{"id":7664,"date":"2025-08-12T08:49:25","date_gmt":"2025-08-11T23:49:25","guid":{"rendered":"https:\/\/hansem.com\/?post_type=blog&#038;p=7664"},"modified":"2025-08-12T10:36:05","modified_gmt":"2025-08-12T01:36:05","slug":"%ec%9d%98%eb%a3%8c%ea%b8%b0%ea%b8%b0-ifu-%ec%8b%9c%ea%b0%81%ec%9e%90%eb%a3%8c-%ec%a0%84%eb%9e%b5","status":"publish","type":"blog","link":"https:\/\/hansem.com\/ko\/blog\/%ec%9d%98%eb%a3%8c%ea%b8%b0%ea%b8%b0-ifu-%ec%8b%9c%ea%b0%81%ec%9e%90%eb%a3%8c-%ec%a0%84%eb%9e%b5\/","title":{"rendered":"\uc0ac\uc6a9\uc790 \uc911\uc2ec\uc758 \uc758\ub8cc\uae30\uae30 IFU, \uc65c \uc2dc\uac01\uc790\ub8cc\uac00 \uc804\ub7b5\uc774 \ub418\ub294\uac00?"},"content":{"rendered":"\n<p>\uc124\uce58\ub098 \uc0ac\uc6a9\ubc95\uc744 \ud55c\ub208\uc5d0 \uc774\ud574\ud560 \uc218 \uc788\uac8c \ud574\uc8fc\ub294 \ud14c\ud06c\ub2c8\uceec \uc77c\ub7ec\uc2a4\ud2b8\uac00 \uc798 \uc801\uc6a9\ub41c \uc758\ub8cc\uae30\uae30 \uc0ac\uc6a9\uc124\uba85\uc11c\uc758 \uc7a5\uc810, \uc54c\uace0 \uacc4\uc2e0\uac00\uc694? \ubbf8\uad6d\uc744 \ube44\ub86f\ud55c \uc8fc\uc694 \uc2dc\uc7a5\uc5d0\uc11c\ub294 \uc808\ucc28\uc758 \uba85\ud655\uc131, \uc704\ud5d8 \uc815\ubcf4\uc758 \uc9c1\uad00\uc131, \ub2e4\uad6d\uc5b4 \uc77c\uad00\uc131\uc774 IFU\uc758 \ud544\uc218 \uc694\uac74\uc73c\ub85c \uc694\uad6c\ub429\ub2c8\ub2e4. \ud558\uc9c0\ub9cc \uc774\ub7ec\ud55c \uc694\uac74\uc740 \ub2e8\uc21c\ud55c \ud14d\uc2a4\ud2b8 \uc911\uc2ec \uad6c\uc131\ub9cc\uc73c\ub85c\ub294 \ucda9\uc871\ub418\uae30 \uc5b4\ub835\uc2b5\ub2c8\ub2e4. \uc774 \ubcf5\uc7a1\ud55c \uc694\uad6c\ub97c \ub9cc\uc871\uc2dc\ud0a4\ub294 \ud575\uc2ec \ud574\ubc95\uc774 \ubc14\ub85c, \u2018<strong>\uc0ac\uc6a9\uc790 \uc911\uc2ec \uc124\uacc4\u2019\ub97c \ubc18\uc601\ud55c \uc2dc\uac01\uc790\ub8cc(Visual Aids)<\/strong>\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ucd5c\uadfc, \ub9ce\uc740 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\ub4e4\uc774 \uc2dc\uac01\uc790\ub8cc\ub97c \ub2e8\uc21c\ud55c \ub514\uc790\uc778 \uc694\uc18c\uac00 \uc544\ub2c8\ub77c <strong>\uc81c\ud488 \uc0ac\uc6a9 \uc548\uc804\uc131\uc744 \ubcf4\uc7a5\ud558\uace0, \uc0ac\uc6a9\uc790 \uc624\ub958\ub97c \uc904\uc774\uba70, FDA\uc758 \uae30\ub300\ub97c \ucda9\uc871\ud558\uace0, \ud604\uc9c0\ud654 \ud6a8\uc728\uc131\uc744 \ub192\uc774\ub294 \ud544\uc218\uc801\uc778 \ub3c4\uad6c<\/strong>\ub85c \uc778\uc2dd\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub97c \uc2e4\ud604\ud558\uae30 \uc704\ud574 <a href=\"https:\/\/hansem.com\/ko\/\" target=\"_blank\" rel=\"noreferrer noopener\">\ud55c\uc0d8\uae00\ub85c\ubc8c<\/a>\uacfc <a href=\"https:\/\/awglaw.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">AWG(Amin Wasserman Gurnani LLP)<\/a>\ub294 \uaddc\uc81c \uc694\uad6c\uc0ac\ud56d\uacfc \ubc95\uc801 \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294 IFU\ub97c \uac1c\ubc1c\ud558\ub294 \uacf5\ub3d9 \uc194\ub8e8\uc158\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 \ub2e4\uad6d\uc5b4 \ubb38\uc11c\ud654\uc640 \uc0ac\uc6a9\uc790 \uc911\uc2ec IFU \uac1c\ubc1c\uc5d0 \ub300\ud55c \uae4a\uc740 \uc804\ubb38\uc131\uc744 \ubcf4\uc720\ud558\uace0 \uc788\uc73c\uba70, AWG\ub294 FDA \ub77c\ubca8\ub9c1 \uaddc\uc815, \uc81c\ucd9c \uc808\ucc28 \ubc0f \ubc95\uc801 \ub9ac\uc2a4\ud06c\uc5d0 \ub300\ud55c \ub3c5\ud2b9\ud55c \ubc95\ub960\uc801 \uc778\uc0ac\uc774\ud2b8\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \ub450 \ud68c\uc0ac\ub294 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\ub4e4\uc774 \uaddc\uc81c \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\uc2dc\ud0a4\ub294 \ub3d9\uc2dc\uc5d0, \ud6a8\uacfc\uc801\uc774\uace0 \ubc29\uc5b4 \uac00\ub2a5\ud55c IFU\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ubcf8 \uae00\uc5d0\uc11c\ub294 \uc758\ub8cc\uae30\uae30 IFU\uc5d0 \uc2dc\uac01\uc790\ub8cc\ub97c \uc804\ub7b5\uc801\uc73c\ub85c \ub3c4\uc785\ud588\uc744 \ub54c \uae30\ub300\ud560 \uc218 \uc788\ub294 \ub2e4\uc12f \uac00\uc9c0 \ud6a8\uacfc, \uae00\ub85c\ubc8c \uae30\uc5c5\ub4e4\uc758 \uc2e4\uc81c \uc0ac\ub840, \uadf8\ub9ac\uace0 \uc774\ub97c \uc2e4\ud604\ud558\ub294 \ud55c\uc0d8\uae00\ub85c\ubc8c\uc758 \ud14c\ud06c\ub2c8\uceec \uc77c\ub7ec\uc2a4\ud2b8\ub808\uc774\uc158 \uc5ed\ub7c9\uc744 \uc18c\uac1c\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-\uc989\uac01\uc801\uc778-\uc704\ud5d8-\uc778\uc2dd\uacfc-\uc548\uc804-\ud589\ub3d9-\uc720\ub3c4\">1. \uc989\uac01\uc801\uc778 \uc704\ud5d8 \uc778\uc2dd\uacfc \uc548\uc804 \ud589\ub3d9 \uc720\ub3c4<\/h3>\n\n\n\n<p>\uc2dc\uac01\uc790\ub8cc\ub294 \uc0ac\uc6a9\uc790\uc758 <strong>\uc8fc\uc758\ub97c \ub04c\uace0, \uc704\ud5d8 \ud589\ub3d9\uc744 \uc9c1\uad00\uc801\uc73c\ub85c \ucc28\ub2e8\ud558\ub294 \uac00\uc7a5 \ud6a8\uacfc\uc801\uc778 \uc218\ub2e8<\/strong>\uc785\ub2c8\ub2e4.<br>\ud2b9\ud788 \uc751\uae09\uc0c1\ud669\uc774\ub098 \ubc18\ubcf5 \uc0ac\uc6a9 \ud658\uacbd\uc5d0\uc11c\ub294, \uae34 \ud14d\uc2a4\ud2b8 \uc124\uba85\ubcf4\ub2e4 <strong>\uae08\uc9c0 \uc2ec\ubcfc, \uc8fc\uc758 \uc77c\ub7ec\uc2a4\ud2b8, \uc0c9\uc0c1 \ub300\ube44<\/strong> \ub4f1 \uc2dc\uac01\uc801 \uc7a5\uce58\ub97c \ud1b5\ud574 <strong>\uc989\uac01\uc801\uc774\uace0 \ubcf8\ub2a5\uc801\uc778 \ubc18\uc751<\/strong>\uc744 \uc720\ub3c4\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uae08\uc9c0 \ub3d9\uc791\uc5d0 \ub300\ud55c <strong>\uc9c1\uad00\uc801\uc778 \uc544\uc774\ucf58\uacfc \uc77c\ub7ec\uc2a4\ud2b8<\/strong><\/li>\n\n\n\n<li>\uc704\ud5d8 \uad6c\uc5ed\uc744 <strong>\uc0c9\uc0c1\u00b7\ud615\uc0c1\uc73c\ub85c \uac15\uc870<\/strong>\ud574 \uc2dc\uc120 \uc720\ub3c4<\/li>\n\n\n\n<li><strong>\uc798\ubabb\ub41c \uc0ac\uc6a9 \ubc29\uc2dd vs. \uc62c\ubc14\ub978 \uc0ac\uc6a9 \ubc29\uc2dd<\/strong>\uc744 \ube44\uad50 \uc2dc\uac01\ud654\ud558\uc5ec \uc2e4\uc218 \uc608\ubc29<\/li>\n<\/ul>\n\n\n\n<p>\uc774\ub294 \uc0ac\uc6a9\uc790\uc5d0\uac8c &#8216;\uc0dd\uac01\ud558\uac8c \ud558\uae30&#8217;\ubcf4\ub2e4 &#8216;\uc989\uc2dc \ubc18\uc751\ud558\uac8c \ud558\ub294&#8217; \uc548\uc804 \ucee4\ubba4\ub2c8\ucf00\uc774\uc158 \ubc29\uc2dd\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-\uc0ac\uc6a9\uc790-\uce5c\ud654\uc131-\ud655\ubcf4\">2. \uc0ac\uc6a9\uc790 \uce5c\ud654\uc131 \ud655\ubcf4<\/h3>\n\n\n\n<p>IFU\ub294 \uc758\uc0ac\ub098 \uc5d4\uc9c0\ub2c8\uc5b4\ub9cc\uc744 \uc704\ud55c \ubb38\uc11c\uac00 \uc544\ub2d9\ub2c8\ub2e4. <strong>\uc77c\ubc18 \uc0ac\uc6a9\uc790, \uace0\ub839\uce35, \uc601\uc5b4 \ube44\uc6d0\uc5b4\ubbfc<\/strong> \ub4f1 \ub2e4\uc591\ud55c \uc0ac\uc6a9\uc790\uce35\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uc774\ub4e4\uc5d0\uac8c\ub294 <strong>\ub2e8\uacc4\ubcc4\ub85c \uc2dc\uac01\ud654\ub41c \uc124\uba85<\/strong>\uc774 \uac00\uc7a5 \ud6a8\uc728\uc801\uc778 \uc548\ub0b4 \ubc29\uc2dd\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ubc84\ud2bc \uc870\uc791, \uad6c\uc131\ud488 \uc870\ub9bd, \uc138\ucc99 \uc808\ucc28 \ub4f1\uc744 <strong>\uc21c\uc11c\ub3c4 \uae30\ubc18 \uc77c\ub7ec\uc2a4\ud2b8<\/strong>\ub85c \uc548\ub0b4<\/li>\n\n\n\n<li>\ubcf5\uc7a1\ud55c \uc808\ucc28\ub97c \uc2dc\ub098\ub9ac\uc624 \ud615\ud0dc\ub85c \uc7ac\uad6c\uc131\ud558\uc5ec <strong>\ud589\ub3d9 \ud750\ub984 \uc911\uc2ec\uc73c\ub85c \uc804\ub2ec<\/strong><\/li>\n\n\n\n<li>\uc0ac\uc6a9 \uacbd\ud5d8\uc774 \uc5c6\ub294 \uc0ac\ub78c\ub3c4 <strong>\ub9e4\ub274\uc5bc \uc5c6\uc774 \uc81c\ud488\uc744 \uc0ac\uc6a9\ud560 \uc218 \uc788\ub294 \uc218\uc900<\/strong>\uc758 \uc9c1\uad00\uc801 \uad6c\uc131<\/li>\n<\/ul>\n\n\n\n<p>\ud2b9\ud788 \uac00\uc815\uc6a9 \uc790\uac00 \uc0ac\uc6a9 \uc758\ub8cc\uae30\uae30\uc758 \uacbd\uc6b0, \uc2dc\uac01\uc790\ub8cc \uc911\uc2ec\uc758 IFU\uac00 \uc81c\ud488 \ucc44\ud0dd\uc5d0 \uacb0\uc815\uc801\uc778 \uc5ed\ud560\uc744 \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-\ubc88\uc5ed-\ud6a8\uc728-\ud5a5\uc0c1\uacfc-\ucf58\ud150\uce20-\uc77c\uad00\uc131-\uc720\uc9c0\">3. \ubc88\uc5ed \ud6a8\uc728 \ud5a5\uc0c1\uacfc \ucf58\ud150\uce20 \uc77c\uad00\uc131 \uc720\uc9c0<\/h3>\n\n\n\n<p>\uae00\ub85c\ubc8c \uc9c4\ucd9c\uc744 \uc704\ud55c IFU\ub294 \ub300\ubd80\ubd84 <strong>\ub2e4\uc218\uc758 \uc5b8\uc5b4\ub85c<\/strong> <strong>\ubc88\uc5ed<\/strong>\ub429\ub2c8\ub2e4. \uc774\ub54c \uc2dc\uac01\uc790\ub8cc\ub97c \uc801\uadf9 \ud65c\uc6a9\ud558\uba74 \ud14d\uc2a4\ud2b8 \uc591\uc744 \uc904\uc774\uace0, <strong>\uc5b8\uc5b4\uc5d0 \uad6c\uc560\ubc1b\uc9c0 \uc54a\ub294 \ucf58\ud150\uce20<\/strong>\ub85c \ud45c\uc900\ud654\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\ud14d\uc2a4\ud2b8 \ubcfc\ub968 15~30% \uc808\uac10<\/strong>, \ubc88\uc5ed \ube44\uc6a9 \ubc0f \uc2dc\uac04 \ub2e8\ucd95<\/li>\n\n\n\n<li>\uadf8\ub9bc \uae30\ubc18 \uc124\uba85\uc740 \uc5b8\uc5b4\ubcc4 <strong>\ubc88\uc5ed \uc624\ub958 \uac00\ub2a5\uc131 \ucd5c\uc18c\ud654<\/strong><\/li>\n\n\n\n<li>\ub3d9\uc77c \uc2dc\uac01\uc790\ub8cc\ub97c \ubaa8\ub4e0 \uc5b8\uc5b4\uc5d0 \uc7ac\uc0ac\uc6a9\ud558\uc5ec <strong>\ube0c\ub79c\ub4dc \uc77c\uad00\uc131 \uc720\uc9c0<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\ub9ac\ubdf0\uc640 \uc2b9\uc778 \uc18d\ub3c4\uac00 \ube68\ub77c\uc9c0\uace0, <strong>\ud604\uc9c0 \uc720\ud1b5 \uc77c\uc815\ub3c4 \uc55e\ub2f9\uae38 \uc218 \uc788\ub294<\/strong> \uac04\uc811 \ud6a8\uacfc\ub3c4 \ud07d\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-4-\ubcf5\uc7a1\ud55c-\uc808\ucc28\uc758-\uad6c\uc870\ud654\uc640-\uaddc\uc81c-\ub300\uc751\ub825-\ud655\ubcf4\">4. \ubcf5\uc7a1\ud55c \uc808\ucc28\uc758 \uad6c\uc870\ud654\uc640 \uaddc\uc81c \ub300\uc751\ub825 \ud655\ubcf4<\/h3>\n\n\n\n<p>\uc124\uce58, \uc720\uc9c0\ubcf4\uc218, \uc138\ucc99, \ubd80\ud488 \uad50\uccb4 \ub4f1\uc740 <strong>\ub2e8\uacc4\ubcc4 \uc808\ucc28\ub97c \uc774\ud574\ud558\uace0 \uc7ac\ud604\ud558\ub294 \uac83<\/strong>\uc774 \ud575\uc2ec\uc785\ub2c8\ub2e4. \uc774\ub7f0 \ubcf5\uc7a1\ud55c \uc791\uc5c5\uc740 \ub2e8\uc21c\ud55c \ubb38\uc7a5 \uc124\uba85\uc73c\ub85c\ub294 \uc774\ud574\uac00 \uc5b4\ub835\uace0, \uc0ac\uc6a9\uc790\ub9c8\ub2e4 \ud574\uc11d\uc774 \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc5b4 <strong>\uc791\uc5c5 \uc624\ub958, \uc7a5\ube44 \uc190\uc0c1, \uc0ac\uc6a9\uc790 \ubd88\ub9cc<\/strong>\uc73c\ub85c \uc774\uc5b4\uc9c8 \uc704\ud5d8\uc774 \ud07d\ub2c8\ub2e4. \uc774\ub97c \ubc29\uc9c0\ud558\uae30 \uc704\ud574 \ud544\uc694\ud55c \uac83\uc774 \ubc14\ub85c <strong>\ub2e4\uc774\uc5b4\uadf8\ub7a8, \uc808\ucc28 \uc77c\ub7ec\uc2a4\ud2b8, \ud750\ub984\ub3c4 \uae30\ubc18 \uc2dc\uac01\uc790\ub8cc<\/strong>\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc791\uc5c5 \ud750\ub984\uc5d0 \ub530\ub978 <strong>\uc21c\ucc28\uc801 \uc548\ub0b4<\/strong>\ub85c \uc7ac\ud604\uc131 \ud655\ubcf4<\/li>\n\n\n\n<li>\uac01 \ub2e8\uacc4\uc758 <strong>\ub3c4\uad6c \uc0ac\uc6a9, \ubc29\ud5a5, \uc21c\uc11c<\/strong>\ub97c \uc774\ubbf8\uc9c0\ub85c \uba85\ud655\ud788 \ud45c\ud604<\/li>\n\n\n\n<li>\uc0ac\uc6a9\uc790 \uc219\ub828\ub3c4\uc640 \uad00\uacc4\uc5c6\uc774 <strong>\ub3d9\uc77c\ud55c \uacb0\uacfc\ub97c \uc720\ub3c4\ud558\ub294 \ud45c\uc900\ud654 \ub3c4\uad6c<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\ub610\ud55c, <strong>FDA Human Factors Guidance<\/strong>\uc5d0\uc11c\ub3c4 \ubcf5\uc7a1\ud55c \uc808\ucc28\uc5d0\uc11c\uc758 \uc0ac\uc6a9\uc790 \uc624\ub958 \ubc29\uc9c0\ub97c \uac15\uc870\ud558\uace0 \uc788\uc73c\uba70, \uc2dc\uac01\uc790\ub8cc\ub294 <strong>\uc0ac\uc6a9 \ud589\ub3d9 \uc124\uacc4\uc758 \uc77c\ubd80\uc774\uc790 \uaddc\uc81c \ub300\uc751\uc758 \uac1d\uad00\uc801 \uc124\uba85 \uc218\ub2e8<\/strong>\uc73c\ub85c \uae30\ub2a5\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc2e4\uc81c\ub85c <strong>Philips Healthcare<\/strong>\ub294 Allura \ubc0f Azurion \uc2dc\uc2a4\ud15c\uc758 \ud658\uc790 \ud14c\uc774\ube14 \uc0ac\uc6a9 \uc911 <strong>\ub9e4\ud2b8\ub9ac\uc2a4\uc758 \ubd80\uc815\ud655\ud55c \uc704\uce58\uc640 \ubbf8\ub044\ub7ec\uc9d0<\/strong>\uc73c\ub85c \uc778\ud574 \ub099\uc0c1 \uc704\ud5d8\uc774 \ubc1c\uc0dd\ud558\uc790, \uae30\uc874 \uc0ac\uc6a9\uc124\uba85\uc11c\uc5d0 \uc808\ucc28 \uc911\uc2ec\uc758 \ucd94\uac00 \uc9c0\uce68\uacfc Quick Reference Card(\uc2dc\uac01\uc790\ub8cc \ud3ec\ud568)\ub97c \uae34\uae09 \ubc30\ud3ec\ud558\uc600\uc2b5\ub2c8\ub2e4. \uc774\ub294 FDA\uc5d0\uc11c <strong>Class I(\uac00\uc7a5 \uc2ec\uac01\ud55c \ub4f1\uae09)<\/strong> \ub9ac\ucf5c\ub85c \ubd84\ub958\ub418\uc5c8\uc73c\uba70, \uc2dc\uac01\uc790\ub8cc\uac00 \ub2e8\uc21c\ud55c \ubcf4\uc870 \uc218\ub2e8\uc774 \uc544\ub2c8\ub77c <strong>\ud658\uc790 \uc548\uc804\uacfc \uaddc\uc81c \ub300\uc751\uc744 \uc704\ud55c \ud575\uc2ec \ub3c4\uad6c<\/strong>\ub85c \ud65c\uc6a9\ub41c \ub300\ud45c\uc801\uc778 \uc0ac\ub840\uc785\ub2c8\ub2e4. (FDA \uacf5\uc2dd <a href=\"https:\/\/www.fda.gov\/medical-devices\/medical-device-recalls\/patient-table-correction-philips-updates-use-instructions-allura-and-azurion-systems-due-patient?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noreferrer noopener\">\ub9ac\ucf5c \uacf5\uc9c0 \ubcf4\uae30<\/a>)<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-5-\ube0c\ub79c\ub4dc-\uc804\ubb38\uc131-\ubc0f-\uc2e0\ub8b0\ub3c4-\uac15\ud654\">5. \ube0c\ub79c\ub4dc \uc804\ubb38\uc131 \ubc0f \uc2e0\ub8b0\ub3c4 \uac15\ud654<\/h3>\n\n\n\n<p>\uace0\ud488\uc9c8\uc758 \uc2dc\uac01\uc790\ub8cc\ub294 \ub2e8\uc9c0 \uc124\uba85 \uc218\ub2e8\uc774 \uc544\ub2c8\ub77c, <strong>\ube0c\ub79c\ub4dc \uc774\ubbf8\uc9c0\uc758 \uc77c\ubd80<\/strong>\ub85c \uc791\uc6a9\ud569\ub2c8\ub2e4. \uad6c\ub9e4 \uacb0\uc815\uc790\ub098 \uc758\ub8cc\uae30\uad00 \ud30c\ud2b8\ub108\ub294 IFU\ub97c \ud1b5\ud574 \uc81c\ud488\uc758 <strong>\uc804\ubb38\uc131, \uc548\uc815\uc131, \uc0ac\uc6a9\uc790 \uc874\uc911 \uc218\uc900<\/strong>\uc744 \ud310\ub2e8\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ud1b5\uc77c\ub41c \uc2a4\ud0c0\uc77c\uc758 \uadf8\ub798\ud53d \uc2dc\uc2a4\ud15c \u2192 <strong>\uc804\ubb38\uc801\uc778 \uc778\uc0c1 \uc81c\uacf5<\/strong><\/li>\n\n\n\n<li><strong>\uc758\ub8cc\uae30\uae30\uc758 \uace0\uae09\ud654\u00b7\ub514\uc9c0\ud138\ud654 \ud750\ub984\uc5d0 \ubd80\ud569\ud558\ub294 \ucf58\ud150\uce20 \uad6c\uc131<\/strong><\/li>\n\n\n\n<li>\ub2e4\uc591\ud55c \ud615\uc2dd(PDF, \uc6f9, \uc571, \uc601\uc0c1)\uc73c\ub85c <strong>\uba40\ud2f0\ucc44\ub110 \ud65c\uc6a9 \uac00\ub2a5<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uae00\ub85c\ubc8c-\uc758\ub8cc\uae30\uae30-\uc81c\uc870\uc0ac\uc758-\uc2e4\uc81c-\uc0ac\ub840\">\uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uc758 \uc2e4\uc81c \uc0ac\ub840<\/h3>\n\n\n\n<p>\uc2dc\uac01\uc790\ub8cc \uc911\uc2ec\uc758 IFU\ub294 \ub2e8\uc21c\ud55c \ub514\uc790\uc778 \uac1c\uc120\uc774 \uc544\ub2c8\ub77c, \uc81c\ud488\uc758 \uc548\uc804\uc131 \uac15\ud654, \ube0c\ub79c\ub4dc \uc2e0\ub8b0\ub3c4 \uc81c\uace0, \uae00\ub85c\ubc8c \uaddc\uc81c \ub300\uc751\uc744 \uace0\ub824\ud55c \uc804\ub7b5\uc801 \uc120\ud0dd\uc785\ub2c8\ub2e4. \uc774\ubbf8 \ub9ce\uc740 \uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \uae30\uc5c5\ub4e4\uc774 \uc774 \ubc29\uc2dd\uc744 \uc801\uadf9\uc801\uc73c\ub85c \ub3c4\uc785\ud558\uace0 \uc788\uc73c\uba70, \uc77c\ubc18 \uc0ac\uc6a9\uc790\uc5d0\uac8c\ub3c4 \uc798 \uc54c\ub824\uc9c4 \ub300\ud45c \uc0ac\ub840\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>Medtronic\uc740 \uc790\uac00\uc8fc\uc0ac\uae30, \uc778\uc290\ub9b0 \ud38c\ud504 \ub4f1 \ud658\uc790\uc6a9 \uc758\ub8cc\uae30\uae30\uc5d0 \ub2e8\uacc4\ubcc4 \uc77c\ub7ec\uc2a4\ud2b8\uc640 \uac04\uacb0\ud55c \ub3c4\uc2dd\ud654\ub97c \uc801\uc6a9\ud558\uc5ec, \ub204\uad6c\ub098 \uc9c1\uad00\uc801\uc73c\ub85c \uc774\ud574\ud560 \uc218 \uc788\ub294 IFU\ub97c \uc6b4\uc601\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ub2e8\uacc4\ubcc4 \ud53d\ud1a0\ub9ac\uc5bc \uad6c\uc131, \uc2e4\ubb3c \uc0ac\uc9c4\uacfc \ub3c4\uc2dd\uc758 \uc870\ud569, \ud654\uba74 \ucea1\ucc98, \uc544\uc774\ucf58\uacfc \uac15\uc870 \ubc15\uc2a4, QR \ucf54\ub4dc \uc5f0\uacc4 \ub4f1 \ub2e4\uc591\ud55c \uc2dc\uac01\uc801 \uc7a5\uce58\ub97c \ud65c\uc6a9\ud574 \ubcf5\uc7a1\ud55c \uc0ac\uc6a9 \uc808\ucc28\ub97c \uc9c1\uad00\uc801\uc73c\ub85c \uc548\ub0b4\ud569\ub2c8\ub2e4. <a href=\"https:\/\/resources.cloud.medtronic-diabetes.com\/sites\/prd\/files\/documents\/2023-02\/mm780g_g4s_quick_start_guide_lr_za.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\uc0ac\ub840 \ubcf4\uae30<\/a><\/p>\n\n\n\n<p>Philips\ub294 \uc790\uc0ac \uc2dc\uc2a4\ud15c\uc758 \uc0ac\uc6a9\uc790 \uc124\uba85\uc11c\uc5d0\uc11c \ub2e4\uc218\uc758 \uc2e4\uc81c \uc0ac\uc9c4\uc744 \ud1b5\ud574 \ud14c\uc774\ube14 \ubc0f \ub9e4\ud2b8\ub9ac\uc2a4 \uc124\uce58\uc640 \uc6c0\uc9c1\uc784 \uc0c1\ud669\uc744 \uc9c1\uad00\uc801\uc73c\ub85c \uc124\uba85\ud558\uace0 \uc8fc\uc758\u00b7\uacbd\uace0 \uc544\uc774\ucf58 \uc0bd\uc785\uc73c\ub85c \ud5ec\uc2a4\ucf00\uc5b4 \ud658\uacbd\uc5d0\uc11c\uc758 \uc548\uc804 \ud589\ub3d9\uc744 \uccb4\uacc4\uc801\uc73c\ub85c \uc548\ub0b4\ud569\ub2c8\ub2e4. \uc774\ub7f0 \uad6c\uc131\uc740 \ubcf5\uc7a1\ud55c \uc758\ub8cc\ud589\ub3d9\uc744 \u2018\ubcf4\uace0 \ub530\ub77c\ud560 \uc218 \uc788\ub294\u2019 \uc218\uc900\uc73c\ub85c \uad6c\uc870\ud654\ud55c \ub300\ud45c \uc0ac\ub840\uc774\uba70, <a href=\"https:\/\/www.documents.philips.com\/assets\/Instruction%20for%20Use\/20250710\/b709351d2fe140e48296b316006628ab.pdf?feed=ifu_docs_feed\" target=\"_blank\" rel=\"noreferrer noopener\">\ub9c1\ud06c\ub41c \ub9e4\ub274\uc5bc<\/a>\uc5d0\uc11c\ub3c4 \ub2e8\uacc4\ubcc4 \uc0ac\uc9c4\uacfc \uc544\uc774\ucf58\uc758 \ud65c\uc6a9\uc774 \ub208\uc5d0 \ub755\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774\ucc98\ub7fc \uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\ub4e4\uc740 \uc81c\ud488 \ud2b9\uc131\uacfc \uc0ac\uc6a9\uc790 \ub300\uc0c1\uc5d0 \ub530\ub77c \ub2e4\uc591\ud55c \ud615\ud0dc\uc758 \uc2dc\uac01\uc790\ub8cc \uc804\ub7b5\uc744 \uc801\uc6a9\ud558\uace0 \uc788\uc73c\uba70, \uc774\ub294 \ub2e8\uc21c\ud55c \uc815\ubcf4 \uc804\ub2ec\uc744 \ub118\uc5b4, \uc0ac\uc6a9\uc790 \uacbd\ud5d8(UX)\uc744 \uc124\uacc4\ud558\uace0, \uaddc\uc81c \ub300\uc751\uacfc \uc6b4\uc601 \ud6a8\uc728\uc131\uc744 \ub3d9\uc2dc\uc5d0 \ud655\ubcf4\ud558\ub294 \uc218\ub2e8\uc73c\ub85c \uc790\ub9ac\uc7a1\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\ud55c\uc0d8\uae00\ub85c\ubc8c\uc758-\ud14c\ud06c\ub2c8\uceec-\uc77c\ub7ec\uc2a4\ud2b8-\uc5ed\ub7c9\">\ud55c\uc0d8\uae00\ub85c\ubc8c\uc758 \ud14c\ud06c\ub2c8\uceec \uc77c\ub7ec\uc2a4\ud2b8 \uc5ed\ub7c9<\/h3>\n\n\n\n<p>\ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 \uc758\ub8cc\uae30\uae30 IFU \uc81c\uc791\uc5d0 \ud2b9\ud654\ub41c <strong>\ud14c\ud06c\ub2c8\uceec \uc77c\ub7ec\uc2a4\ud2b8 \uc804\ubb38\ud300<\/strong>\uc744 \ubcf4\uc720\ud558\uace0 \uc788\uc73c\uba70, <strong>\uc81c\ud488 \uad6c\uc870, \uc791\ub3d9 \ud750\ub984, \uc704\ud5d8 \uacbd\uace0, \uc815\ubcf4 \ubd84\ub958<\/strong>\uae4c\uc9c0 IFU \uc804\ubc18\uc744 \uc2dc\uac01\uc801\uc73c\ub85c \uc124\uacc4\ud569\ub2c8\ub2e4. \ud55c\uc0d8\uae00\ub85c\ubc8c\uc758 \u2018<a href=\"https:\/\/hansem.com\/ko\/blog\/%ed%85%8c%ed%81%ac%eb%8b%88%ec%bb%ac-%ec%9d%bc%eb%9f%ac%ec%8a%a4%ed%8a%b8-%ec%97%ad%ed%95%a0\/\" target=\"_blank\" rel=\"noreferrer noopener\">\ud14c\ud06c\ub2c8\uceec \uc77c\ub7ec\uc2a4\ud2b8\uc758 \uc5ed\ud560\uacfc \uc911\uc694\uc131<\/a>\u2019\uc5d0\uc11c \uc0ac\ub840\ub97c \uc0b4\ud3b4 \ubcf4\uc138\uc694.<\/p>\n\n\n\n<p><strong>\uc8fc\uc694 \uc5ed\ub7c9:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\uc124\uce58\u00b7\uc870\uc791\u00b7\uc720\uc9c0\uad00\ub9ac \uc808\ucc28 \uc77c\ub7ec\uc2a4\ud2b8<\/strong>: \ub2e8\uacc4\ubcc4 \ud750\ub984\uc744 \uc7a5\uba74 \uae30\ubc18 \uc774\ubbf8\uc9c0\ub85c \uc2dc\uac01\ud654<\/li>\n\n\n\n<li><strong>\uc81c\ud488 \uad6c\uc870\/\uae30\ub2a5 \uac1c\ub150 \uc774\ubbf8\uc9c0<\/strong>: \uc791\ub3d9 \uc6d0\ub9ac, \ub0b4\ubd80 \uad6c\uc131 \ub4f1 \ubcf5\uc7a1\ud55c \uac1c\ub150 \ub3c4\uc2dd\ud654<\/li>\n\n\n\n<li><strong>\uc0ac\uc6a9\uc790 \uc548\uc804 \uadf8\ub798\ud53d<\/strong>: \uc704\ud5d8 \uc694\uc18c \ubc0f \uae08\uc9c0 \ub3d9\uc791 \uc2dc\uac01\ud654<\/li>\n\n\n\n<li><strong>\uc544\uc774\ucf58 \ubc0f \ud53d\ud1a0\uadf8\ub7a8 \uc138\ud2b8 \ub514\uc790\uc778<\/strong>: \uc815\ubcf4 \uc720\ud615\ubcc4 \uc77c\uad00\uc131 \uc720\uc9c0<\/li>\n\n\n\n<li><strong>\uc0ac\uc6a9 \ud658\uacbd \uc2dc\ub098\ub9ac\uc624 \uad6c\uc131<\/strong>: \uc2e4\uc81c \uc0ac\uc6a9\uc790 \ub9e5\ub77d \ubc18\uc601\ud55c \uc77c\ub7ec\uc2a4\ud2b8 \uc124\uacc4<\/li>\n<\/ul>\n\n\n\n<p>\ud2b9\ud788 \ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 <strong>\uae30\ud68d, \uc6d0\uace0 \uc791\uc131, \ubc88\uc5ed, \ub514\uc790\uc778 \ud300\uc774 \ud55c \uacf5\uac04\uc5d0\uc11c \ud611\uc5c5<\/strong>\ud558\uc5ec <strong>\uae30\uc220\uc801 \uc815\ud655\uc131\uacfc \uc0ac\uc6a9\uc790 \uad00\uc810<\/strong>\uc744 \ub3d9\uc2dc\uc5d0 \ubc18\uc601\ud55c \uc2dc\uac01\uc790\ub8cc\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. \ub2e8\uc21c\ud788 \u2018\uadf8\ub9bc\uc744 \uadf8\ub9ac\ub294\u2019 \uac83\uc774 \uc544\ub2c8\ub77c, <strong>\uc81c\ud488 \uc0ac\uc6a9\uc744 \uc124\uacc4\ud558\uace0 \uaddc\uc81c \ub300\uc751\uc744 \uc124\uacc4\ud558\ub294 \ub3c4\uad6c<\/strong>\ub85c \uc2dc\uac01\uc790\ub8cc\ub97c \uc811\uadfc\ud569\ub2c8\ub2e4. \ub354 \uc790\uc138\ud55c \uc0ac\ub840\uc640 \ud504\ub85c\uc138\uc2a4\ub294 \u2018\ud55c\uc0d8\uae00\ub85c\ubc8c \ube14\ub85c\uadf8: \ub9e4\ub274\uc5bc \uc81c\uc791 \uc2dc \u2018<a href=\"https:\/\/hansem.com\/ko\/blog\/%EB%A7%A4%EB%89%B4%EC%96%BC-%EC%A0%9C%EC%9E%91-%EC%8B%9C%EA%B0%81%EC%A0%81-%EB%B3%B4%EC%A1%B0%EC%9E%A5%EC%B9%98\/\" target=\"_blank\" rel=\"noreferrer noopener\">\uc2dc\uac01\uc801 \ubcf4\uc870\uc7a5\uce58(Visual Aids)\u2019 \ud65c\uc6a9<\/a>\u2019\uc5d0\uc11c \ud655\uc778\ud558\uc2e4 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uacb0\ub860-\uc2dc\uac01\uc790\ub8cc\ub294-\ub514\uc790\uc778\uc774-\uc544\ub2cc-\uc804\ub7b5\uc785\ub2c8\ub2e4\">\uacb0\ub860: \uc2dc\uac01\uc790\ub8cc\ub294 \ub514\uc790\uc778\uc774 \uc544\ub2cc \uc804\ub7b5\uc785\ub2c8\ub2e4.<\/h3>\n\n\n\n<p>\uc758\ub8cc\uae30\uae30 IFU\uc5d0\uc11c\uc758 \uc2dc\uac01\uc790\ub8cc\ub294 \ub2e8\uc21c\ud55c \ubbf8\uc801 \uc694\uc18c\uac00 \uc544\ub2c8\ub77c, <strong>\uc0ac\uc6a9\uc790 \uc548\uc804, \uaddc\uc81c \ub300\uc751, \uae00\ub85c\ubc8c \ubc88\uc5ed \ud6a8\uc728, \ube0c\ub79c\ub4dc \uc774\ubbf8\uc9c0<\/strong>\ub97c \uc544\uc6b0\ub974\ub294 \uc804\ub7b5\uc801 \ub3c4\uad6c\uc785\ub2c8\ub2e4. <strong><\/strong><\/p>\n\n\n\n<p>\ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 <a href=\"https:\/\/awglaw.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">AWG(Amin Wasserman Gurnani LLP)<\/a>\uc640 \ud611\ub825\ud558\uc5ec, FDA \ub77c\ubca8\ub9c1 \uaddc\uc815, \uc81c\ucd9c \uc808\ucc28, \ubc95\uc801 \ub9ac\uc2a4\ud06c\ub97c \ubaa8\ub450 \ucda9\uc871\ud558\ub294 \uc2dc\uac01\uc801 \uc790\ub8cc\ub97c \uac1c\ubc1c\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4. \uaddc\uc81c \ub300\uc751\ubfd0\ub9cc \uc544\ub2c8\ub77c, \ud6a8\uacfc\uc801\uc774\uace0 \ubc29\uc5b4 \uac00\ub2a5\ud55c \uc2dc\uac01\uc801 \uc790\ub8cc\ub97c \ud1b5\ud574 \uadc0\uc0ac\uc758 IFU\uac00 \uac80\ud1a0 \uc900\ube44\uac00 \uc644\ub8cc\ub418\uace0, \ub9ac\uc2a4\ud06c \uc778\uc2dd\uc774 \ubc18\uc601\ub418\uba70, \uaddc\uc81c \uac80\ud1a0\ub97c \ud1b5\uacfc\ud560 \uc218 \uc788\ub3c4\ub85d \ub3d5\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc758\ub8cc\uae30\uae30 IFU \uc81c\uc791, \uc2dc\uac01\uc790\ub8cc \uc124\uacc4, \ub2e4\uad6d\uc5b4 \ubb38\uc11c\ud654\uac00 \ud544\uc694\ud558\uc2e0\uac00\uc694? <strong>IFU <\/strong><strong>\ucd08\uc548\ubd80\ud130 \ucd5c\uc885 FDA \uc81c\ucd9c\uae4c\uc9c0<\/strong>, Hansem Global\uacfc AWG\uac00 \ud568\uaed8\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Hansem Global\uc758 IFU \uac1c\ubc1c \ubb38\uc758: info@hansem.com&nbsp;|&nbsp;<a href=\"http:\/\/www.hansem.com\" target=\"_blank\" rel=\"noreferrer noopener\">www.hansem.com<\/a><\/li>\n\n\n\n<li>FDA\uc2b9\uc778\uc744 \uc704\ud55c \ubc95\ub960 \uc790\ubb38 \ubb38\uc758: Neil O\u2019Flaherty, Amin Wasserman Gurnani LLP \u2013 noflaherty@awglaw.com&nbsp;|&nbsp;<a href=\"http:\/\/www.awglaw.com\" target=\"_blank\" rel=\"noreferrer noopener\">www.awglaw.com<\/a><\/li>\n<\/ul>\n\n\n\n<p><\/p>\n","protected":false},"featured_media":7667,"parent":0,"menu_order":0,"template":"","blog-types":[126],"class_list":["post-7664","blog","type-blog","status-publish","has-post-thumbnail","hentry","blog-types-user-manuals-content-creation-ko"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - 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