User Manual for the Focus HD 35 Detector
Publication No. AL46082021-09-07
Supersedes:2021-07-08
Page 1: ...User Manual for the Focus HD 35 Detector Publication No AL4608 2021 09 07 Supersedes 2021 07 08...
Page 2: ...s 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 p...
Page 3: ...igence or fault Note Notes provide additional information such as expanded explanations hints or reminders Important Important highlights critical policy information that affects how you use this manu...
Page 4: ...ns 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 It is the responsibili...
Page 5: ...8 Correction and Calibration Template Generation 1 10 Intended Use 1 11 2 Operation Notes for Using 2 1 Symbols 2 2 Cautions 2 5 Detector Position 2 9 Panel Installation 2 10 Install the Detector Batt...
Page 6: ...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...
Page 7: ...aphic imaging IEC 62304 2006 AMD1 2015 Medical device software Software life cycle processes IEC 62366 1 2015 IEC 62366 2007 EN62366 2008 Medical devices Part 1 Application of usability engineering to...
Page 8: ...nd those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations and flicker IEC 61000 3 3 Compliance Electromagnetic...
Page 9: ...8 Hz 27 V m 450 430 470 FM 5 kHz deviation 1 kHz sine 28 V m 710 704 787 Pulse modulation 217 Hz 9 V m 745 780 810 800 960 Pulse modulation 18 Hz 28 V m 870 930 1720 1700 1990 Pulse modulation 217 Hz...
Page 10: ...ground IEC 61000 4 5 0 5 kV 1kV 2 kV Conducted disturbances induced by RF fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Voltage dips IEC 61000 4...
Page 11: ...gical equipment and the RF shielded room of a medical equipment system for magnetic resonance imaging where the intensity of electromagnetic disturbances is high Use of adjacent or stacked with other...
Page 12: ...result in increased emission or decreased immunity Battery Safety Standards Standards Description IEC 62133 2 2017 Secondary cells and batteries containing alkaline or other non acid electrolytes Saf...
Page 13: ...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 unde...
Page 14: ...ue by IEEE Std 1528 The FCC has granted an Equipment Authorization for this product with all reported SAR Levels evaluated as in compliance with the FCC RF exposure guidelines While there may be diffe...
Page 15: ...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...
Page 16: ...s in developing medical devices Pediatric Subgroup Approximate Age Range Newborn Neonate From birth to 1 month of age Infant Greater than 1 month to 2 years of age Child Greater than 2 to 12 years of...
Page 17: ...m 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 6 1m no Infant Age is between 1 month and 2 years 73 2 1m no Child Age is b...
Page 18: ...1 8m yes Extremities AP PA Very Low Birth Weight 50 1 1m no Low Birth Weight 55 1 1m no Newborn 57 1 1m no Infant 57 1 2 1m no Child 58 1 2 1m no Preadolescent 62 1 6 1m no Adolescent 62 2 1m no Adul...
Page 19: ...0 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 8 1 no Intended Operator All procedures should be carried out by an operator who has completed the prof...
Page 20: ...he product should be warmed up for 15 minutes before exposure or updating the gain map and defect map Make sure exposure rate is over 900 nGy s 70 kV Make sure the wave form of the energy going to the...
Page 21: ...ghtly dampened with a neutral detergent Do not use solvents such as alcohol thinner benzene acid and base It is recommended to use a waterproof non woven cover as the isolated layer between the detect...
Page 22: ...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 n...
Page 23: ...on 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...
Page 24: ...ic maintenance to ensure continued safe use of the equipment The equipment must be repaired only by authorized Service personnel The detector is fragile and contains glass Handle with care Dropping or...
Page 25: ...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 grounde...
Page 26: ...00 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 Be sure to securely hold the produ...
Page 27: ...nspection CAUTION Remove the power of the product before cleaning Never use alcohol ether and other flammable cleaning agent Never use methanol benzene and acid to avoid corrosion on the equipment CAU...
Page 28: ...Detector Position To prevent abnormal light lines place the detector behind the patient in the orientation shown below Operation AL4608 2 9 2021 09 07...
Page 29: ...r 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 M...
Page 30: ...ve 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 Power Indicator Power Indicator Lighting Status Status Batt...
Page 31: ...is OFF Link Indicator Power Indicator Lighting Status Description Off Power OFF Wired connection broken and wireless connection not ready Green On Wired connection is built Service mode Blue On Clien...
Page 32: ...d 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 Client mod...
Page 33: ...e Mode LED indicator blinks blue indicating that the detector is in AP mode 2 Press and release the Mode button The Mode LED indicator will blink from blue to green indicating that WIFI mode has switc...
Page 34: ...r 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 AL4...
Page 35: ...ortation 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 Insert the battery into the...
Page 36: ...um Iodide which is direct deposit Scope This manual contains information about the Focus HD 35 Information in the manual including the illustrations is based on a prototype If your system configuratio...
Page 37: ...ct Components Component Description Detector Item 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 but...
Page 38: ...ace C Guide block D Touch display Battery Charger Item Description Notes A Battery Interface A 8 pin battery connector for Focus 35C B Battery Interface B 7 pin battery connector for Focus HD 35 C Bat...
Page 39: ...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 AC power input Multiple batteries inserte...
Page 40: ...ies 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...
Page 41: ...84 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 Software AED Battery Item Specifications Model Battery KX Rated capacity Min 4700mAh Typ 49...
Page 42: ...ension 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 62 lb Battery Charger Item Specifications Model Charger Combo Simultaneous Charging 1 Battery Pack Full Charging Time 4 hr Rate...
Page 43: ...1g 13dBm Typ 802 11n HT20 11dBm Typ 802 11n HT40 16dBm 2 4GHz 13dBm 5 8GHz Wireless Modulation 802 11b CCK DQPSK DBPSK 802 11a g n 64QAM 16QAM QPSK BPSK 802 11ac 256QAM 64QAM 16QAM QPSK BPSK Wireless...
Page 44: ...Mechanical Outlines Overview AL4608 3 9 2021 09 07...
Page 45: ...5 90 RH 700 1060 hPa 10 kp min 1 kp 1 0197E 5Pa Storage and Transportatio n 20 55 C 4 131 F 1k min 5 95 RH 700 1060 hPa 10 kp min 1 kp 1 0197E 5Pa Focus HD 35 detectors shall operate at a specified al...
Page 46: ...e 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 In the European...
Page 47: ...ne or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different f...
Page 48: ...ator and your body This device and its antenna s must not be co located or operating in conjunction with any other antenna or transmitter Remarque IC Cet appareil est conforme aux Normes RSS d Industy...
Page 49: ...Publication History Version Date Changes A 2021 07 08 First release B 2021 09 07 Updated Medical Equipment Classification Radio Frequency Compliance Cautions Product Specifications AL4608 I 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...
