Fairy Crux PR01 Collimator User Manual

Fairy Crux PR01 Collimator

Product Information

Specifications

• Mounting: Flange
• Flange fixed mode
• Control Mode: Manual control
• Maximum Radiation: 150kV
• Inherent Filtration: 1 mm Al Equivalent
• X-ray beam: 75 kV
• Rectangular X-ray Field Selection: Min – 2 x 2 cm, Max – 43 x 43 cm
• Set Focus Distance (SID=100cm)
• X-Ray Field Deviation: 1% of SID
• Light Field Indicator: 180 lux at 1 m from the focus, field size set at 35×35 cm

Product Usage Instructions

Device Description

• Intended Use
  The collimator is designed for use with mobile and stationary X-ray machines to control the X-ray field.

• Description of the Collimator
  The collimator is manual control, rectangular field, multi-leaf collimator. It can be adjusted using two knobs on the front panel to limit the X-ray field. LED light can be activated to indicate the X-ray diagnostic area.

• Symbols of Indications
  The symbols used indicate the functions of cross shutters, long shutters, and operating light fields.

How to Use

1. Install the collimator in the X-ray machine as per the manufacturer’s instructions.
2. Adjust the X-ray field size using the two knobs on the collimator’s front panel.
3. To activate the LED light indicating the diagnostic area, press the button on the front panel.
4. Ensure that the collimator is securely fixed in place before using it with the X-ray machine.

FAQ

• Q: Can the collimator support rotation?
  A: No, the flange of this collimator does not support rotation.

• Q: What is the maximum radiation level of the collimator?
  A: The maximum radiation level of the collimator is 150kV.

This document contains confidential and proprietary information of Fairy, any reproduction, disclosure, or use in whole or in part is strictly prohibited, except as may be specifically authorized by prior written agreement or permission of Fairy.

Device description

Intended use
The device is intended to be used in medical diagnostic applications. The device is intended to be used as an accessory of an X-ray system in a professional healthcare facility environment. The device is intended to restrict the dimensions of a diagnostic X-ray field by limiting the primary X-ray beam. The device is not intended to be used in fluoroscopy applications, near active HF Surgical Equipment or in the RF-shielded room of a system for magnetic resonance imaging, where the intensity of Electromagnetic Disturbances is high.

Description of the collimator
The collimator is manual control, rectangular field, multi-leaf collimator. It can be installed in the mobile and stationary X-ray machines The X-ray field is limited by 2 pairs of lead shutters and can be manually adjusted by two knobs on the front panel of the collimator. Around the knobs, there’re indications of scales in cm. The LED light is controlled by the button on the front panel. The flange of this collimator does not support rotation.

Symbols of indications
The following symbols are used to indicate the functions:

Symbol

| Definition|

Description

---|---|---
| Cross shutters| The bold lines indicate the shutter pair seen from the top side of the collimator
---|---|---
| Long shutters
| Operate light field| The LED light can be activated by pressing the button. It indicates the X-ray diagnostic area.

Specifications

Technical specification

Inherent Filtration Al. Equivalent X-ray beam = 75 kV

EN 60601-1-3 par. 7.3; 7.4

|

1 mm Al

Rectangular X-ray Field Selection Set Focus Distance, SID=100cm

EN 60601-2-54

|

Min: ≤2 x 2 cm Max: ≥43 x 43 cm

X-Ray Field Deviation| ≤1% of SID
Light Field Indicator

Luminosity at 1 m from the focus, field size set at 35×35 cm.

| ＞ 180 lux with White

LED power set to 85%

EN 60601-2-54|
---|---
Light Field Indicator – Contrast

Edge Contrast Setting 35×35 cm at 1 m SID EN 60601-2-54

|

4:1

Light Field Indicator Precision

Light Field/X-ray Field Correspondence EN 60601-2-54

|

≤ 1% of SID

Light source ON time| 30 s
Maximum Radiation Leakage

Measured at 100 cm with X-ray Beam = 150 kVp – 4 mA EN 60601-2-54

|

<1 mGy/h

Power Supply| 24V AC/DC, max. 4A
Dimension| 210mm239mm91mm
Weight| 6.5 kg ±0.5
Operation Environment

• Ambient Temperature
• Relative Humidity (no condensing)
• Atmospheric Pressure

|

10℃~40℃

30%~85%

700 mbar~1060 mbar

Storage

• Ambient Temperature
• Relative Humidity (no condensing)
• Atmospheric Pressure

|

-20℃~70℃ 10%~90%

500 mbar~1060 mbar

Overview of the collimator

Accessory rails

The accessory rails support to load of two accessories of 144 mm (width) ×1.8 mm (thickness).

Regulatory classifications

Electrical safety

classification

| Class I| IEC 60601-1
LED light| Risk Group 2| IEC 62471

Installation instructions

Mounting the collimator to the X-ray tube
CAREFULLY FOLLOW THE MOUNTING INSTRUCTIONS AND MAKE SURE THAT THE COLLIMATOR IS CORRECTLY ASSEMBLED. INCORRECT MOUNTING COULD BE DANGEROUS: IT COULD CAUSE THE COLLIMATOR TO FALL OR TO OPERATE INACCURATELY.

Mounting the Flange

• Use the X-ray tube housing literature to determine the distance from the focal spot to the tube port face.
• Make sure that the flange is supplied with a collimator.
• Mount the flange and spacers to the tube port with 4 screws that must be long enough to be driven into the tube port face for at least 5 threads.
• Tighten the screws.

IMPORTANT
TO SAFEGUARD THE OPERATOR AND PATIENT AGAINST THE HAZARD OF A FALLING COLLIMATOR, THE FOLLOWING INDICATIONS MUST BE RESPECTED.

Mounting the Collimator to the Flange

• Unscrew the four mounting Allen screws until the four tabs are withdrawn from the collimator top opening, see Figure 6.1.1 and Figure 6.1.2 in this Chapter.
  • WHEN UNSCREWING THE ALLEN SCREWS WHICH CONTROL THE TABS, DO NOT USE FORCE EXCEEDING 0,55 NM.
  • UNSCREW WITH CARE SO AS NOT TO DAMAGE THE FIXING TABS.

Electrical interface
The electrical interface is composed of 3 MPD1.25-156 bullet male terminals, of which the yellow and green wires are the ground wires and the other two wires are the power wires.

Spare parts

Repairs

In the event the customer finds any noncompliance or malfunctions of the collimator, contact Fairy via e-mail at the address: 0573@fairyelectrics.com.

The information must include:

• The model and serial number of the collimator are found on the label.
• A detailed description of the problem (in Chinese or English).
• It is important to specify if you want a repair or a total refurbishment of the product.

Fairy will resolve the problem by either providing directions and/or field service or by sending replacement parts.
In the event the collimator needs to be repaired at Fairy, customer service will immediately provide the customer with an RMA (Return Merchandise Authorization) number as your consent to the return and provide all necessary additional information.
The shipping of the unit is at the customer’s expense if the unit is out of warranty, see paragraph WARRANTY in this chapter.
Fairy reserves the right to decide if the collimator is to be repaired or substituted.
Defective material is to be sent to:

Fairy Medical Electrics (Jiaxing)Co., Ltd.

• Floor 4, Building 3, No.199, Ya’ao RD., Daqiao Town, Nanhu District, Jiaxing City, Zhejiang Province, China.
• EMAIL: 0573@fairyelectrics.com.

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