With help of this feature, the user can select local or a shared network printer as
well. The available choice is limited to built-in models. Use this option when situation requires to create
printer port manually or an existing shared network printer is the target.

When modifications have been completed, confirm changes by tapping the ‘Save’ button or abandon

changes by pressing the ‘Discard’ button. Return to ‘Settings’ screen by clicking or tapping the
button.

8.1.6 Service settings –updating the software

This feature allows running of installers from an external storage. This screen is dedicated to run the high
level software (HLS) installer or upload newer version of the low level software (LLS).
CAUTION: Improper software installation may cause system running failure.

System Software upgrade can be done without using any special menu:
It is as easy just connect the media containing HLS and /or LLS installer file to any of the USB ports. Pay
attention that the installation resources shall be copied into the root folder of the USB drive. The system
recognizes the upgrade files and ask a confirmation for the process. Select OK for upgrade.

CAUTION: Please do not pull out USB stick during update

Software upgrade status bar is displayed during the upgrade process.

Alternative way of the System Software upgrade is clicking or taping on the ‘Service settings’ icon (6)
on the ‘General settings’ screen (Figure 75), and the below screen opens:

P a g e 108
 2
2
12
5
2
1 Figure 83 Software update for service
2
1: Running installer for HLS 2: Update LLS
2
Step 1. Connect the media containing HLS and /or LLS installer file to any of the USB ports. By

pressing the ‘High Level Update’ or ‘Low Level Update’ buttons, the below seen
screen opens :
If multiple drive sensed as connected, use the drive selector first (1)
Step 2. Select the executable by clicking or tapping on its name (2)
Step 3. Press the ‘Run’ icon and wait until installation is finished. During procedure the
application will restart the analyzer
Step 4. Optionally repeat the process if both HLS and LLS update is necessary.

3
1
5
2
1
22
22
2

Figure 84 Update software panel

1:Available Removable drives 3: Start installer button

2: List of found executables

NOTE: The distribution format of high level software is executable (.msi), the low level components are
distributed in .dat file format.
For further details about service related customization see Service manual.

P a g e 109
Return to ‘Settings’ main screen by clicking or tapping the button.

9 Calibration
The ‘Aquila’ analyzer must be calibrated in order to provide correct, reliable results. The manufacturer
ships Aquila analyzer in calibrated condition. Calibration procedure is suggested at:
 initial installation
 after replacing any component which is critical to the dilution or measurement process
 any time when quality control shows a systematic result deviation or it is outside the predefined
limits
 at periodic time intervals determined by laboratory regulations
The ‘Aquila’ analyzer calibration process is made using calibrator material or with a human whole blood
sample with known parameters. The known parameter values and the average values of multiple runs are
used to calculate calibration factors. The new calibration factors are take effect once they are accepted by
the operator.
If you are using a human whole blood as a calibrator, the calibration target values must be measured on
a reference analyzer according to applicable regulations, standards, or laboratory procedures.
The automated calibration procedure guides the operator through the calibration process and performs
the calculations of factors. Calibration factors can also be modified directly without running a calibration
measurement procedure. Only the parameters which are traceable to reference methods are calibrated:
WBC, RBC, PLT, HGB, MCV, and MPV.
The limits of the calibration target values are linked to the normal range of the ‘Human’ sample mode.

Calibrator material and sample tubes should be handled as a potentially biohazardous material. All
applicable laws, regulations, and laboratory practices should be followed in the handling and disposal
of calibrator materials.

9.1 Calibrating the ‘Aquila’ analyzer

To access the calibration functions of the ‘Aquila’ analyzer, open ‘Menu’ tab (Figure 74) then

click or tap on ‘Calibration menu’ icon. The ‘Calibration’ screen of the user interface offers the
following functions for supporting the calibration process:

 Setting calibration reference values

 Performing the calibration measurement
 Setting calibration factors manually
 Reviewing calibration result
 Reviewing calibration history
9.1.1 The calibration screen

To access this group of calibration functions, open ‘Menu’ tab (Figure 74) then click or tap on

‘Calibration’ icon.

P a g e 110
 2 3 4 5

Figure 85 Calibration screen

1: Start the calibration measurement 4: View calibration results

2: Set factors manually 5: View calibration history
3: Set calibration references 6: Blank

9.2 Setting calibration reference values

At the first calibration event or when a new calibrator LOT is going to be used, the reference values for
the new calibrator must set. Click or tap Calibration reference button (3), then the list panel below
opens:

1 2

Figure 86 Calibrator references list

1: Add a new set 2: Edit a set

Expired calibration items are displayed in gray color in list. User can ‘Edit’ existing reference set by pressing
the button or can add a new set by pressing the ‘New’ button. In both cases the reference editor
below opens:

P a g e 111
 1 2 3 4
3

Figure 87 Calibration reference editor

1: LOT number 4: Parameter input field

2: Calibrator type selector 5: Save button
3: Expiry date 6: Cancel button

How to set the reference values:

Step 1. Enter the LOT number of calibrator material in the input field marked as (1). This information is
obligatory.
Step 2. Select the calibrator type (2) (HUMAN/CONTROL/CALIBRATOR) accordingly, to which kind of blood
is used for calibration. NOTE: The correct selection is important as HUMAN and semi-artificial
CALIBRATOR bloods are measured with different chamber setups.
Step 3. Set the expiration date for the current reference material in the input field (3)
Step 4. Fill the obligatory calibration parameters as WBC, RBC, PLT, MPV, HGB, MCV, RDWcv. Pay attention
to the indicated units on the screen. Use the values from calibration material assay sheet or the
reference values of the measured human sample.
Step 5. When modifications are finished, confirm changes by tapping ‘Save result ’ button or

abandon changes by pressing ‘Discard’ button. N.B: the ‘Save result’ button becomes active only
when all parameters are correctly filled . After these adjustment steps the analyzer is ready for
measurement process (9.3) and will consider the above set values.

9.2.1 Using a barcode reader to set calibration reference values

The Aquila high level software is able to recognize and accept the above reference values from barcode
reader. All genuine Diatron control/calibrator material have a printout, which contains the full assay
content coded into a 2D barcode.
Step 1. Connect the reader to any of the analyzer USB ports.
Step 2. Go to any of the main screens. (Measure, Patient, Review, Menu)
Step 3. Read the code from calibrator sheet or from computer display. If BCR successfully decodes the
2D barcode, system emits a sound.

P a g e 112
Step 4. After a few seconds, the reference values automatically appear within the reference editor
panel.
Step 5. Press ‘Save’ , if displayed information and LOT name is correct. NOTE: a reference set cannot
be saved if a LOT already exists with same name. In this case rename the new LOT manually.

9.3 Performing a Calibration measurement

To perform the automated calibration procedure, ensure that the ‘Aquila’ pneumatic system is active and
that a valid blank measurement has been accepted. Perform the following steps:
Step 1. Prepare a sample tube with calibrator material or human whole blood. Ensure that there is
sufficient sample volume for three consecutive runs.
Step 2. Place the calibrator sample tube in the sample door.

Step 3. Click or tap the ‘Calibration measure’ button (1) on the ‘Calibration ’ main function screen.

1 2 3

4
1

Figure 88 Calibration measure

1: Calibration sample ID 3: Control reference name

3: Start calibration button 4: Number of measurement cycles

Step 4. Give a sample ID (1) if measurement name is required

Step 5. Select the number of calibration measurement cycles (4) that many is planned to run. Possible
numbers are: 3,5,7.
Step 6. Select ‘Reference’ name (2) of current calibrator material. This reference set was defined
during “Setting calibration reference” procedure. Now, make sure the sample is well homogenized
and inserted. Vial should be uncapped.
Step 7. Click or tap the ‘Measure’ button (3) to start procedure. The counter shows how many
steps will be performed. A temporary screen will be displayed while the measurement process is on-
going.

P a g e 113
 Do not remove the calibrator or control sample vial from analyzer when it is returned.
Step 8. At the end of measurement, the first result is displayed:

P a g e 114
 Figure 89 Calibration measurement result screen

Step 9. Click or tap the ‘Next measure’ button if result is acceptable (no warning flag, no
parameter range flag, results fit to assay values) or press ‘Reject and rerun’ to repeat this
measurement. The user can abandon whole calibration process by pressing ‘Exit’ . This process
will be repeated three (five or seven) times by analyzer automatically, but Operator must accept each
measurement.
Step 10. After the last calibration measurement the function of ‘Next measure’ button changes. Click
or tap this ‘Evaluate’ button to go further with the process, as result the evaluation screen is
displayed:

Figure 90 Calibration evaluation screen

The calibration procedure ends when all three (five or seven) calibration runs are completed. The
calibration factors are calculated and presented in the calibrator evaluation screen (Figure 90) The
previous calibration factors and the coefficient of variation (CV) of the sample runs for each parameter

P a g e 115
are also displayed. If the calculated coefficient variation exceeds the allowed limit – due to unreliable
measurement sequence -, then new values are refused and cannot be saved.

Step 11. Select ‘Accept’ to replace the current calibration factors with the accepted factors.

Selecting ‘Reject’ abandons the entire calibration process.

The measurement based calibration process can be replaced with the ‘Manual’ calibration mode if the
deviation is calculated. See next chapter about manual calibration.

9.4 Performing manual calibration

An ‘Admin’ user or other ‘Advanced’ role user can directly modify the calibration factors. This action does
not require control blood material and performing the full calibration measurement process.

9.4.1 Setting factors manually

On the ‘Calibration’ screen (Figure 91) click or tap onto ‘Manual Calibration’ icon, which opens the
following editor panel:

Figure 91 Calibration factor editor

Note: The original factors are not shown here, the displayed values (default is 1.00) multiply the
background parameter factors with the hereby set value.
Example: To increase the WBC count by 2%, enter 1.02 into the WBC factor field.

When modifications are finished, confirm changes by ‘Save’ button, or fully abandon them by

pressing the ‘Discard’ button.

9.5 View Calibrations Result

The view calibrations feature is helpful for reviewing the calibration history of the analyzer. Increasing or
decreasing trends in calibration values over the time may indicate a problem that requires service

P a g e 116
intervention. On the ‘Calibration screen’ (Figure 92) click or tap onto ‘Calibration result’ icon, which
opens the following screen:

Figure 92 Calibration results overview

The user can see an overview any of the results by pressing the ‘Open’ button located in
the result row of interest. As a result, the detailed view of that particular measurement opens.
Further actions can be initiated with the selected calibration result items by pressing the ‘More’
button, such as
 Sending to LIS
 Saving RAW data
 Exporting (to report file)
 Saving To Tab file
 Deleting item
For detailed information about the above features refer to chapter 7.4
Return to ‘Calibration’ function screen from the ‘Calibration results’
overview by clicking or tapping the button.
Any calibration can be deleted, from detailed view screen. Deleting the
last calibration causes the ‘Aquila’ analyzer to revert to the last
accepted calibration factors.

P a g e 117
9.6 View Calibration history
This function serves to list the calibration events that have happened on Aquila analyzer. On the

Calibration screen, click or tap onto ‘Calibration history’ icon, which opens the following screen:

Figure 93 Calibration history (partial list view)

The calibration history list displays all events in chronological order. The displayed attributes are:
ATTRIBUTE DESCRIPTION
CReation date The date when calibration event was performed
CREATed by The user account name who performed calibration
TYPE The user access level, that the measurement created by. Possible values:
SERVICE; USER
SET of Factors Each hematology parameter has its own factor. The parameters which are
displayed WBC, RBC, HGB, PLT, MCV, MPV.
Allowed value of calibration factors are between 0,7 .. 1,3

By clicking or tapping the ‘More’ button, the dropdown list reveals a print function from
where the history can be printed. Note: Calibration History printing option is not available by Zebra
ZQ320 thermoprinter. Please select alternative printer in Menu/Setting/Printer setting window. see:
chapter 8.1.5 Setting up a system Printer

Return to ‘Calibration’ screen by clicking or tapping the button.

P a g e 118
10 Quality Control
Stable recovery of standard QC material parameters assures the operator that the ‘Aquila’ is operating
consistently on a day-to-day basis and is functioning correctly.
Mandatory QC measurement requirement can be set by QC Lock Out setting. This option may be enabled
in Service mode and it blocks the patient measurements without valid QC result(s). See: Chapter 6.2
By analyzing control materials on a regular basis, day-to-day reproducibility and general condition of the
analyzer can be monitored. Target values and acceptable (tolerance) ranges for each parameter can be
specified for an unlimited number of QC materials.

Control materials must be used before their expiration date. Always observe the control
manufacturer’s instructions for storage and use. Control materials must be well mixed before use.
Diatron recommends the use of genuine Diacon3 controls from Diatron. (3.1.2 Approved Control and
Calibration Materials)
The ‘Aquila’ analyzer does not limit the number of QC material lots or the number of QC measurement
runs that are stored in the control database. Each QC measurement run is saved to the selected QC
material lot.
QC lots can be control materials or a whole human blood sample whose parameter values and ranges are
determined by other means.
‘Extended QC’ mode: the QC menu gives opportunity to use secondary QC limits for some selected
parameters, if the ‘Extended QC’ option is enabled in Menu/Setting/System Preferences screen. The
primary QC limits are defined in absolute ranges while the secondary ones are in percentage of target
values. The QC results are displayed with absolute ranges also of the parameters ‘Extended QC’ applies to.
Controls in the ‘Aquila’ are processed in manual mode only. To access the QC panel, select the ‘Menu’ Tab

then press ‘QC menu’ button.

1

Figure 94 QCmain screen

1: QC measurement 2: QC references 3: QC results (and charts)

4: Blank

P a g e 119
From the ‘QC main’ screen user can initiate all tasks related to analyzer’s quality control. The functions
that available from this screen:
The operator can
 initiate the daily QC measurement by ‘QC measure’ button(1), see in chapter 10.2
 set reference values for a control LOT (2), see in chapter 10.1
 review the QC measurement diagrams (3), see in chapter 10.3

10.1 Setting QC Reference

Before performing any QC measurement, target values and acceptable ranges must be specified for a QC
lot of control material. Click or tap the ‘QC reference’ button (2) to open the ‘Set QC reference’ panel.
The opening list, displays the previously measured QC materials and their reference values ordered by
their LOT number:

Figure 95 Set QC Reference Panel

Click or tap the ‘Open’ button in listed QC material record and the detailed parameter overview
panel opens.
Note: For information purposes this function allows a review of previously entered QC LOT’s parameters.
By its nature, once a QC reference is defined, its ranges are unchangeable as it may influence the existing
QC measurement evaluation.
Target values, acceptable ranges and Extended QC of the control material should be set only once, i.e.
when you start using a given lot. Resetting parameters does not delete previous QC results of that level.
Any change in the QC reference ranges setting does not delete previous QC results. It is strongly
recommended to print QC results prior to changes.

By clicking or tapping on the ‘More’ button, the selected item can be deleted or edited.

User can return to ‘QC menu’ screen from the ‘Reference panel’ by clicking or tapping the button

P a g e 120
 Figure 96 QC LOT reference value WBC tab, review

QC reference values can be edited on this screen, which is separated to three tabs:
 WBC
 RBC
 PLT
Each tab has fields for entering information for reference parameters relevant to the tab selected:
WBC tab  WBC
 LYM
 MID
 GRA
 LYM%
 MID%
 GRA%
RBC tab  RBC
 HGB
 MCV
 MCH
 MCHC
 RDWsd
 RDWcv
PLT tab  PLT
 PCT
 MPV
 PDWsd
 PDWcv

These values cannot be edited, all action button and field remains inactive (grey). User can close this panel

by clicking or tapping the button.

P a g e 121
10.1.1 How to Create New QC reference table
When the actual control LOT expires, the User must create a new reference value set to continue QC
check. To create a new reference entry for new QC LOT material, click or tap the press ‘New ’
button on the QC reference list. (See previous figure)

1 2 3

4
6

Figure 97 Adding a new QC reference

How to set reference values manually:

Step 1. Enter the LOT number of control in the input field marked (1). This information is obligatory
Step 2. Select the control type (LOW/NORMAL/HIGH) accordingly (2), what kind of blood is used.
Step 3. Set the expiration date for the current reference set in the input field (3)
Step 4. Select the tab to display relevant parameter reference fields.
Step 5. Complete the obligatory parameters reference values such as: WBC, LIM%, MID%, GRA%, LYM,
MID, GRA, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, MPV, RDWsd, RDWcv, PCT, PDWsd, PDWcv,
depending on the tab opened at the time.
To enter data, the user can use the on screen keypad or external keyboard.
Pay attention to the indicated units on the screen. Use the values from control material assay sheet,
which can be recorded with two decimal accuracy. When entering decimals use the dot ‘.’ NOT
comma ‘,’ as separator. When modifications are finished, confirm changes with ‘Save result’

button (5) or abandon changes with pressing ‘Discard’ button (6). The QC reference screen can
be closed by the ‘Close panel’ button.
NOTE: If the reference values values are not correctly/fully completed in the table, it is not possible to
save the values and the next warning will be displayed:

P a g e 122
Step 6. Repeat the procedure for LOW, NORMAL and HIGH controls, from same LOT.
After these preparation steps, the analyzer is ready for QC measurement process (10.2) and the system
will consider the above set values.
Note: ‘Extended QC’ limit settings can be found in MENU/SETTINGS/System preferences window. The
process of updating the ‘Extended QC’ limits is detailed in chapter 8.1.3 System Preferences

10.1.2 Using a barcode reader to enter reference values

The Aquila high level software is able to recognize and accept the above reference values from barcode
reader. All genuine Diatron control/calibrator material have a printout, which contains the full assay
content coded into a 2D barcode.

Figure 98 The 2D barcode on Diatron control assay sheet

Step 6. Connect the reader to any of the analyzer USB ports.

Step 7. Go to any of the main screens. (Measure, Patient, Review, Menu)
Step 8. Read the code from control assay sheet or from computer display. If BCR successfully decodes
the 2D barcode, system emits a sound.
Step 9. After a few seconds, the reference values automatically appear within the reference editor
panel.
Step 10. Extended QC limits can be set turning its switch on (item 4 on Figure 90).
Step 11. Press ‘Save’ , if displayed information and LOT name is correct. NOTE: a reference
set cannot be saved if a LOT already exists with same name. In this case rename the new LOT manually.
The QC reference screen can be closed by the ‘Close panel’ button.

P a g e 123
IMPORTANT: To compare entering data manually - where each and every LOW, NORMAL and HIGH
reference values must give one by one-, the barcode reading method transfers all assay data for all level
at once.

10.2 Performing a QC Measurement

To run a QC measurement, please ensure that a valid blank measurement has been run and accepted. The
QC measurement results will be added to the QC database and associated with matching QC material lot.

Control/calibrator material and sample tubes should be handled as a potentially biohazardous

material. All applicable laws, regulations and laboratory practices should be followed in the handling
and disposal of calibrator materials.
Make sure that the actually used control LOT reference values are already recorded.
Step 1. Prepare a sample tube with calibrator material. Ensure that there is sufficient sample volume for
measurement. (See approved controls under 3.1.2)
Step 2. Place the control sample tube in the sample door.

Step 3. Click or tap the ‘QC measure’ button (1) on the ‘QC’ function screen.

Figure 99 Starting QC measure

Step 4. Give a sample ID if a unique measure name is required (this optional) or activate the ‘Auto
increment’ switch. In the latter case the measurement will be identified as QC_xxxx. For more
information about sample identification see chapter 6.8.1
Step 5. Select ‘LOT number’ for the actual calibrator. The reference values for this LOT must exist before
this measurement starts. (See setting QC reference, 10.1)
Make sure again now, that the sample is inserted.

Step 6. Click or tap the ‘Measure’ button to start measurement process. A temporary screen will be
displayed: “ANALYSING” while the measurement process is on-going.
Step 7. At the end of measurement the result of this QC measurement is displayed:

P a g e 124
 Do not remove yet the control sample from analyzer when it is returned.

Figure 100 QC measurement result screen

Step 8. Click or tap the ‘Review’ button if result is acceptable (no warning flag, no parameter range
flag, results fit to assay values) or press ‘Next measure’ to repeat this QC measurement. To make the

operators’ task easier, the QC result screen displays an evaluation flag ‘IN RANGE’ if all the values
are within the expected ranges. Another possible outcome of a QC measurement, when a red warning
‘OUT OF RANGE’ is displayed. The QC result screen can be closed by the ‘Close panel’
button, returning to ‘QC menu’ screen.
Note: In case of enabled Extended QC function the parameter name which is not in the extended QC range
will be displayed with red letter to indicate the out of range result. The out of range indication flags (H/L)
are also displayed, printed and sent to LIS.
Now user can remove control vial from analyzer.

Optionally the user can print QC measurement results using ‘Print’ button.
This result screen displays only the eight most important parameters such as counted WBC, LIM, MID,
GRA, HGB, RBC, MCV, PLT. If operator needs wider range of information go to Step 9.

Step 9: The user can open the detailed view of this current measurement, by pressing the ‘Review’
button. The detailed result view (Figure 62) is fully discussed in chapter 7.3. Please refer to this chapter
for further information.

10.3 Evaluation of QC results

To enter QC evaluation screen click or tap the ‘QC review’ icon (3) on the ‘QC menu’ screen. The
purpose of this feature is to generate and overview the QC diagrams about a specific QC LOT. The below
review panel opens:

P a g e 125
 1 6

2
5

7
5

Figure 101 QC results screen

1: LOT selector 2: List of Measurements 3: Preview charts

4: View charts 5: Detailed view (single) 6: More features
7: Open results

As a default, no results are displayed so to select a LOT number (1) first, is a must. The LOT number, which
is in the focus of the interest, can be selected via a drop down list. The actual results are displayed as list
of items on the left region of the screen (2).
As the interface is interactive, the user can select/unselect measurement items by the usual way on the
measurement record listing area (2). A diagram preview will be calculated and displayed onto right side of
the screen (3) after pressing ‘Draw charts’ button. Note: the ‘View charts’ feature is
inactive until ‘Draw charts’ is pressed at least once. Status changes are indicated by turning buttons blue.
User can return to ‘QC main’ screen by clicking or tapping the button.

To have a full parameter overview of the diagrams, click or tap onto ‘View Charts’ button.
The below diagrams will be displayed where green line shows the Extended QC limit:

Figure 102 QC charts

P a g e 126
The user can scroll up/down with scrollbar (1) (or swiping) between the charts. Each diagram contains (left
side) the
Name of the parameter.
Target value (reference) and allowed deviation
Mean value (measured)
StDev: standard deviation as calculated
Cvar %: calculated variance in percent
N: the number of data, the above results were calculated from
The following hematology parameters are tracked : WBC, LYM, MID,
GRA, RBC, PLT, MPV, HGB, HCT, MCV, PCV, MCH, MCHC, RDWsd, RDWcv

The limits on the chart are gold for the parameters defined by the control assay sheet, and green for the
ones ‘Extended QC’ is applied to.
The Aquila user interface provides a more detailed view of one chart when a diagram is displayed onto
screen. Just click or tap the chart’s region and view is switched to one chart per screen resolution.

Return to ‘QC results’ screen clicking or tapping the button.

10.4 How to enable/disable Daily QC request

The Aquila system allows to an ‘Advanced’ or higher access level user to configure the daily QC
measurement request or to deactivate it.
Step 1. Enter system as Service user. Maneuver to the following path: ‘Menu Tab’ -> ‘Settings’ ->
‘Service Settings’ ->’Other Settings’.
Step 2. The below configuration panel opens:

Figure 103 Daily QC requirement settings

Step 3. Select the required QC restriction setting from the dropdown list :

P a g e 127
 Setting Effect
No check With this setting, the system can be used for any kind of measurement
without having valid QC result for current date.
One level With this setting, the system cannot be used for human sample measurement
without having first a valid NORMAL level QC result for that current date.
Three level With this setting, the system cannot be used for human sample measurement
without having first a valid result for LOW, NORMAL and HIGH level as well,
for that current date.
Step 4. If the second or third of the above options is set, the system will display the following warning
on any attempt of a human sample measurement:
Measurement is not required under the following conditions:
o No QC measurement had been run that day or since the analyzer had been turned on, or
o A QC measurement had been run that was in range
If a QC measurement had been run and the measurement had failed, the following window appears
when initiating a patient measurement:

By pressing the ‘GO TO MEASURE’ button, system drives directly to QC screen.

Close this configuration panel and return to settings by clicking or tapping ‘MAINTENACE’
button.

P a g e 128
 11 The Patient database
The ‘Aquila’ analyzer provides creation and storage of patients in the local patient database. These
database items can be optionally assigned to a currently measured sample during measurement workflow
(more about how to create or assign a patient to sample refer to chapter 6.5.4).
Patients can also be pre-defined for later use during a measurement process. This chapter describes
handling and maintenance of the patient database.

To access this table for maintenance purpose or to add a new patient, simply open ‘Patient’ tab
(Figure 104). The below ‘Patient’ screen opens:

3 4
2
1
3 5
2
1
3
61
13
32
22
1
3
1
3
2
1: Patient Searching tool 3: Add a new patient button
2: List area 4: Print patient list
5: Additional functions (Edit, Delete) 6: Multiselect switch
Figure 104 Patient table

11.1 Adding a new patient to database

After opening the patient table, simply click onto the ‘Add patient’ button (3). A new
patient data form opens to allow completion of patient attributes (see below).
The obligatory data fields are framed with red, meanwhile the ‘Save’ command remains inactive. Any
unacceptable input data is indicated in a red framed input field. The operator should correct value
according to the data type required by the attribute. Invalid data will not be saved.
Data input can be made either on the screen keypad or on an external keyboard.

P a g e 129
 Figure 105 Add a new patient form

For patients the following attributes can be stored in the database:

ATTRIBUTE NATURE DESCRIPTION

PATIENT ID Obligatory Freeform character string, max 30

FIrst name Obligatory Freeform character string, max 50
Last name Obligatory Freeform character string, max 50
Gender Drop down, optional Undefined (default), MALE, FEMALE
Title Optional Freeform character string, max 15
Date of birth Obligatory, date type Use the method as explained in 5.4.11 chapter
nationality Optional Freeform character string, max 40
country Optional Freeform character string, max 60
city, Zipcode Optional Freeform character string, max 65
Address Optional Freeform character string, max 100
Table 16 Patient attributes

Complete the attributes as required. Obligatory fields framed with red color. After finishing the operation
confirm changes by clicking or tapping ‘Save’ button or discard changes by clicking or tapping on

‘Discard’ button. The ‘Save’ button becomes active only when all necessary fields are
completed. New patient record is now ready for further use.

11.2 Editing an existing patient record

Select a record from list or use the search tools, - see (1) Figure 104 Patient table - to find a patient who is
the subject of the interest. Search conditions could be the ‘Patient ID’, ‘First name’, ‘Last name’. Type
relevant information to any of these fields then press the blue ‘Search ’ button.
If the search is successful, the relevant hit(s) are listed in this same window. (More details about Search
features can be found in the next chapter, 11.3)

P a g e 130
 To edit a specific patient attributes, first select it, by tapping on the record. The selected state is indicated
by blue background color. Click or tap on ‘More’ button (5), then select ‘Edit’ from dropdown
list. As a result, the below form opens:

Figure 106 Edit patient form

On the input fields the small grey ‘X’ cross indicates the field is not empty. Any unacceptable input data is
indicated with a red frame around, at time when its entered. Any modification has to be made in
accordance to the data type required by the attribute. (See above, Table 16 Patient attributes)
Click or tap onto the attribute field which automatically opens for data input and the keypad appears on
the screen.
Modify the attributes as required. After finishing the operation, confirm changes by clicking or tapping

‘Save’ button or discard changes by clicking or tapping on ‘Discard’ button. After finishing the
operation, the software returns to list view of patients.

11.3 Searching for a patient

Operator can search for a specific patient using the tools and input fields marked as (1) on Figure 107. The
permitted search parameters are Patient ID, First name, Last name. Even single or multiple conditions can
be set. Start action by clicking or tapping the blue ‘Search’ button.

1
3
1
3 Figure 107 Search for a patient
2

P a g e 131
 The displayed results are those patients, which Patient ID or First name or Last name beginning
corresponds to the search keys entered. The condition is not case sensitive, filtering by lowercase or
uppercase results in the same hits.

11.4 Deleting patient from database

Single or multiple elements can be removed from Patient table. Only those records can be deleted, that
has no relation with measurement. Select single record by simply clicking or tapping on it.

For distinctive or group selection use the ‘Multiselect’ switch (6) (left upper corner of the list).
Click/Tap once on it, then it changes to . This allows any record to be selected individually by
clicking/tapping anywhere in their row. As a result, the selected items background changes blue.

To select a whole set of displayed records, click/tap once again onto the (already) active ‘Multiselect’
switch. As a result, all list item becomes ‘Selected’ state, meanwhile the ‘Multiselect’ switch changes to

. Clicking once again (third time) on it, the full selection is cleared and the default state of
multiselect switch is restored.
To complete deletion process click or tap on ‘More’ and finally the ‘Delete’
buttons. User must confirm the deletion before operation is completed.
(see illustration left)

P a g e 132
12 The Multi-User Mode
The Aquila analyzer can be operated by authorized users only. These accounts can operate the different
functions of the analyzer depending on their access rights. The multiuser mode allows laboratories to
operate analyzer within safe conditions and protect the results and database from accidental erase.
The multi-user mode also provides the audit tracking of any activities in the event log by recording the
user ID of the currently logged on user.
Accordingly, the available screens and features also depend on the user access level.

12.1 Users and Roles

The system user‘s access right structure is built up as the below illustration shows:

User Account Role Privileges

Figure 108 Aquila user account right assignment

One user can own one and only of the – currently available three - roles, meanwhile one role consists of a
set of system privileges. Privileges define the feature(s) or the available action(s) within the analyzer
software. Example: to start a QC measurement is a privilege.
The user accounts: no limit of created number of users. By default, the Aquila analyzer has:
Account name Description
Admin no default password, user can freely change
can reset own and all other users’ password that created by the Admin
can add user
Service has a default password
can reset any user password on analyzer
can add user

The roles which can be assigned to analyzer users:

Role name Description
Admin Manage users; set network parameters; view/edit/delete measurement and patient
records; perform maintenance functions; running diagnostic functions; running all
measurement related functions;
Advanced perform maintenance functions; running diagnostic functions; running all measurement
related functions; view measurement, edit/delete only patient records; changes on basic
analyzer setting only
Basic performing blank, human and QC measurement; edit/delete only patient records;
measurement result export.

NOTE: some of the built-in roles (Service) cannot be edited or deleted by the operator, therefore these
are not displayed as available role.

P a g e 133
12.2 Managing Users
For those users who are entitled to access it (by default: the ‘Admin’), the user account management

features are available behind the ‘Menu’ Tab, under ‘User management’ button. By
clicking or tapping this, the below screen opens:

.
1: List of existing users 2: Reset password 3: Add new account
Figure 109 User administration functions

12.3 How to add a new Analyzer User

To add a user, click or tap on the ‘New user’ button. As a result, the below editor panel
opens:

1 3
2 2

1: New username input 2: List of roles 3: Save button

Figure 110 Add new user panel

The sample IDs created will be formed when following the naming convention below:
Step 1. Enter a new user account name to the input field (1)

P a g e 134
 Step 2. Assign a role to the new user (2) by putting a checkmark to the required role
Step 3. Save changes by clicking or tapping the ‘Save’ button (3)
Step 4. Add a password for new user by typing it into the below input form:

Step 5. Press ‘SAVE’ to confirm the changed password.

Step 6. The Login window comes up. Log on your user name and password again.
The creation of a new analyzer user is complete now.

12.4 How To Edit An Existing User

Open the user manage screen by clicking or tapping onto ‘Users’ button (2) on the Menu screen. As
a result, the below panel opens:

3
3
1

1: User account list 2: Add new user 3: Edit user button

Figure 111 Manage user screen

The actually existing analyzer users (1) are listed by the date of creation. Operator can add a new account
by tapping the ‘New user’ button. This opens the previously discussed ‘Add user’ panel
(12.3). By clicking or tapping the ‘Edit’ button on any of the list items, the user editor seen
below opens:

P a g e 135
 1 3
2 2

5
2
2

1: Current username 4: Reset password

2: List of roles 5: Delete user
3: Save button
Figure 112 Edit user panel

The currently edited account name is shown in ‘Username’ field (1). In the list area (2) the assigned role is
shown. The effective role is colored and for better visibility a checkmark also displayed.

The operator can change a role by selecting/deselecting the checkmark button in the displayed row.
Further operations that can be conducted here:
 The operator can reset user password by clicking or tapping the ‘Reset password’ button.
 An account can be deleted by clicking or tapping the ‘Delete user’ (6) button.
 Save changes by clicking or tapping the ‘Save’ button (3) or abandon all changes by closing
this panel

Closing editor occurs by clicking or tapping the . When this editor is closed, the user manage screen
(Figure 111) appears again and finally operator can return to ‘Admin’ screen by clicking or tapping the
button.

12.4.1 How to set/reset a user’s password

Step 1. Enter system as ‘Admin’ or ‘Service’
Step 2. Open the user property editor screen (Figure 112 Edit user panel)
Step 3. Clicking or tapping the ‘Reset password’ button

P a g e 136
 Step 4. Add old and new password by typing it into the below input form:

Step 5. Press ‘SAVE’ to confirm the changed password.

The password change confirmed by the below message:

Figure 113

Confirm the displayed information by clicking or tapping to ‘OK’ button. New password for user is now
set.

P a g e 137
13 Setting Parameter Ranges
The Aquila analyzer patient hematology parameters have pre-defined limit ranges. According to the
laboratory requirements, these pre-defined limits may be modified.

To modify these, open ‘Menu’ Tab (Figure 74) then click or tap on ‘Settings’ icon, and finally

click or tap on ‘Profile limits’ . The Profile limit editor opens:

1 2 3

1: Profile selector dropdown 3: Create a New profile

2: Edit existing profile
Figure 114 Limit ranges editor

As a default the following profiles are pre-defined and selectable from dropdown list (1):
HUMAN, MALE, FEMALE, CHILD, TODDLER, BABY
Each row in the list represents a hematology parameter with its low and high limits including critical range
limits. Low/high values are indicated identically and displayed by the following colored letters (L,LL, H,HH).
The RBC Human high profile limit is 8.00 and over 8.00 the out of linearity flagging will be applied on the
parameter. The HCT Human high profile limit is 60.0 and over 60.0 the out of linearity flagging will be
applied on the parameter.

P a g e 138
13.1 Editing an existing limit range
To make changes to the pre-defined parameter range table, first select a profile name from the drop down
list (1). Then press ‘Edit button’ (2). As result the editor page below opens (Figure 115):

1
4

2
3

1: Profile name 3: Reset values

2: Group selector 4: Save changes
Figure 115 Profile editor panel

For better visibility, the hematology parameters are grouped to WBC, RBC, PLT sets. (this area marked as
(2) on figure) Enter parameter limits accordingly. When modification is finished, confirm changes with

‘Save result ’ button or abandon changes with pressing ‘Reset’ . In the latter an additional
question appears (Figure 116):
User is asked to select the base profile which
values will be reset. (See figure left)
Confirm this action with ‘OK’ and profile editor
opens with current profile and previous limits.
User can abandon the reset operation by
‘Cancel’ button.

Figure 116

P a g e 139
13.2 Creating a new profile of limits

On the limit range overview screen click or tap on the ‘New profile’ button (3). The system
requires the operator to choose an existing profile which will be the basis of the new one. (Figure 116)
After confirming this selection with ‘OK’, the same editor panel pops up as described in the previous
subchapter (Figure 115). Do limit adjustments and give a name to profile by typing it into input field (1).
Finish the operation and confirm changes with ‘Save result ’ button. New profile is now created.

P a g e 140
 14 Instrument Diagnostics
The instrument diagnostics section allows the operator to perform diagnostic procedures, check the
operational history of the instrument, set or check the status of the reagents and view stored event

information about the system. To access this group of settings, open ‘Menu’ tab (Figure 74) then

click or tap on ‘Diagnostics’ icon. The new opening screen is the collection of the following diagnostics
functions:

1 6 4 5

1: Self test running 4: Analyzer statistics

2: Show system logs 5: About system
3: Reagent status 6: Run stress tests
Figure 117 The Diagnostic functions

Note: Device logging features available only for users with ‘Export’ privileges.

14.1 The About machine information panel

Click or tap on the ‘About Machine’ icon (5) on the ‘Diagnostic Screen’ (Figure 117) and the following
panel opens:

P a g e 141
 1
2
3 1
2 3
4
1 2
3
5
2

1: Device serial number 3: Lower board firmware

2: High Level software version 4: Bootloader version
5: Firmware versions
Figure 118 About machine screen

Return to ‘Diagnostics’ main screen by clicking or tapping the button.

14.2 Device Statistics

This screen displays cumulative information such as the number measurements and the number of other
events recorded during operation. Statistical data can be only reset by a Diatron certified service engineer.

Click or tap on the ‘Device statistics ’ icon (4) on the ‘Diagnostic Screen’ (Figure 117), and the following
panel opens:

Figure 119 Device statistics screen

The logged and counted event types which are listed on this screen, the number of:
Successful startups, Successful Shutdowns, Started Measurements, Completed Measurements, General
errors, Shear Valve Error, Sample Holder Error.

P a g e 142
Only a service or factory level user can reset statistics. Return to ‘Diagnostics’ screen by clicking or tapping
the button.

14.3 Reagent information

By clicking or tapping on the ‘Reagent ’ icon (3) on the ‘Diagnostic Screen’ (Figure 117) the following
screen opens:

Figure 120 Reagent status screen

(1) Illustrated display of the remaining number of measurements. This information is directly stored in a
smart chip which is integrated into bottle. This information is updated when a bottle is replaced.
(2) Reagent usability information is as follows:
- Reagent identifier
- Production LOT number
- Opening date
- Expiration date (allowed on board time)
N.B. All the above information is stored and read directly from the smart chip integrated into the bottle.
Return to ‘Diagnostics’ main screen by clicking or tapping the button.

14.4 Event log of the Analyzer

The system log provides information for service or troubleshooting purposes. It lists all events and possible
problems related to operation or measurements. Routine events such as a login and logout, as well as
maintenance operations (e.g. cleaning, manual prime of lyse and diluent) are also logged. If the multi-user
mode is enabled, the user ID of the operator that is logged at the time an event occurs will also be stored
with the log entry. The analyzer periodically (every 365 days) removes old logs. Click or tap on the ‘Log ’
icon (2) on the ‘Diagnostic Screen’ (Figure 117), and the following panel (below) opens:

P a g e 143
 1 2

3
4

4
5

1: Listing start date 3: Export log file as .csv

2: Listing close date 4: Export all events into collect file
5: Print log 6: Open selected item
Figure 121 Device log screen

The Aquila analyzer stores and logs all application and device events. In the event log viewer panel (Figure
121) user can filter the displayed entries by their occurrence date (1) and (2). As a default, the last day’s
events are displayed. The logged events can be exported into .csv files compressed in a .zip archive (3) or
a special collection file (4). A .collect file contains the last seven days of .csv logs prior to collection.

The log entries currently displayed can be exported using the ‘Save to csv’ and ‘Export Collect File’

action buttons. For more information about using export function and these export formats refer to
chapter 7.4.3.
The default export name mask for a .csv export file: A1Log<dd.mm.yyyy_hhmmss>.csv
The default export name mask for a collection file: Export<dd.mm.yyyy_hhmmss>.collect. Collection file
serves for factory diagnostic purposes, viewing its contents requires a special utility software.

By Clicking or tapping the ’Print’ button (5), on the screen, it sends the whole report to the system
printer. Note: Event log printing option is not available by Zebra ZQ320 thermoprinter. Please select
alternative printer in Menu/Setting/Printer setting window. see: chapter 8.1.5 Setting up a system Printer

Return to ‘Diagnostics’ screen by clicking or tapping the button.

14.5 Analyzer Self Test

On the ‘Diagnostic’ screen, the ‘Self test’ action button initiates the internal test process on the
analyzer electronic and fluidic system. After pressing the button, the following panel (below) opens:

P a g e 144
Note: by default this screen is empty, after running a ‘Full’ or ‘Fast’ self test, the result screen will be
populated as illustrated on Figure 124.

Latest test result can be call up to screen by pressing the ‘Load Last Self test ’ action button.

Figure 122 Self test opening panel

Start test process by clicking or tapping the ‘Full test’ button. The process takes approximately one
minute, while the below screen is displayed (Figure 123). The test includes all electronic and pneumatic

components. The ‘Fast test ’ button initiates electronic component test only.

Figure 123. Self Test on running

At the end of test cycle, the following screen will be displayed:

The full list is very long, so the manufacturer suggests to save it to external device for further diagnostic
purposes.

P a g e 145
 Figure 124 Self test result display.

Click or tap the ‘Done’ button if the result is acceptable or press ‘Rerun’ to repeat self test
procedure. To make the operators’ task easier, the self test displays ‘Passed’ for acceptable result
and ‘Failed’ if any of measured values are out of allowed operational range.

Optionally the user can print self test results or export them to text
format by pressing ‘More’ button, which reveals the following
context menu (see right). Before saving the results, insert a
removable storage to any USB slot.
The full self test result screen can be closed by the ‘Close panel’
button, returning to main ‘Diagnostic ’ screen.

14.6 Performing stress measurement cycle

The stress measurement is a manually forced single or multiple cycle(s) of a blank measurement(s). Use
this function to clean and troubleshooting purposes. To start this function, click or tap on ‘Stress measure’

button (6) on the ‘Diagnostic Screen’ (Figure 117), and the following input form is displayed. The
opening new panel requires operator to make the following choices:

P a g e 146
 1 2

Figure 125 Stress measurement start screen

First, define that ‘Continuous’ or a limited number of measurements will be performed. Activating the

‘Continuous measure’ switch (1), automatically eliminates the cycle counter input (2). Then click
or tap on ‘Start ’ button (3). After, the defined number of stress measure will be executed. After each
completed blank measurement the current WBC, RBC, HGB, PLT values are displayed row by row. This
ensures the operator to observe the tendencies of the parameters. For example, the PLT drops down as
expected at blank measurement.
If an infinite or limited number of measurements were defined, the process can be stopped anytime by
the ‘Cancel’ button, which is only displayed when the process is on-going. The current run results are
saved automatically.

Optionally, the user can load last stress measurement result list using ‘Load last stress’ button (4).

Results can be saved to an external storage by using ‘Export’ button.

The stress result panel can be closed by the ‘Close panel’ button, returning to main ‘Menu’ screen.
NOTE: Each stress measurement decreases the number of available credits so please be cautious when
starting a continuous cycle (1) not to exhaust reagent volume or number of credits.

P a g e 147
 15 Maintenance of the Analyzer
To ensure reliable operation, regular maintenance of the measuring and fluidic system is required by the
operator. This chapter describes the necessary procedures and steps required to keep your analyzer in a
good daily operating condition.
There are, however some regular maintenance actions that only trained service personnel are allowed to
do. These procedures are described in Diatron Aquila Service Manual.

Any components inside the analyzer such as tubes, valves, chambers, containers should be handled
as a potentially biologically and chemically hazardous material. Observe local laws and regulations
regarding handling and during disposal.

Click or tap on the ‘Maintenance’ icon on the ‘Menu’ main screen and the ‘Maintenance’
panel (Figure 126) opens with the following available functions:

1 2 4 5

1: Cleaning 4: Needle cleansing

2: Hard cleaning 5: Aperture clean
6: Reagent priming functions
Figure 126 Maintenance features (standard user)

For standard operators (without service privileges) the above functions are available only (Figure 126):

FUNCTION WHEN TO USE

Cleaning (1) To provide low PLT background, keeping analyzer clean condition. Cleans
both measure chamber by diluent
Hard Cleaning (2) For needle and blood path decontamination. At least weekly once or after
50 measurements
Aperture cleaning (5) WBC aperture cleansing. Use right after when ‘C’ or ‘c’ flag appears or
when WBC/RBC/PLT blank is elevated
Needle Wash (4) Occasional cleaning on needle surface

P a g e 148
Prime diluent/ Lyse (6) These functions provide the operator to execute prime manually in case
the reagent sensor would not work and automatic prime could not take
place. They are used mainly for maintenance or troubleshooting purposes.

There are several additional feature of low level diagnostic and troubleshooting purposes. These features
are discussed in details only in the service manual.

15.1 Maintenance Functions supported by Software

Cleansing functions help to keep the ‘Aquila’ analyzer clean and good operating condition. As Diatron
Aquila system does not have online cleaner solution connected, inserting external Hypoclean solution
(D8014) is occasionally needed. The different software supported cleansing features are discussed in the
next chapters.
If blank measurements do not return to normal after the ‘Clean’ or ‘Aperture clean’ software maintenance
functions and after running several blank measurements, please contact your Diatron certified service
engineer for additional assistance.

15.1.1 Cleaning process

In addition to the normal chamber washing cycles during the measurement process, the ‘Cleaning’
maintenance function is available for operator to perform a thorough rinsing of the system tubing and
pneumatic components.

Click or tap on the ‘Maintenance’ icon on the ‘Menu’ main screen, and the ‘Maintenance’
panel (Figure 127) opens to providing the below cleaning methods:

 ‘Cleaning’, start icon marked below as (1)

 ‘Hard cleaning’, start icon marked below as (2)
 ‘Aperture clean’, start icon marked below as (4)
 ‘Needle Wash’, start icon marked below as (3)

1 2 3 4

Figure 127 Cleaning functions (for standard users)

P a g e 149
After pressing the ‘Cleaning’ button (1), a non-interactive process starts and the analyzer hydraulics
perform a cleaning cycle with diluent. The whole fluid system and both chamber is affected. This
procedure is recommended occasionally if background values are elevated or clogging suspected. This way
the tubing, measurement chambers and shear valve will be washed through and protein remnants will be
removed. The Aquila analyzer is using diluent for cleansing.

15.1.2 Periodic Cleaning with HypoClean

In order to avoid depositing contaminations and clogging the tubes, a ‘Hard Cleaning’ must be performed
after each 50 measurements. A pop-up message will appear after each 50 measurements to warn the user
about this maintenance. Following a reagent pack replacement, a hard cleaning must be done, too.
The analyzer outer surface can be contaminated by blood drops. To remove, use a soft wipe wetted by
non-abrasive detergent.

15.1.2.1 How to prepare the vial for hard cleaning

The DRP074 reagent pack is bundled with a 100 ml bottle of the Hypoclean CC cleaning solution and
empty vials to be used for the cleaning procedure.
Prepare the vial by transferring approximately 4 ml of the cleaning solution into the empty vial, either by
dispensing it using a pipette, or by pouring it carefully.

Figure 128 Empty vial

Once the vial is prepared, it is ready to be inserted into the analyzer.

Figure 129 Insertion of the Hypoclean CC cleaning solution

P a g e 150
 15.1.2.2 How to perform the periodic hard cleaning
This procedure serves for needle decontamination and removing protein remnants from sample path, Mix
Chamber and WBC Chamber. It cleans the apertures with High Voltage burst as well. Before starting this
process prepare the following items:

 Diatron D8011 Hypoclean CC reagent

 Empty vial from DRP074 pack, prepared as instructed
CAUTION: Hypoclean CC is a highly corrosive and irrigative fluid, wear personal safety protection
when performing this operation to avoid skin injury

Press the ‘Hard clean’ button (2) on the maintenance screen (Figure 127) then follow the instructions
on screen:

Figure 130 Hard cleaning

Analyzer will draw about 0,55ml cleaning solution (Diatron D8011 Hypoclean CC) from a sample vial. This
chemical will be pass through the sampling needle, Shear Valve funnel and metal loops; filling into Mix
and WBC chambers before being diluted. After a few minutes wait, it is flushed out regularly, then a
cleaning cycle is executed automatically

Rubber sample caps are not designed for multiple punctures. The Diatro•Hypoclean CC reagent will
cause the rubber vial cap to harden, releasing small particles that can clog the analyzer. Always
remove the rubber cap when performing daily cleaning.
If the blank measurements do not return to normal after performing the ‘Clean’ and ‘Hard clean’ software
maintenance functions and running several blank measurements, please contact your Diatron certified
service engineer for additional assistance.

15.1.3 The Aperture Cleansing Function

Press the ‘Aperture clean’ button (4) on the maintenance screen (Figure 127) then wait till process
finished in a few seconds.
The ‘Aperture cleansing’ takes effect on WBC and RBC chamber apertures. Both fluid rinsing and high
voltage impulses applied on these apertures to remove protein remnants.
This procedure is recommended occasionally if WBC/RBC/PLT background value is elevated or execute
right immediately when a measurement is flagged with ‘C’ or ‘c’ which is indicating aperture clog.

P a g e 151
15.2 Manual Cleansing Of The Needle Washing Head
Amongst the automated software controlled cleaning procedures, after time the bottom surface of the
needle wash head needs to be cleaned due to the sample blood residues and salt. This procedure requires
the user to manually clean a component inside the analyzer.

Any component inside the analyzer including the needle washing head, should be handled as a
potentially biologically and chemically hazardous material. Always wear personal saftety
protective gloves and eye protector during this procedure.
The cover of the analyzer does not need to be removed. Follow the procedure below:

Step 0.
Prepare the following items for cleansing:

 Distilled water
 Cotton buds
 Wet wipe
 Soft brush, optional to remove salt built-up

Step 1.
Wake up system to online state, the sample door should
be open.
If system is in standby state, touch the “Closed” indicator
on the
Status bar. This illustration shows the proper condition to
continue

Step 2.

Touch and hold the opened sample door, to prevent it

from closing.

P a g e 152
 Step 3.
Touch the screen “Door control” region which indicates
now “Open”
By clicking or tapping on this indicator sends the sample
holder inside.

Step 4.
Hold back the outer cover of the sample door, meanwhile
the sample moving unit returns into the analyzer . Now
the access to needle washing head is provided through
the door gap.

Hold the door at about 45 degree angle. This provides

sufficient space to reach the washing head over the door.

Step 5.
Reach in and clean the bottom surface of the washing
head with a wet cotton bud. Repeat the action until the
bud remains uncolored.

Step 6.
Finish the cleansing action with a wet wipe.

P a g e 153
 Step 7.

Touch the door control region of the Status Bar which is

displaying now the “Closed” status. This drives system
again to “Open” state, returning the sample holder again
to the front.

Step 8.

Perform a Blank to make sure the system is clean.

System now is ready to continue.

The materials used during the procedure must be handled as potentially hazardous waste as cleaning
materials contain blood components. They should be considered as infectious material so always
wear personal safety protectives when handling waste. Always follow local laws and regulations
governing the disposal of hazardous waste.

P a g e 154
15.3 Replacement of the Reagent Pack
The Aquila analyzer is designed to be able to run approximately 200 cycles on one bottle of DRP07 reagent.
The final number of available measurements per bottle strongly depends on the usage circumstances. See
more about the consumption characteristic at chapter 18.2 Reagent Consumption.To follow the reagent
level easily, the level indicator is continuously displayed on the status bar of the GUI.

Figure 131. Reagent Level Indicator Panel

The operator can obtain more information by opening the reagent status screen, see more about this at
chapter 14.3.
To replace a reagent container, follow the steps below:
Step 1. Prepare the new DRP07 container from the DRP074 pack and place it near the place of operation
Step 2. Shut down analyzer regularly. Open the reagent bay cover.
Step 3. Detach the reagent connector head. Clean up the surface of reagent connector from waste
residuals with a wet wipe. Wear protective gloves during this process.
Step 4. Close the used bottle by the sealing ring first, then put the new reagent bottle’s cap to it. Remove
the used container holding by its cap. Note: the bottle weight is about 3 kg, hold it safely when lifting
it up.
Step 5. Install the new reagent bottle by reversing the procedure. Connect the reagent head carefully to
the new smart pack. The manufacturer suggests to put cap and sealing ring aside the container in the
reagent bay for later use.
Step 6. Switch on the analyzer and let it to start up. Check the head connection again, the new credits
already should appear on status bar.
Step 7. The software automatically notices the pack change and initiate prime diluent and lyse to fill up
the reagent lines. As a final step of the process initiate a blank measurement before continuing with
QC or Human analysis.
Step 8. Dispose the used containers in accordance with local waste disposal regulations
Always follow local laws and regulations governing the disposal of hazardous waste. As
waste contains blood components, it should be considered as infectious material so
always wear personal safety protectives when removing waste.

15.4 Shearvalve release procedure

This chapter discusses the maintenance actions in the event that the analyzer shear valve becomes stuck
and a warning appears. N.B. It is advised to execute this procedure during the initial installation of the
analyzer The release of the shear valve does not require service intervention or removal of the cover of
the analyzer.
The manufacturer has built in an access point to fluidic system, which allows rinse fluid (distilled water) to
be pumped directly into the shear valve. This will dissolve any salt bridge formed during an extended
period of inactivity and lubricate the surface of the ceramic disks.
Note: this line has no any connection to sample processing path.
Situations when the shear valve can stuck:
- System is not in use for days without rinsing it (conducting prepare for shipment procedure)

P a g e 155
 - System is stored for a long time and the shear valve surface becomes dry
The system indicates the problem by the following error message:

Figure 132 When shear valve rotation is stopped

Following the procedure below helps to solve the problem of a sticking shear valve:

Step 0.

The shear valve rinsing terminals are located in the

reagent bay. The diameter of the lines are 2,27 mm, each
labeled IN or OUT. These terminals provide the temporary
connection to a syringe and return the rinse fluid from
shear valve

Step 1.
Accessories for procedure:
- A cup for the returning rinser
- distilled water, maximum 50 ml
- A 5 -10 ml volume syringe (enclosed)
- Interconnection silicon or PVC tube, 8 cm
Internal diameter ~2 mm. (enclosed)

Step 2.
Connect the 8cm length silicone tube to the syringe. This
will be the connection to the shear valve rinsing tube.
Load 5 ml distilled water into the syringe.

P a g e 156
 Step 3.
Pick the shear valve rinsing terminal labeled IN and
connect the syringe to the fitting.

Note: make sure to use the lines according to their

labeling. Only the IN rinsing terminal is equipped with a
fitting.

Step 4.
Place the other rinsing terminal (labeled OUT) into the
waste cup.

Step 5.
Slowly inject the full volume (5 ml) of the distilled water
in 1 ml increments (approximately 10 seconds/ml) into
the IN shear valve rinsing terminal. Increase the pressure
carefully and gradually while monitoring the liquid that
returns to the waste cup.

Caution: Administering liquid with sudden pressure

may damage the internals of the instrument!

Step 6.
Confirm the action finally by pressing “ START
RECOVERY” button to repeat the pneumantic system
initialisation.
DI water can be injected into the shear valve rinser
terminal during the recovery process.
User can repeat the rinse procedure from Step3, if first
attempt unsuccesful to operate the shearvalve

15.5 Cleaning Aquila outer surface

The Aquila analyzer surface can be contaminated by reagent drops or other substances during normal use.
Manufacturer recommends using the following techniques to remove these remnants:
- Always shut down the system by shutting it down first, then switching it off by the rear flip switch.
This way the sample door will be safely closed.

P a g e 157
 - Use soft, wet wipe drenched with non-abrasive detergent, or
- Use commercially available disinfectant cleansing wipe (i.e.: sodium hypochlorite wipe)
Method: gently rub the Aquila outer surface with the wet wipe until the contamination removed.

NOTE: do cleaning only when analyzer is fully powered off by the rear side flip switch.
If the system is left in standby state, the operator can accidentally power on the system during
cleaning.

P a g e 158
 16 The Daily Routine
In this chapter, a typical daily routine is described. Your daily routine may differ from the one described
here. The description below assumes that the laboratory/user works during a single daily shift only.
The daily routine:
 Power-up and start-up the ‘Aquila’ analyzer (see details chapter 5.2.1)
 Perform the pneumatics initialization by a blank measurement
 Collect the patient blood samples
 Ensure that the correct anticoagulant tubes (K3-EDTA) are used
 Ensure that the samples ages are within the 7 hours of time window
 Perform the QC procedure as scheduled (see in chapter 10.2)
 Start the measurements (see chapter 6 for details)
 Validate and release the measurement results according to your procedures
 Perform any necessary maintenance
 Shut down the instrument (see chapter 5.3 for details)
 Clean the instrument surface from blood contamination
16.1 Notes for daily routine procedure
Blank measurements:
 If you want to check whether the reagent path was contaminated during reagent container
replacement, then perform 4 to 5 blank measurements before accepting the blank result. If you
receive the samples in batches and more than 2 hours have elapsed between the last sample of
the previous batch and the first sample of the next batch, then it is a good practice to repeat the
blank measurement.
Quality Control:
 Perform QC measurements according to your local regulations.
 Monitor the expiration date and stability after first use of the QC material.
 If there are more than one hematology instruments in your laboratory then it is also a good
practice to measure the same human sample across all the instruments to compare their
performance. Use multiple parallel runs to reduce the effect of random error (CV%).
 We suggest performing at least one blank measurement before starting QC measurements.
Calibration:
 Calibrate the ‘Aquila’ according to laboratory regulations.
 Calibration should be performed with every new control material lot, or if QC results or
comparison of results to other instruments shows significant deviation in measurement results.
 If you perform a whole blood measurement calibration, it is recommended to run a blank
measurement before the calibration procedure (see chapter 9).
Cleaning: Perform aperture cleaning then washing head cleaning if:
 High blank results are experienced
 Clogging related flags are consistently appearing with measurement results
 After service actions or service level maintenance
 Measurement results or QC results are drifting (perform hard cleaning)

P a g e 159
17 Troubleshooting
Your ‘Aquila’ provides all the necessary software maintenance functions required to keep the analyzer
operating in optimum working order. Despite excellent maintenance, the analyzer can still encounter
problems where operator intervention is required. The ‘Aquila’ analyzer software informs the operator of
situations when further help is required. These are called error messages.

Only Diatron certified service personnel that have received Aquila service training can resolve
major problems that occur during operation. Electrical and moving parts should always be serviced
by trained service personnel.

The Aquila’ analyzer provides additional information in the form of numerical codes that help the operator
to identify the root cause of the error. These error codes are important for service personnel. They can
interpret the messages and take necessary actions.
If you receive error messages with codes, please write them down. If possible, describe what you were
doing before the error appeared. This important information helps your service engineer to help you when
necessary. The software will store and re-display every error message, but it cannot describe the operation
you were performing at the time.
When an error comes up, the software usually attempts to offer a solution, or will try to resolve the
problem and retry the current operation. If this recovery process fails, or the problem continues to occur,
please contact your service engineer.

17.1 Software error messages

If Windows operating system error appears, please accept the error message and repeat the
operation. If similar error occur again, please restart the ‘Aquila’ analyzer. At the next service visit,
please let the service engineer know about the problem.
Low level error messages provide status information about the data acquisition system and pneumatic
system. Each error message includes the affected part and the area of the equipment. Check this area and
part to find any irregularities like clogging, mechanical problems or blocked elements. Try to repeat the
operation. The system will try to recover from the failure. If the error continues to occur, please contact
your service personnel.

17.2 Pneumatic error messages

The analyzer software is designed to be error tolerant and recover from with minor problems. However,
in some physical obstructions or extreme operating conditions cause some mechanical parts to behave
unexpectedly

17.3 Mechanical Problems

Most mechanical problems arise because of some physical blockage of the moving parts. Problems caused
by severe blockages are usually accompanied by a grinding noise. The noise is a result of a motor not being
able to move, but this does not usually result in mechanical damage to moving parts.
Typical failure situations can be traced to salt build-ups around the wash head or the shear valve. Incorrect
operation during cleaning of the system, especially after long inactive periods of time can cause valves or
tubes to get filled with dry salt deposits. These problems can be the source of dilutor motor noise.

P a g e 160
In extreme tube or valve clogging situations the pressure build-up inside the dilutors can cause some tubes
to be released from their connections. This symptom is not normal, but will not cause damage to the
system. However, it is recommended to contact your service engineer to determine the cause and resolve
the problems.

17.4 The Analyzer Would Not Prime Liquids

 Check the reagent head smooth and tight connection.
 Repeat priming
 The respective reagent is out. Check reagent level, replace DRP07 pack.
 Damaged tube in the system, look for leakage, or traces of liquid and contact Service

17.5 Needle or Shearvalve Ooptosensor Failure is indicated

Follow shear valve maintenance procedure as discussed in chapter 15.4. If the error persist contact
service.

17.5.1.1 No Image on Display, No Backlight

 Contact your service engineer

17.5.1.2 Touch Sensitive Surface Not Working

 Connect an external USB mouse:
o This will allow clicking on the screen elements
o Contact service for resolution of the problem

17.5.1.3 Touch (Click) Is Inaccurate

 The touch screen needs calibration
 Connect an external USB mouse

17.5.1.4 The Cursor Seems To Be Moving With Good Ratios, But In a Smaller Area
 Calibrate the touch screen. (use an external USB mouse to access the function)
 If the problem persists, contact service

17.5.2 The Analyzer Does Not Power On

 Check proper power connections, and the state of the external 24V power supply. Do not replace
external power supply with a non-conform type.
 Contact Service

17.6 Fluctuating PLT background values

When the Aquila analyzer has a heavy workload, blood protein residue can accumulate in the fluidic
system despite the in built maintenance programs and the system may require intensive cleaning from
time to time. If you find that blank PLT values are increasing and decreasing unexpectedly, please perform
a ‘Hard cleaning’ maintenance function.

P a g e 161
18 Appendix
18.1 Device Specification summary
Feature Specification or description
H 369 mm 14 1/2 inches

Dimensions W 275 mm 10 3/4 inches

D 325 mm 12 3/4 inches

Weight, A1-1 (without reagent) 12,9 kg 28,7 lbs.

Weight, A1-2 (built-in battery, 29,9 lbs.
13,45 kg
without reagent)
Whole blood taken from sample vial: ~20 l
Sample volume
Processed volume through shear valve: ~6,5 l
Sample type Human whole blood (K3, K2 EDTA anticoagulant)
By means of the front panel keyboard (enter ID)
Tube Identification
By means of the barcode labels (external BCR)
Vertical piercing needle for sample aspiration
Sampling method
Sample cut by 4 position ceramic shear valve with 1 primary loop
WBC;RBC;HGB;MCV;HCT; MCH;MCHC;RDW-SD;PDW-SD
Measured parameters RDW-CV;PDW-CV;PLT;PCT;MPV;*P-LCC;*P-LCR
LYM, LYM%; MID, MID%; GRA, GRA% *research purposes only
Throughput 60 tests/hour
Cycle time
Normal mode: 60 sec
(for altitude < 1000m)

Runtime on fully charged Up time: min 4 hrs.

battery (A1-2 only) Continuous measurement: min 100 sample.

Parallel volumetric impedance change for WBC, RBC, PLT

Number of measure chambers and amplifiers: 2.
Measurement methods
Number of mix chambers: 1.
Spectrophotometry for HGB
Aperture diameter WBC: 80 m, RBC/PLT: 70 m
Aperture length WBC: 80 m, RBC/PLT: 70 m
Compensated light absorbance measurement.
HGB measurement Light source: green LED with 568 nm wavelength
Detector: light to frequency converter
Diatro 3P Reagent Smart Pack (DRP074)
Reagents
Diatro•Hypoclean CC (daily cleaner) – load manually
WBC dilution - 1:144
Dilution ratios (approx.)
RBC/PLT dilution - 1:24400
Control material Diacon3. Manufacturer: Diatron
Daily QC measure supported.
Quality Control
3 level (low, normal, high) QC diagrams, QC database
Parameter flag for blank measurements.
Parameter flags for human: over limit, panic level, warning
Flagging
Interpretative flags, based on parameters.
Lab limits (normal ranges) can be defined by user.

P a g e 162
Feature
Calibration
Languages available
Software upgrade
Database storage capacity
System full capacity
Computer
Operating system
Display
External printing
External keyboard
Bar-Code reader
Peripherals, ports
Power requirements
Built-in battery (A1-2 only)
Operating temperature
Maximum relative humidity
Shipment temperature
Storage temperature
Maximum relative humidity
during storage
Specification or description
Manual factor modification, or automatic measurement (3,5,7
times) with control or human material
Menu: English, German, Indonesian, Italian, Greek
Key map: US
Via USB storage device
10,000 records including flags and histograms. Backup and
export features are available.
32 GB, mSATA flash drive
Intel®Cel.N2807; dual core; @1,6GHz SMARC PC;2GB RAM
Windows® 8.1/10 Industrial Embedded 32bit
10”, @1280x800 pixel; TFT LCD, landscape layout, capacitive
touch sensor, gesture sensing activated
Via USB port, any commercial Windows 8.1/10 compatible inkjet
or laser printer.
Preloaded driver support for Zebra ZQ320 thermoprinter
Note: Log and Calibration History is not printed by thermoprinter
Standard USB PC keyboard, Qwerty map
External line or 2D barcode reader, connection via USB.
General USB SNAPI interface support from High Level software
Preloaded driver and support for Motorola DS4208/4308SR
6 x USB 2.0, 1x RJ45 Ethernet
Power supply input: 100-127VAC/200-240 VAC; 47Hz to 63Hz
Power Consumption: maximum 90 VA
System: Li Ion 8 cells; Capacity: 5,2Ah; Voltage: 14,8 V
15-30C (59-86°F)
80% non-condensing
5-40 °C (59-104°F)
5-35°C (41-95 °F)
80% non condensing
Table 17. Aquila Specifications
P a g e 163
18.2 Reagent Consumption
The unity reagent consumption of the Aquila hematology analyzer, group by fluidic operations:
DILUENT LYSE

MEASUREMENT 11,65 ml 0,28 ml

STANDBY 2 ml 0 ml

WAKEUP 0 ml 0 ml

STARTUP* 11 ml 3 ml

SHUTDOWN 7,9 ml 0,4 ml

CLEANING 5,9 ml 0,4 ml

HARD CLEANING** 3 ml 0 ml

REAGENT PACK VOLUMES 2333 ml 150 ml

* THE STARTUP CONSUMPTION CAN DEPEND ON THE INSTRUMENT STATUS

** HARD CLEANING HYPOCLEAN CC CONSUMPTION IS 0,11mL

Table 18. Reagent Consumption*

**The Hypoclean CC is an external reagent which must be inserted manually during hard cleaning.
For consumption beside different conditions, turn to manufacturer for calculation chart.

P a g e 164
18.3 Display Ranges of Parameters
Parameter Display Range Linearity Range Unit Selectable
Dimensions
WBC 0.0 – 120.0 0.0 – 100.0 * 103/µL or 109/l cells/µL, cells/l
LYM 0.0 – 100.0 0.0 – 100.0 * 103/µL or 109/l cells/µL, cells/l
MID 0.0 – 100.0 0.0 – 100.0 * 103/µL or 109/l cells/µL, cells/l
GRA 0.0 – 100.0 0.0 – 100.0 * 103/µL or 109/l cells/µL, cells/l
LYM% 0 -100 % Not selectable
MID% 0 -100 % Not selectable
GRA% 0 -100 % Not selectable
RBC 0.0 – 10.0 0.0 – 8.0 * 106/µL or 1012/l cells/µL, cells/l
HGB 0 – 30 1 – 25 g/dL g/dL, g/L, mmol/L
0 – 300 10 – 250 g/L
0-18.6 0.62-15.5 mmol/L
HCT 0 – 80 0 –60 % or abs percentage or
0 – 0.8 0 – 0.6 absolute
MCV 0 – 300 0 - 250 fl Not selectable
MCH 0 - 3000 1.25 -2500 pg or fmol depends on HGB unit
MCHC 0 - 3000 16.6 - 2500 g/dL or g/L or same as HGB unit
mmol/L
RDWsd 10 -300 10 -250 fl Not selectable
RDWcv 0 -100 0 -100 % Not selectable
PLT 0 – 2400 0-1000 * 103/µL or 109/l cells/µL, cells/l
PLCC 0 – 2400 * 103/µL or 109/l cells/µL, cells/l
PLCR 0-100 % Not selectable
PCT 0.0 -3.5 0.0 – 3.0 Not selectable
MPV 3.0 – 35.0 4.0 – 30.0 fl Not selectable
PDWsd 3.0 -70.0 3.0 – 60.0 fl Not selectable
PDWcv 0.0 -100.0 0.0 -100.0 % Not selectable
Table 19. Display Ranges of Parameters

P a g e 165
18.4 Performance Characteristics

18.4.1 Precision
Device repeatability and reproducibility are defined as a standard deviation (SD) or as a coefficient of
variation (CV), whichever is greater. Specifications are provided for primary and derived parameters
only.
Parameter Repeatability
SD CV%
3
WBC (10 /µL) < 0.18 < 2.7 %
GRA% (%) < 3.5 < 6.0%
LYM% (%) < 3.1 < 6.0%
MID% (%) < 2.0 < 12.0%
6
RBC (10 /µL) < 0.11 < 1.7 %
HGB (g/dL) < 0.20 < 2.0 %
MCV (fl) < 1.0 < 1.7 %
HCT (%) < 1.2 < 2.4 %
RDW (%) < 0.4 < 2.5 %
3
PLT (10 /µL) < 20 < 6.0 %
MPV (fl) < 0.45 < 8.7 %
PDW cv (%) < 0.5 < 2.0 %
Table 20. Precision Performance

18.4.2 Normal Mode Linearity

Linearity is defined for the primary measured parameters.
Parameter Nonlinearity Nonlinearity Reportable Reportable
absolute error relative error Low High
WBC (103/µL) < 0.80 < 3.0 % 9.86 102.4
HGB (g/dL) < 0.27 < 3.0 % 3.45 23.3
RBC (106/µL) < 0.20 < 3.0 % 1.29 8.15
PLT (103/µL) < 35 < 3.0 % 20 1000

Table 21. Normal Linearity Performance

P a g e 166
 18.4.3 Accuracy
Device accuracy is defined as a maximum predicted difference (bias) between this analyzer and an
alternate method. The difference must be less than the absolute or percent difference criteria in the table
below over an expected range. Specifications are provided for primary and derived parameters only.
Parameter Difference Criteria Evaluation Levels
Absolute Percent Range Low Range High
WBC (103/µL) 0.30 6.00% 0.00 100.00
GRA% (%) 3.00 10.00% 0.00 100.00
LYM% (%) 3.00 10.00% 0.00 100.00
MID% (%) 3.00 10.00% 0.00 40.00
RBC (106/µL) 0.15 6.00% 0.00 8.00
HGB (g/dL) 0.7 from 1 to 6 g/dl 6.00% 0.00 25.00
0.3 from 6 to 25 g/dl
MCV (fl) 1.00 6.00% 50.00 120.00
HCT(%) 3.00 6.00% 0.00 100.00
RDW (%) 0.50 6.00% 8.00 20.00
PLT (103/µL) 15.00 8.00% 0.00 1000.00
MPV (fl) 0.50 10.00% 5.00 30.00
Table 22. Accuracy Performance

18.4.4 Carryover
Based on clinical validation report in January, 2017.
Parameter WBC (103/µL) RBC (106/µL) HGB (g/dL) PLT (103/µL)
Criteria 1.00% 0.5% 0.8% 1.00%
Measured 0.16% 0.2% 0.0% 0.06%
Table 23. Carryover Performance

18.4.5 Background Limits In Normal Measurement Mode

Parameter Unit Blank high limit
WBC 3 0.2
10 cells/l
HGB g/dL 0.2
RBC 106 cells/l 0.05
PLT 103 cells/l 10
Table 24. Normal Background Limits

P a g e 167
18.5 Printed Measurement Report

P a g e 168
18.6 Tab Export File Internal Format
ID ##SampleID ##CREATE__DATE Profile ##TubeType ##User WBC RBC
PLT HGB MID GRA MID% ##GRAP HCT MCV MCH MCHC
##RDWSD ##RDWCV ##PDWSD ##PDWCV MPV PCT ##PLCR
##PLCC ##Probv__WBC ##Probv__RBC ##warning
6640 Stress_15 2016.09.13. 21:33:06 BLANK Vacutainer DefaultUser -0,12455
0,003114451 6,988946 0,1235253 0 0 0 0 0 0
0 0 0 0 0 0 0 0 0 0
11
6639 Stress_13 2016.09.13. 21:31:12 BLANK Vacutainer DefaultUser 9,830193
4,417321 238,6586 119,3198 1,099987 5,933149 11,18988
60,35639 23,58308 53,38773 27,0118 505,9552 34,86119
24,27793 15,82583 33,44446 7,617698 0,1818029 16,7005
39,85717 11
6638 Stress_11 2016.09.13. 21:00:11 BLANK Vacutainer DefaultUser 9,830193
4,417321 238,6586 119,3198 1,099987 5,933149 11,18988
60,35639 23,58308 53,38773 27,0118 505,9552 34,86119
24,27793 15,82583 33,44446 7,617698 0,1818029 16,7005
39,85717 11
5629 Sample_0129 2016.08.17. 9:07:00 HUMAN Vacutainer DefaultUser
0,04301218 0,0014015 5,816354 1,786279 0,01562746
0,02074851 36,33265 48,23868 0 0 0 0 0 0
0 0 0 0 0 0 7

In the above example, four measurement records are saved as Tab separated listfile. To test or use this
sample data follow this procedure: 1) Create a plain empty textfile, 2) copy the above content into, then
3) save it as <name>.txt. Content now is available for study or to insert into a spreadsheet application.

P a g e 169