Huvitz HFC-1 User manual

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
REV R-3 PAGE 1 / 36
Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
[Summary]
Applied Standard MDR 2017/745
△
2MDD 93/42/EEC
Product Name Fundus camera
Model/Type
H
FC
-
1
(with Webviewer software)
Manufacture Name Huvitz Co.,Ltd.
Manufacture’s
Address
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si
Gyeonggi-Do, 14055, Republic of Korea
Homepage: www.huvitz.com
Trade Mark Huvitz
Comment
Prepared By R&D Project Leader Sang Jeon,
Park 2020.06.08
Reviewed By Q.M Manager Hyung Min, Heo 2020.06.08
Approved By Q.M Leader Lee Chang-Soo 2020.06.08
Date of issue 2020.06.08.

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
■ REVISION HISTORY
NO DATE REVISED REASON REVISED CONTENT
0 2019-07-19 First issued All
1 2020-02-13 Periodic Review Added UDI-DI number in clause 1.5)
2 2020-05-15 Periodic Review Added Medical Device Directive
93/42/EEC in applied standard
3 2020-06-08 Periodic Review
Added stereo analysis description in
clause 4 due to added stereo function.
Changed UI image of analysis setting in
clause 4 due to added stereo function.
4
5
6
7
8
9

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
1. General Description
1) Indication for use:
The Huvitz Fundus camera HFC-1 is a non-contact, bio-microscopic imaging device. It is indicated for
in-vivo viewing, color fundus imaging.
2) Intended Use
A device that illuminates the fundus by entering light into the pupil and photographs the fundus state
according to the reflected light.
Figure 1. Fundus camera HFC-1
3) User profile
The equipment must be operated only by a, or under direct supervision of properly trained and
qualified person/s such as ophthalmologist.
a. Age: adult (> 21 years of age)
b. Occupation: Optometrist, ophthalmologist
c. Level of training: Recommend completing training how to use it is.
d. Education: Basic training is required for the use of equipment. (Obtains a certificate of qualification
such as optics, medical school, etc., after completing a certain amount of education.)
4) Patient Profile
The patient who undergoes and examination by this instrument must maintain concentration for a few minutes
and adhere to the following instructions;
- After his/her face to the chinrest, headrest.
- Keep the eye open
- Understand and follow instructions when undergoing an examination.
If the patient does not conform to these conditions, it is not possible to take a picture correctly
a. Age: not relevant
b. Weight / Height: not relevant
c. Health: not relevant
d. Nationality: multiple
e. Patient state: not relevant
- HFC-1 should be used for all patients who need eye-examination in compliance with the
contraindications.

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
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HFC-1
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C
ontraindications
This device should not be used for:
•Patients who are hypersensitive to light.
•Patients who recently underwent photodynamic therapy
•Patients taking medication that causes photosensitivity
△
15) UDI Information
Basic UDI-DI: 08800019600541
2. Dimension and weight
-. Dimension: 330(W) x 542(D) x 521(H) mm
-. Weight: 28kg
3. Photo View
(1) External Picture
Front Rear

Product Description DOCUMENT HQI-J-FC1-001
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HFC-1
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
Left Right
Bottom

Product Description DOCUMENT HQI-J-FC1-001
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HFC-1
RE_DATE 2020-06-08
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(2) External Description
1) Front View
No Part Name Description
1 Display LCD Monitor for displaying captured image and user interface icon.
2
Body
Chinrest button Button for moving chinrest up and down.
3 Joystick Joystick for aligning body to patient’s eye.
Button for capturing image.
4 User Lock Lock for fixing body to base frame.
5 OPT button Button for optimizing signal
6-1
6-2 Align index mark Mark for indicating center of body and base.
7
Base
Power button Button for turning power of internal PC on/off.
When the power is on, white light is lit.
9-1 Power switch Switch for power on/off.
9-2 Power inlet Inlet for connecting power cable.
10 Headrest Eye level mark Mark for indicating base height of patient’s eye.
11 Body Heat vent Window for emitting internal heat.
①
④
③⑤
⑥-1
⑨
②
⑥-2
⑦
⑨-1 ⑨-2
⑩
⑪

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
2) Rearview
No Part Name Description
1
Headrest
Forehead rest Rubber for fix patient’s head.
2 External LED External LED for fixing patient’s eyes.
3 Chinrest For fixing patient’s chin.
4-1
Body
Objective lens Lens for passing illumination light from body and reflected
light from patient’s eye.
4-2 Mirering Focus LED LEDs for checking working distance.
5 Headrest Objective lens cap Cap for protecting objective lens.
8
Base
External port Port for communicating internal or external device.
8-1 RS-232 port Port for communicating internal PC board and main board.
⑧-4
①
③
②
④-1
⑤
④-2
⑧
⑧-3
⑧-1
⑧-2
⑧-5

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
8-2 RGB port Port for external display device.
8-3 DP port Port for communicating external DP device.
8-4 LAN port Port for external network (2 ports)
8-5 USB port Port for internal or external USB device (4 ports)
3) Bottom View
No Part Name Description
1 Base Packing lock Lock for fixing body and base during transportation. (2 points)
①

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
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HFC-1
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4. GUI Interface
1) Observation screen
No Name Function
1 Patient information Shows the information of patient ID and name. Go back to patient list by clicking
the icon.
2 Observation mode Show current observation mode.
Capture Fundus image.
3 OD/OS
Show current eye position.
- OD: right eye
- OS: left eye
4 AUTO S Show auto shooting selection status.
5 AUTO T Show auto tracking selection status.
6 FIXATION Select position of internal fixation target.
7 C LENS
Show compensation lens status.
0: No compensation lens is used.
-: Minus compensation lens is used.
+: Plus compensation lens is used.
8 IR-ILL Select brightness level of IR light for fundus observation.
Normal / Bright mode is toggled by clicking.
9 S.Pupil Show small pupil mode selection status for fundus image.
10 FIXATION BR Control Fixation brightness.
11 Capture mode
Select capture mode.
- Single Macular: Capture one fundus image for Macular.
- Single Disc: Capture one fundus image for Optic Disc.
△
3- Stereo Macular: Capture 2 fundus images for Macular stereo analysis.
❻
❽
⓫
❶❷❸
❺
❼
⓬
❿
❹
❾
⓭
⓮
⓯

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
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△
3- Stereo Disc: Capture 2 fundus images for Disc stereo analysis.
- Widefield Panorama: Capture maximum 7 images and stitch it.
12 Focus Move in accordance with focus of patient’s eye.
13 IR.En Change brightness of IR fundus image
14 Flash Change brightness level of white light for capturing fundus image.
15 Optimize Find focus position automatically by split focus image.
2) Confirmation screen
No Name Function
1 Image selection
Decide validity of current image.
- OK: Save current image.
- RETRY: Discard current image and retry capturing.
2 Analyze Save the camera DATA and enter the analysis screen
3Fundus
information Display setting information of fundus image.
4 Fundus image Show captured fundus image.
❷
❶
❸
❹

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
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3) SETUP Menu
[To choose the section to setup]
- Setup mode consists of seven sections: System, Patient, Measure, Analysis, Report and info. You
can select the section to setup from the left side.
- You can navigate the setup items with the page move buttons [ , ] or the page numbers [ ,
] at the bottom.
[To change settings]
- Select the item to change.
- To press OK button [ ] will save all the changes made and exit the setup screen.
- To press CANCEL button [ ] will discard the changes and exit the setup screen.
-. System Settings
Device Name Set Device Name.
Server IP Web Viewer Server IP address setting.
Sever Port Web Viewer Server port setting.
Sleep Time Sleep mode setting.
Auto Data Trans Set the function to transfer the measured data to
Web Viewer automatically.

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
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HFC-1
RE_DATE 2020-06-08
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Touch Keyboard Touch Keyboard ON/OFF setting.
Objective Lens Clean
When this option is turned on, the Light is turned
on for convenient cleaning of the Objective
Lens.
User Set User ID and Password for Login.
Auto Export Auto export setting
Langu
a
ge
L
anguage
setting
.
-. Patient Settings
Patient List Size Number of patients to be displayed per pages.
Today List Today List (List of patients visited today)
settings.
PID Prefix The function to set the prefix of the patient ID.
PID Postfix The function to set the postfix of the patient ID.
PID Number Length The function to set the length of patient ID.
Date Format Format of the date (Year, Month, Day).
Staff Management Register staffs
Auto Import Auto import setting

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
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HFC-1
RE_DATE 2020-06-08
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
Auto Import Path Assign the import path
Auto Import Interval Set the interval of auto import
-. Measure Settings.
Auto Tracking Auto Tracking ON/OFF setting.
Auto Shoot Auto Shoot ON/OFF setting.
Fundus Preset Set fundus Preset.
Small Pupil Guide Small Pupil Guide ON/OFF setting.
Pupil Size Text Pupil Size Text ON/OFF setting.
Fundus Compression Set the Fundus image compression ratio.
Show Fixation Position Show Fixation Position ON/OFF setting.
Show Aiming Dot Show Aiming Dot ON/OFF setting.

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
-. △
3Analysis Settings
Fundus B/C Adjust
Apply the standard values of brightness and
contrast to the measured fundus image
automatically.
Fundus Color Adjust Apply the standard values of UB and VR to the
measured fundus image automatically.
Fundus Edge Sharpen Apply edge sharpening function to the measured
fundus image automatically.
Fundus Enhancement Set the enhancement level of Fundus image
T
ext Color
Set the measurement value text(ruler value) color.
-. Report Settings
Report Logo
Set the report logo image.
Report Brightness Set the report print brightness.
Report Type Set the orientation of report print.
Pupil Size Set the pupil size information.
Organization Assign the organization.
Fundus Report Type Decide the type of fundus image.

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
5. Accessories
①Chinrest paper ②Touch pen ③Power cable ④Fuse ⑤Dust cover
⑥External LED ⑦Blower ⑧User manual ⑨Packing lock cap ⑩Model Eye
No. Accessory name Function Specification Quantity
1Chinrest paper Spare parts Material: paper, Finish: natural
Size: 130 x 40 x 0.05mm, 1 unit
2Touch pen LCD Touch pen ф11 x 128mm, ф4.8 x 95mm 1 unit
3Power cable Connect the device to power
line
(Detachable) Rated 10 A, 250V.
Plug type CEE7, Connector type
IEC 60320/C13, and Cord type
H05VV-F3G, min. 0.75 mm2, 3-
conductor terminating in molded-
on grounding type attachment
plug. <HAR> marked on the cord.
Maximum 2.5 m long.
1 unit
4Fuse Spare parts 250V, T 3.15AL 2 units
5Dust cover Covering the device when is
unused
Size: 340*560*530mm
Material: Hanibon PD3085LAIN 1 unit
6External LED External LED for fixing
patient’s eyes.
ф17 x 392mm 1 unit
7Blower removing dust on the surface
of lens
ф55 x 153mm 1 unit
8User manual Instruction for use A4 1 volume
9Packing lock cap a cap that unlocks and covers
the hall
ф17.0 x 4.6mm 1 unit
10 Model Eye Self-diagnosis using Model
eye
108 x 33 x 103mm 1 unit

Product Description DOCUMENT HQI-J-FC1-001
ES_DATE 2019-07-19
Fundus camera
HFC-1
RE_DATE 2020-06-08
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6. Specification
6.1 Device Specification
Device specifications
Type Non-mydriatic fundus camera
Resolution
Center
:60 lines/mm or more
Middle(r/2) :40 lines/mm or more
Periphery(r) :25 lines/mm or more
Angle of view 45˚
Camera Color Image Sensor
Minimum pupil diameter 4.0 mm (Normal mode), 3.3 mm (Small pupil mode)
Flash light White light
Working distance 33 mm
Display 12.1 inch, 1280x800 pixel, Touch panel color LCD
Dioptric compensation for
patient’s eye
-
33D ~ +33D total
-33D ~ -7D with minus compensation lens
-13D ~ +13D with no compensation lens
+7D ~ +33D with plus compensation lens
Fixation target LCD (internal), White LED (external)
Horizontal movement 70 mm (back and forth), 100 mm (left and right)
Vertical movement 30 mm
Chinrest movement 62 mm (up and down), motorized
Auto tracking X,Y for positioning, Z for working distance
Power supply AC 100 - 240 V, 50/60 Hz, 1.6 - 0.7 A
PC Built in computer
Dimensions 330(W) x 542(D) x 521(H) mm
Mass 28 kg
6.2 Essential Performance
Essential
Performance
Associated
unacceptable risk Failure Mode Risk Control
1. The imaging of
the fundus should
be good
1. Incorrect output
of intraocular
image
1. Intraocular
image is distorted
due to degradation
of resolution
1. An algorithm that satisfies the
following error rates is required
A. Center: more than 60 line pairs /
mm
B. Medium: more than 40 line pairs
/ mm
C. Around: more than 25 line pairs /
mm
1. 안저 이미지의
촬영이 잘 되어질
것
1. 잘못된 안구
이미지 출력
1. 해상력 저하로
인한 이미지가
왜곡되어짐
1. 아래의 오차율을 만족할 수
있는 알고리즘 필요
a. 중심: 60 line pairs/mm 이상
b. 중간: 40 line pairs/mm 이상
c. 주변: 25 line pairs/mm 이상

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ES_DATE 2019-07-19
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HFC-1
RE_DATE 2020-06-08
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7. Functional Description
7.1 Block Diagram
7.2 Part’s Function
No. General
Name and
critical
feature
part(*)
Function Drawing Part name Part Code /
Revision No.
1 INLET(*) Input power: 100-240vac
50/60Hz
AC INLET FILTER(CIT-
FUSE,0215005.MXP)
79050010004
2 Power
switch(*)
Turn on or Turn off the
device
SWITCH(ON-OFF) 76010010002
3 FUSE(*) 50T, 250V, 3.15A rated fuse Fuse 7610S005031
4 SMPS(*) Convert the AC power to DC
output
SMPS(DELTA 400W) 75010010008-A
5 Main control
B/D(*)
Signal processing
Control of LED and Sensor,
Motor
PCB ASSY(MAIN-111) W2EPCB0001-
AB
6 Auto
alignment
interface
B/D
XYZ stage motor driver B/D PCB ASSY(AAM-200) W2EPCB0010-
AA
7 Joystick
ASSY
Joystick for moving head
optics and capturing images
by pressing capture button.
A8-JOYSTICK-ASSY A8MASSY005-
AD
8 Base
interface
B/D
DC power distribution and
control signal router.
PCB ASSY(BASE IF-
110)
W2EPCB0016-
AB
9 Head Rest
ASSY
chinrest for patients W2_HR-HEAD-REST-
ASSY
W2MASSY006-
AA
10 Embedded
PC B/D
computer unit for GUIs and
control
PC MOTHER BOARD 79990010022-A

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ES_DATE 2019-07-19
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HFC-1
RE_DATE 2020-06-08
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Q-I-300-02(R1):2018/06/04 Huvitz Co.,Ltd
11 Color
fundus
camera(*)
Camera for capturing color
fundus image
CAMERA(BFS-U3-
200S6C-C)
72030010002-A
12 White LED illumination source for color
fundus imaging
LED(VERO 29) 71010030002-A
13 Mire-ring
LED
working distance
measurement
IR LED(940NM) 71010040006-A
14 Cornea
Camera
camera for working distance
measurement and cornea
preview
PCB ASSY(CMOS
AR0130)
M2EPCB0007-
AA
15 Retina
Camera
camera for preview fundus
image
PCB ASSY(CMOS
AR0130)
M2EPCB0007-
AA
16 NIR LED illumination source for
cornea and retina camera
IR LED(740NM) 71010040005-A
17 XYZ motor XYZ stage motor for patient
alignment
수)DC MOTOR
Step motor(Y-Axis)
6430TMT3021-
A
64010010015
18 Touch LCD Display GUI(graphic user
interface)
LCD(GRAPHIC) 72050010012-A
7.3 Functional description and critical feature(*)
1) when turn on the device with power switch, SMPS convert the ac power to dc power. SMPS
supply the DC power to Mainboard, PC Board and electrical parts (LED, Sensor, Camera,
Scanner, Motor, LCD, Frame Grabber) through the Main B/D and the PC board. the fixation led
illuminate fixation target.
Main B/D perform a self-test to load the system configuration data. If there is an error, display the
error message (*)
and leave the message into log file, otherwise wait for entering ID/PWD on the LCD Touch screen.
2) When operator register a new patient, HFC save it into its Database.
3) When operator select the measurement mode, auto tracking mode on the LCD Touch screen,
HFC try to find the center of pupil and the exact focus distance. Operator needs to move the body
to be seen 6 mier LEDs and two focus LEDs, and then its auto-tracking is working properly. Auto-
tracking algorithm uses 6 mier LEDs, 2 focus LEDs, three X-Y-Z motors, and the anterior live
image.
4) When chinrest up/down icon is pushed, main b/d move the chinrest up/down motor in the
headrest ass’y.
5) Patient see the fixation led with a green colored cross marker.
6) In Fundus measurement, Press the joystick flashes LED array, and color camera gets an image
and HFC shows a color fundus image.

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ES_DATE 2019-07-19
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HFC-1
RE_DATE 2020-06-08
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7.4 Insulation Diagram
Area Number
and type
of Means
of
Protection:
MOOP,
MOPP
CTI Working
Voltage
Required
creepage
(mm)
Required
clearance
(mm)
Designed
creepage
(mm)
Designed
clearance
(mm)
Test point
Vrms Vpk
A 1 MOOP IIIb 240 339 2.4 2 4.7 4.7
Between Live
and Neutral
(before fuses)
B 1 MOOP IIIb 240 339 2.4 2 4.4 4.4
Between
primary circuit
and earthed
enclosure
C 2 MOOP IIIb 265 584 5.42 4.6 8.5 8.5
Between
SMPS primary
and
secondary
D 2 MOOP IIIb 240 339 4.8 4 12 12
Between
primary circuit
and
unearthed
enclosure
E 2 MOPP IIIb 265 584 8.4 7 8.5 8.5
Between
primary circuit
and Head
Rest/ChinRest
F 2 MOPP IIIb 12 3.4 1.6 12 12
Between
secondary
circuit and
Head
Rest/Chin
Rest

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G 2 MOOP IIIb 12 2 2 12 12
Between
secondary
circuit and un-
earthed
enclosure
1) The record was that obtained as the result of tests of certified SMPS (Report Ref. No. E356265-A11-
CB-
2) linear interpolation used
8. Operation Principle
The anterior of an eye is illuminated by IR light, the retina of an eye is illuminated by an infrared light
and a white LED, of which lightings are emitted by the fundus illumination optical system. The fundus
observation/photography optical system forms and makes an image with image sensors, which
images are observed and manipulated with the display panel.
8.1 Operator’s work flow
Flow Description and Critical Features(*)
1. Turn on the device
2. Prepare the patient
0. Select a patient or register a new patient.
1. Let the patient sit on the chair
2. Let the patient’s chin and forehead contact with
chinrest paper and headrest rubber.
3. Adjust the height of the chinrest by the chinrest
up/down icon until the patient’s eyes aligns with the Height
Adjustment Mark on the headrest assy.(*)
3. select Measurement Mode
Select the measurement mode, Auto tracking mode.
4. Optimize
Move the device body with joystick, and then press
‘Optimize’ Button to make a signal best.
5. MEASURE
Push the measurement button on the joystick.
6. Analysis & report
0. Analyze the exam of the patient.
1. Print or send out the Report.
7. Turn Off the device
1. Turn On the device
3. Select Mode
5. MEASURE
7. Turn Off the device
6. Analysis & Report
4. ALINGMENT & Optimize
2. Prepare the patient