Related Manuals for Carestream Focus HD 35
Summary of Contents for Carestream Focus HD 35
- Page 1 User Manual for the Focus HD 35 Detector Publication No. AL4608 2021-09-07 Supersedes: 2021-07-08...
- Page 2 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.
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Page 3: Notices And Conventions
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. -
Page 4: Disclaimer
Carestream’s operating and maintenance instructions. • Carestream shall not be liable for any damage or loss arising from the use of any options or consumable products other than those dedicated as original products by Carestream. -
Page 5: Table Of Contents
Contents Notices and Conventions Disclaimer............................-iv 1 Safety and Regulatory Information Medical Equipment Classification....................1-1 Standards............................1-2 Emissions and Immunity Compliance to the IEC60601-1-2 Standard........1-3 Battery Safety Standards......................1-7 Radio Frequency Compliance......................1-8 Correction and Calibration Template Generation..............1-10 Intended Use..........................1-11 2 Operation Notes for Using.......................... -
Page 6: Safety And Regulatory Information
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... -
Page 7: Standards
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... - Page 8 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment RF emissions The Focus HD 35 Detector uses RF energy CISPR 11 only for its internal function. Therefore, its Group 1, Class B RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
- Page 9 Safety and Regulatory Information Proximity Fields From RF Wireless Communications Equipment Test Levels Test Frequency Band (MHz) (MHz) Professional healthcare facility environment 380–390 Pulse modulation 18 Hz, 27 V/m 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...
- Page 10 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 IEC 61000-4-5 ±0.5 kV, ±1 kV Surges Line-to-line IEC 61000-4-5 ±0.5 kV, ±1kV, ±2 kV Surges Line-to-ground Conducted disturbances...
- Page 11 If such use is necessary, this equipment and the other equipment should be observed to verify correct operation. requires special precautions regarding EMC and needs to be installed only by Carestream or authorized personnel and put into service according to EMC information provided in the user manual. 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 , including...
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Page 12: Battery Safety Standards
Nevertheless, special precautions need to be observed. The use of accessories, transmitters, and cables other than those specified by this user manual, with the exception of accessories and cables sold by Carestream as replacement parts for inner components, may result in increased emission or decreased immunity. -
Page 13: Radio Frequency Compliance
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) ANSI C63.4 (2014) U.S.A 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... - Page 14 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: •...
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Page 15: Correction And Calibration Template Generation
Safety and Regulatory Information cm between the radiator and your body. This device and its antenna(s) must not be co- located 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. -
Page 16: Intended Use
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. - Page 17 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 Patient Size Grid Very Low Birth Weight (Less than 1.5 Kg) Low Birth Weight (Between 1.5 and 2.5 Kg)
- Page 18 Safety and Regulatory Information Body Parts Patient Size Grid Very Low Birth Weight Low Birth Weight Newborn Infant Child Chest PA/AP Preadolescent Adolescent Adult Small 1.8m Adult Medium 1.8m Adult Large 1.8m Very Low Birth Weight Low Birth Weight Newborn Infant Child Extremities AP/PA...
- Page 19 Safety and Regulatory Information Adult Extremities List Grid Femur - AP Femur - Lateral Hand - PA Hand - oblique Humerus - AP Humerus - Lateral Knee - AP Knee - Lateral Wrist - PA Wrist - Lateral Intended Operator All procedures should be carried out by an operator who has completed the professional training offered by the company’s customer service staff.
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Page 20: Operation
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. -
Page 21: Symbols
Symbols and Conventions Labels and Markings on the Equipment This indicates the name and address of the manufacturer. This indicates the name and address of a Carestream authorized representative in the European-Union. Follow the instructions for use. Handle with care. - Page 22 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. AL4608 2021-09-07...
- Page 23 Operation This indicates the stacking limit number. Rx only Device is for prescription use only. IP56 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.
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Page 24: Cautions
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. - Page 25 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.
- Page 26 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.
- Page 27 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.
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Page 28: Detector Position
Operation Detector Position To prevent abnormal light lines, place the detector behind the patient in the orientation shown below. AL4608 2021-09-07... -
Page 29: Panel Installation
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. -
Page 30: Power On 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. - Page 31 Operation Status Power Indicator Lighting Status Battery Capacity DC Input Description Detector is Green Blinking ≥ 95 % Green and Orange Detector is < 95 % Blinking Link Indicator Power Indicator Lighting Status Description • Power OFF • Wired connection broken and wireless connection not ready Wired connection is built (Service mode) Green On...
- Page 32 Operation Status Indicator Power Indicator Lighting Status Description Detector is OFF Green ON Exposure is allowed Green Blinking Detector is in WIFI mode switch status Orange On Error Mode Indicator Power Indicator Lighting Status Description Blue On Client mode is enabled 1.
- Page 33 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. The Mode LED indicator blinks blue indicating that the detector is in AP mode. Green Blinking 2.
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Page 34: Install The Detector Battery Charger
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. 2-15 AL4608 2021-09-07... -
Page 35: Detector Battery Activation
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 1. Power on the charger. 2. -
Page 36: Overview
It is designed to provide the high quality radiography image which contains an active matrix of 3500 × 4300 with 100 um pixel pitch. The scintillator of the Focus HD 35 is CsI (Caesium Iodide) which is direct deposit. -
Page 37: Components And Specifications
Overview Components and Specifications Product Components Component Description Detector Item Description Notes DC input interface Mode button Detector status indicator Mode indicator Link indicator Power level indicator Power button AL4608 2021-09-07... - Page 38 Battery label Battery interface Guide block Touch display Battery Charger Item Description Notes Battery Interface A 8 pin battery connector for Focus 35C Battery Interface B 7 pin battery connector for Focus HD 35 Battery Interface C Not used AL4608 2021-09-07...
- Page 39 Overview Item Description Notes Indicator The indicator definition is as follow The limit ball plug Hand Pull Position AC Jack 220 V (ac) input Battery Charger Indicator Item Name Power Indicator Charging Indicator Charge Full Indicator X Indicator Operating Status All off No power input A indicator on...
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Page 40: Product Specifications
Two or more batteries charging cannot be charged at the same time. Charging will automatically stop if more than one battery is inserted. Product Specifications Detector Item Specifications Model Focus HD 35 Image Sensor a-Si (amorphous silicon) TFT Scintillator Pixel Size 100 µm Fill Factor... - Page 41 Overview Item Specifications Image Transfer WiFi Wireless : IEEE802.11 a/b/g/n/ac Power Consumption Max. 35.5W Dimension (L × W × H) 460.0 x 384.0 x 15.0 mm (18.1 x 15.1 x 0.6 in.) Weight (with one battery) 3.1 kg (6.6 lb) Panel Protection IP56 Trigger Mode...
- Page 42 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 ×...
- Page 43 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 •...
- Page 44 Overview Mechanical Outlines AL4608 2021-09-07...
- Page 45 700–1060 hPa <10 kp/min -20–55 °C Transportatio (1 kp=1.0197E-5Pa) (-4–131 °F) Focus HD 35 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. 3-10 AL4608 2021-09-07...
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Page 46: Disposal
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. If collection systems are not available, call Carestream Customer Service for assistance. - Page 47 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. ⚫...
- Page 48 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...
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Page 49: Publication History
Publication History Version Date Changes 2021-07-08 First release 2021-09-07 Updated: • Medical Equipment Classification • Radio Frequency Compliance • Cautions • Product Specifications AL4608 2021-09-07... - Page 50 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. AL4608 Rev. B...