User Manual for the Focus HD 43 Detector Publication No.
All rights reserved. No part of this manual may be reproduced or copied in any form by any means—graphic, electronic, or mechanical, including photocopying, typing, or information retrieval systems—without written permission.
Notices and Conventions The information herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health, Inc. prior to publication. No patent license is granted by this information. Carestream Health reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information.
Notices and Conventions Disclaimer • • • • • Carestream shall not be liable to the purchaser of this product or third parties for any damage, loss, or injury incurred by the purchaser or third parties as a result of fire, earthquake, any accident, misuse, or abuse of the product.
Contents Notices and Conventions Disclaimer......................................................................................................................................... -iv 1 Safety and Regulatory Information Medical Equipment Classification.................................................................................................. 1-1 Standards.........................................................................................................................................
1 Safety and Regulatory Information Medical Equipment Classification Type of protection against electrical shock Internal electrical power source equipment (battery) Degree of protection against electrical shock Type-B applied part Degree of protection against ingress of water IP56 Mode of operation Continuous operation Flammable anesthetics Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Not suitable for use in an oxygen-rich enviro
Safety and Regulatory Information Standards IEC 60601-1:2005/AMD1:2012 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014/EN60601-1-2:2015 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances v Requirements and tests IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes — Safety require
Safety and Regulatory Information Emissions and Immunity Compliance to the IEC60601-1-2 Standard Electromagnetic Emissions Emissions Test RF emissions Compliance CISPR 11 Group 1, Class B Harmonic distortion IEC 61000-3-2 Class A Voltage fluctuations and flicker IEC 61000-3-3 Compliance Electromagnetic Environment The Focus HD 43 Detector uses RF energy only for its internal function.
Safety and Regulatory Information Proximity Fields From RF Wireless Communications Equipment Test Levels Test Frequency (MHz) Band (MHz) 385 380–390 Pulse modulation 18 Hz, 27 V/m 450 430–470 FM, ±5 kHz deviation, 1 kHz sine, 28 V/m 704–787 Pulse modulation 217 Hz, 9 V/m 800-–960 Pulse modulation 18 Hz, 28 V/m 1700–1990 Pulse modulation 217 Hz, 28 V/m 2400–2570 Pulse modulation 217 Hz, 28 V/m 5100–5800 Pulse modulation 217 Hz, 9 V/m Professional healthcare facility environment 710 745 7
Safety and Regulatory Information Input AC Power Port Test Levels Emissions Test EMC Standard Professional healthcare facility environment Electrical fast transients/burst IEC 61000-4-4 ±2 kV 100 kHz repetition frequency Surges IEC 61000-4-5 ±0.5 kV, ±1 kV IEC 61000-4-5 ±0.5 kV, ±1kV, ±2 kV IEC 61000-4-6 3 V, 0.15 MHz–80 MHz Line-to-line Surges Line-to-ground Conducted disturbances induced by RF fields 6 V in ISM bands between 0.
Safety and Regulatory Information Signal Input/Output Parts Port Test Levels Emissions Test EMC Standard Professional healthcare facility environment Electrostatic Discharge IEC 61000-4-2 ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air Electrical fast transients/burst IEC 61000-4-4 ±1 kV 100 kHz repetition frequency Conducted disturbances induced by RF fields IEC 61000-4-6 3 V, 0.15 MHz–80 MHz 6 V in ISM bands between 0.
Safety and Regulatory Information CAUTION: Portable and RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in.) to any part of the Focus HD 43, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Focus HD 43 conforms to this IEC60601-1-2:2014/EN60601-1-2:2015 standard for both immunity and emissions.
Safety and Regulatory Information Radio Frequency Compliance Country Item FCC CFR47 Part 15C (2019) Radio Frequency Devices ANSI C63.10 (2013) FCC Code CFR47 Part15B (2020) U.S.A ANSI C63.4 (2014) FCC CFR47 Part 15E (2019) IEEE 1528- 2013 IEEE C95.1: 1991 IEEE C95.1: 1992 ETSI EN300 328 V2.2.2 ETSI EN301 893 V2.1.1 ETSI EN300 440 V2.1.1 ETSI EN 301 489-1 V2.2.3 ETSI EN 301 489-17 V3.2.4 European Union ETSI EN 301 489-3 V2.1.
Safety and Regulatory Information interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • • • • • Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver.
Safety and Regulatory Information cm between the radiator and your body. This device and its antenna(s) must not be colocated or operating in conjunction with any other antenna or transmitter. Correction and Calibration Template Generation Correction and calibration should be performed after installation and every six months. The new correction and calibration should be performed after any major change on the system settings and hardware configuration.
Safety and Regulatory Information Intended Use Intended Use These devices are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications.
Safety and Regulatory Information Additional guidance and recommendation are provided by the Alliance for Radiation Safety in Pediatric Imaging (Image Gently Alliance) https://www.imagegently.org/ Table 1: Techniques for Typical Body Parts Body Parts Abdomen AP/PA AL4609 Patient Size kVp mAs SID Grid Very Low Birth Weight (Less than 1.5 Kg) 55 1 1m no Low Birth Weight (Between 1.5 and 2.5 Kg) 55 1.6 1m no Newborn (Age is less than 1 month and Weight above than 2.5 Kg) 70 1.
Safety and Regulatory Information Body Parts Patient Size kVp mAs SID Grid Very Low Birth Weight 50 1 1m no Low Birth Weight 55 1 1m no Newborn 65 1 1m no Infant 70 1.6 1m no Child 70 1.6 1m no Preadolescent 90 2 1m yes Adolescent 90 2 1m yes Adult Small 110 1.8 1.8m yes Adult Medium 110 2.8 1.8m yes Adult Large 120 4 1.8m yes Very Low Birth Weight 50 1 1m no Low Birth Weight 55 1 1m no Newborn 57 1 1m no Infant 57 1.
Safety and Regulatory Information Adult Extremities List kVp mAs SID Grid Femur - AP 70 16 1 yes Femur - Lateral 70 10 1 yes Hand - PA 53 1.8 1 no Hand - oblique 53 1.8 1 no Humerus - AP 75 7.1 1 yes Humerus - Lateral 70 3.2 1 yes Knee - AP 65 10 1 yes Knee - Lateral 65 10 1 yes Wrist - PA 55 1.8 1 no Wrist - Lateral 55 1.
2 Operation Notes for Using Do the following to ensure that the detector functions correctly. Before Exposure Inspect the detector daily and confirm it is working properly. Check that there is no condensation on the any of the surfaces of the detector. Condensation can be caused by the sudden heating of the room in cold areas. If this occurs, wait until the condensation evaporates before performing an exposure or problems may occur with the quality of captured images.
Operation Cleaning and Disinfection of Patient Contact Surfaces After every examination, wipe the patient contact surfaces of the detector using disinfectants such as ethanol, to prevent the risk of infection. For details on how to sterilize, consult a specialist. CAUTION: Do not spray disinfectants or detergents directly onto the detector. To prevent damage to the surface of the detector, wipe with a cloth slightly dampened with a neutral detergent.
Operation This indicates operational temperature limits. This indicates storage temperature limits. This indicates FCC compliance. Package symbol: Fragile Package symbol: Keep away from sunlight. Package symbol: Keep dry. This indicates the humidity limits. Keep the product upright. Do not roll the transportation packaging.
Operation This indicates the stacking limit number. Rx only IP56 Device is for prescription use only. Degree of protection against water (IEC 60529). Type B Applied Part (IEC 60601). This indicates consulting the user guide for general information. Medical Device: Any serious incident that may occur in relation to this device should be reported to the manufacturer and the national competent authority.
Operation Cautions Environment for Installation and Use CAUTION: • • • • • • • • • • • Follow all safety labels on the equipment. For continued safe use of this equipment, follow the instructions contained in this operator's manual. Study this manual carefully before using the equipment and keep it at hand for quick reference. The equipment must be used only by qualified personnel and only after training in the specific operations.
Operation CAUTION: Non-medical equipment such as battery charger, access point and PoE device cannot be used in the vicinity of a patient. Power Supply CAUTION: Do not place heavy object on cables and cords. Do not pull, bend, bundle, or step on them to prevent damage to the sheath. Do not alter them. Avoid damage to the cords. CAUTION: Securely insert the power cord into the AC outlet to avoid a contact failure. CAUTION: • • Always connect a three-core power cord plug to a grounded AC power outlet.
Operation CAUTION: Do not place excessive weight on the panel to avoid damage to the internal image sensor and an incorrect image. Load Limit Uniform load: 300 kg over the whole area of the surface Local load: 100 kg on an area 4 cm diameter CAUTION: Be sure to use the product on a flat surface to prevent the product from bending and doing damage to the internal image sensor.
Operation CAUTION: • • • • • • • Do not invert the positive and negative poles. Do not submerge the battery in water. When in use, do not allow the battery to have contact with water. Store the battery in a dry place. Only use the charger provided to charge the battery. Do not replace the battery provided with one from another company. Only qualified personnel may replace the battery inside the main unit. Do not remove the battery when the detector is powered on.
Operation Detector Position To prevent abnormal light lines, place the detector behind the patient in the orientation shown below.
Operation Panel Installation Install the Detector Battery The detector can be powered by the battery package or DC power. The detector will be activated as soon as power is supplied and will power off as soon as power is removed. 1. Make sure that the connectors for the battery and battery compartment are aligned. 2. Slide the battery into the battery compartment. Note: Make sure the battery level is more than 15 % of full capacity. 3. Slide the battery lock lever toward the center of the detector.
Operation Power on the Detector On the control panel, the power button is used to power the detector on and off. To power on the detector, press and hold the power button for 2 seconds. The detector must either have a battery installed with > 15 % charge or have the DC power connected. To power off the detector, press and hold the power button for 4 seconds.
Operation Status Power Indicator Lighting Status Battery Capacity DC Input Description Green Blinking ≥ 95 % Yes Detector is OFF Green and Orange Blinking < 95 % Yes Detector is OFF Link Indicator Power Indicator Off Lighting Status Description • • Power OFF Wired connection broken and wireless connection not ready Wired connection is built (Service mode) Green On Blue On Blue Blinking AL4609 • • Client mode, wireless connection is built AP mode, wireless AP is ready (Not used) Clie
Operation Status Indicator Power Indicator Lighting Status Description Off Detector is OFF Green ON Exposure is allowed Green Blinking Detector is in WIFI mode switch status Orange On Error Mode Indicator Power Indicator Blue On Lighting Status Description Client mode is enabled 1. Press and hold the Mode button for approximately seven seconds. When the status LED indicator starts to blink, release the button.
Operation Power Indicator Lighting Status Description 1. Press and hold the Mode button for approximately seven seconds. When the status LED indicator starts to blink, release the button. Green Blinking The Mode LED indicator blinks green indicating that the detector is in AP mode. 2. Press and release the Mode button. The Mode LED indicator will blink from green to blue, indicating that WIFI mode has switched from AP to Client. 3.
Operation Install the Detector Battery Charger 1. Remove the battery from the battery charger. 2. Insert battery into battery charger in the orientation shown below. 3. Press the battery down into the battery compartment.
Operation Detector Battery Activation To ensure the safety of the battery during transportation or storage, the battery is set to ship mode where it is locked and will not provide any voltage output. Exit Ship Mode Method Steps Charger AL4609 1. Power on the charger. 2. Insert the battery into the charger for 3 to 5 seconds to exit ship mode.
3 Overview The Focus HD 43 is a cassette-size, wireless, digital, X-ray flat panel detector based on amorphous silicon thin-film transistor technologies. It is developed to provide the good quality of radiographic image, which contains an active matrix of 4267 × 4267 with 100 μm pixel pitch. The scintillator of Focus HD 43 is CsI (Caesium Iodide) which is direct deposit. Scope This manual contains information about the Focus HD 43.
Overview Components and Specifications Product Components Component Description Detector Item AL4609 Description Notes 1 DC input interface 2 Mode button 3 Detector status indicator 4 Mode indicator 5 Link indicator 6 Power level indicator 7 Power button 3-2 2021-09-21
Overview Battery Item Description A Battery label B Battery interface C Guide block D Touch display Battery Charger Item AL4609 Description Notes A Battery Interface A 8 pin battery connector for Focus 43C B Battery Interface B 7 pin battery connector for Focus HD 43 3-3 2021-09-21
Overview Item Description Notes C Battery Interface C Not used D Indicator The indicator definition is as follow E The limit ball plug / F Hand Pull Position / G AC Jack 220 V (ac) input Battery Charger Indicator Item Name A Power Indicator B Charging Indicator C Charge Full Indicator X Indicator Operating Status All off No power input A indicator on • • A indicator on Battery insertion self test AC power input Multiple batteries inserted B and C alternately blink 2 time
Overview X Indicator Operating Status A and C indicator on Battery capacity full, charging stops A indicator on Battery is not charging properly B and C alternately blinking Two or more batteries charging cannot be charged at the same time. Charging will automatically stop if more than one battery is inserted.
Overview Item Specifications Image Transfer WiFi Wireless : IEEE802.11 a/b/g/n/ac Power Consumption Max. 42 W Dimension (L × W × H) 460.0 x 460.0 x 15.0 mm (18.1 x 18.1 x 0.6 in.) Weight (with one battery) 3.5 kg (7.7 lb) Panel Protection IP56 Trigger Mode Software/AED Battery Item AL4609 Specifications Model Battery-KX Rated capacity Min. 4700mAh, Typ. 4900mAh @ Discharge 0.2C Nominal voltage 11.55 V Charge voltage 13.
Overview Item Specifications Charging method CC-CV Operating temperature Charge 0–60 °C (32–140 °F) Discharge -10–60 °C (14–140 °F) Storage temperature 1 month -20 °- +50 ° (-4–122 °F) ≤3 month -20 °- +45 ° (-4–113 °F) ≤6 month -20°- +35 ° (-4–95 °F) Relative humidity 5 %~95 % Dimension (L × W × H) 210.0 x 105.0 x 8.0 mm (8.3 x 4.1 x 0.30 in.) Weight 0.28 kg (0.
Overview CAUTION: The charging cable can only be used in areas not are accessible to the patient, such as in the Bucky. Wireless Communication Item Specifications Wireless Frequency Range 2.412~2.472GHz, 5.18~5.22GHz; 5.745~5.85GHz Data Transmission Power • • • • • • • 13dBm (Typ.) @802.11a 16dBm (Typ.) @802.11b 14dBm (Typ.) @802.11g 13dBm (Typ.) @802.11n HT20 11dBm (Typ.) @802.11n HT40 16dBm@2.4GHz 13dBm@5.8GHz Wireless Modulation • • 802.11b: CCK, DQPSK, DBPSK 802.
Overview Mechanical Outlines AL4609 3-9 2021-09-21
Overview Use Environment Operating Temperature Temperature Change Humidity Atmospheric Pressure Pressure Change 5–35 °C < 1k/min 5 %–90 % RH 700–1060 hPa <10 kp/min (1 kp=1.0197E-5Pa) < 1k/min 5 %–95 % RH 700–1060 hPa <10 kp/min (1 kp=1.0197E-5Pa) (41–95 °F) Storage and Transportatio n -20–55 °C (-4–131 °F) Focus HD 43 detectors shall operate at a specified altitude of not more than 3000.0 m (9842.5 ft). The environment specific is only for the detector.
Overview Disposal CAUTION: Do not dispose of this product with your residential or commercial waste. Improper handling of this type of waste could have a negative impact on health and on the environment. Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic waste. Contact your local authorities for information about dropping off waste products for recycling.
FCC Regulations: Contains FCC ID：2ACHK-01070189 ⚫ This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. ⚫ This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
between the unit and the human body. Carry this device at least 0 mm away from your body to ensure RF exposure level compliant or lower to the reported level. IC Notice This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
Publication History Version Date Changes A 2021-07-08 First release B 2021-09-21 Updated: • • • • AL4609 Medical Equipment Classification Radio Frequency Compliance Cautions Product Specifications I 2021-09-21
Carestream Health, Inc. 150 Verona Street Rochester, NY, USA 14608 © Carestream Health, Inc., 2021 Made in China for Carestream Health, Inc. CARESTREAM is a trademark of Carestream Health. Pub. No. AL4609 Rev.
