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衛署醫器陸輸字第 000265 號
型號:Luminos RF Classic
產品敘述及用途:
本產品是一種 X 光系統,可作一般工作站使用,也可作為特殊工作站使用。
可施行以下檢查:
藉由影像強化器及電視系統的透視
以定點攝像(spotfilm)裝置作片匣攝影
- 定點攝像
- Bucky 攝影
- 斷層攝影
在檢查台上片匣攝影
在病床邊攝影
壁式攝影
警告及注意事項:
z 異常移動:如系統任何部件自行移動時,有可能為故障。需關閉系統並連絡西門子人員
(Siemens Service) 。
z 紅色緊急停止(STOP)按鈕:如果系統動作異常導致發生緊急狀況,而危及病人、操作者
或是系統本身,需:
立即按下任何一個紅色緊急停止(STOP)按鈕
- 系統所有的運作都會關閉且立即停止移動
- 中斷輻射、透視及影像擷取
z 系統發生故障時,按下紅色緊急停止(STOP)按鈕,然後再解除
z 緊急狀況/危險狀況發生時關閉電源:如危及病人、操作者、第三方人員或是系統本身時
按下現場的緊急關閉(SHUTDOWN)按鈕:會切斷整個系統的電源供應
z 輻射防護
- 病患:
在透視及影像擷取時,應盡可能給予病人的生殖器官作輻射防護(使用性腺屏蔽、鉛
膠保護蓋)
在不影響有效測量照野的情況下盡可能縮小照射範圍
盡可能將透視或輻射照野內的所有不透光物品移除
盡可能調高 X 光球管的電壓(需考慮影像品質)
幫病人作檢查時,在合理的範圍內應盡可能讓 X 光球管遠離病人的皮膚
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- 檢查者:
盡可能在控制室內啟動影像擷取程序
在控制區停留的時間越短越好
在控制區裡進行檢查時,應穿著防護衣物
盡可能遠離輻射源
佩帶劑量佩章或筆型輻射劑量儀以檢查個人輻射劑量
盡可能使用機械式防護屏蔽(保護上下半身)
- 緊急狀況時關閉電源:按下最近的緊急停止(STOP)按鈕
z 火災防護:使用二氧化碳滅火器。不可在可能產生爆炸性氣體的場所使用本系統。
z 本器材之使用須符合「特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法」之規定
規格:
系統
電源連接 系統經由產生器連接到電源
標稱電壓: 3/N/PE, 400V ± 10%
標稱頻率: 50/60 Hz ± 1 Hz
環境條件(操作時)
溫度 +10℃到+35℃
相對濕度 20%到 75%,無水氣凝結
氣壓 700 hPa 到 1060 hPa
裝設所需之地面空間 最少 5.15 m x 4.10 m
重量
照射台 約 1250 kg
控制台 約 2.5 kg
產生器箱 約 339 kg
所需空間之高度 最少 3.20 m;在 2.50 m 到 3.20 m 之間電腦系統將自動限制機器
的移動
照射台
照射台與病人檢查台
照射台傾斜角度: 馬達驅動,+90°到-17°;傾斜速度約 4°/s;可開啟/關閉到達水平
位置(0°)自動停止的功能
照射台高度: 89 cm
檢查台: 尺寸:外圍 210 cm x 80 cm,透光部份 193 cm x 55 cm
衰減當量:
在電壓 100 kV 半值層(HVL) 2.7 mm Al 的情況下,
衰減當量為≤ 0.6 mm Al
在電壓 100 kV 半值層(HVL) 3.7 mm Al 的情況下,
衰減當量為≤ 0.65 mm Al
病人重量: 最大可至 200 kg,並且有以下的限制:
- 181 kg 到 200 kg:病人須水平置於檢查台正中央,身體不得突
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出於檢查台之外,檢查台不得作縱向及橫向移動;
- 151 kg 到 180 kg:病人須置於檢查台正中央,移動速度最大僅
限 20%,檢查台的縱向移動限制在±40 cm,向前的橫向移動限
制在 7.5 cm;垂頭仰臥式的角度限制為 45°,並且要使用肩部
支撐墊及足部束縛帶將病人固定好。
- 0 kg 到 150 kg:檢查台的縱向及橫向移動沒有限制。施行心臟
急救(CPR)時,可在檢查台的中央位置附加 50 kg 的力量
縱向移動距離: 160 cm,馬達驅動,可往頭部及足部各移動 80 cm;速度約為 6
cm/s;傾斜角度在 50°至 90°的情況下具備自動停止的功能。
橫向移動距離: 35 cm,馬達驅動,左右各 17.5 cm;速度約為 4.5 cm/s
X 光球管組件架:
射源到影像距離(SID): 115 cm 及 150 cm,可以馬達驅動調節;調整的速度約為 4 cm/s
傾斜投影: 最大為±40°
X 光球管組件旋轉角 手動調整,在+90°至-90°的範圍內每 15°有一停止點,在-90°至
度: -180°的範圍內每 30°有一停止點
定點攝像裝置:
X 光片匣: 前置式載入片匣,格式從 18 cm x 24 cm (8”x 10”)到 35 cm x 43 cm
(14”x 17”)皆可,依據 X 光片匣的設計作分割;可自動捲入、置中
並辨識 X 光片匣格式
自動格式校準: 可依據片匣定點攝像所使用的高度/寬度格式個別來作選擇;
Bucky 攝影可自動格式化,也可在一到兩秒後進行物件相關的校
準
X 光片分割: 最多可分割成 4 份;輔助寬度光闌(secondary width diaphragms)
元件
影像強化器(I I) SIRECON 23 DQM
3 種影像視野:Φ21.5 cm;Φ17 cm;Φ13 cm
SIRECON 33 M
3 種影像視野:Φ30.3 cm;Φ21.5 cm;Φ16 cm;Φ 12 cm (需使
用附加的縮放功能)
電視攝影機 Raycam
電視標準 掃瞄頻率50 Hz:以50 Hz掃瞄時,掃瞄線數為625
掃瞄頻率60 Hz:以60 Hz掃瞄時,掃瞄線數為525
螢幕 48 cm (19”) 彩色平面螢幕 HL1916
X光產生器 POLYDOROS F55 (100 kV/55 kW)
電功率 55 kW (電壓100 kV/電功率55 kW時,電流為550 mA)
電壓 40 kV至150 kV
X光球管組件 OPTITOP 150/40/80HC-100,附有風扇
標稱電壓: 150 kV
標稱電功率: 40 kW;80 kW
標稱焦斑值 0.6;1.0
蓄熱能力(陽極) 580,000 J (783,000 HU)
總過濾 ≥ 2.5 mm AI
多葉片準直儀
最大照野 射源到影像距離為0.7 m時,最大照野為35 cm x 35 cm
射源到影像距離為1.0 m時,最大照野為43 cm x 43 cm
最小照野 射源到影像距離為1.0 m時,最小照野< 3.0 cm x 3.0 cm
旋轉角度 與中央射束軸成±45°
鹵素燈 更換時僅限使用西門子原廠鹵素燈
24V/150W/零件號碼:8375545G2107
固有濾光能力 在70 kV下為1.0 mm Al
附加濾光器 0.1mm/0.2mm/0.3mm Cu (手動式濾光器選擇)
輻射防護 依操作者所進行的調節而定,最高可達X光球管的最大電壓150
kV
全照野定位燈亮度 ≥ 160 lux (距離 1 m 測量)
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(在使用西門子原廠的3照野模板以及劑量測量腔的情況下)
尺寸 (高 x 寬 x 深) 183 mm x 232 mm x 352 mm
最大重量(不含配件) 10.5 kg 至 15.5 kg
配件的最大重量 ≤ 7 kg
連接負載 30 – 40 V AC;50/60 Hz;8A
孔徑角度 28°/28°
Vertix Swing 直立式照 具備可調整高度的往復式柵板(catapult bucky)、透明網柵以及
相 IONTOMAT 3 照野游離腔;往復式柵板為右側或左側操作。
中央射束高度 地面以上 38 cm 到 190 cm (15”到 74.8”)
柵板垂直調整的高度 152 cm (60”)
片匣裝載 左側或右側,依設定的組態而定
格式 符合下列尺寸(公分/英吋)的片匣
13 cm x 18 cm (5” x 7”) 到 35 cm x 43 cm (14” x 17”)
直式或橫式
往復式 Bucky 網柵 Pb 10/40, f0 = 110 cm 到 180 cm
Vertix Swing 系統配備往復式的網柵,能確保曝光時間> 4 ms 的情
況下得到清晰的影像
照相劑量測量 3 照野 IONTOMAT 游離腔
足板到光片距離 < 4.5 cm
總重量 約 160 kg
輻射吸收 電壓 100 kV 的情況下≤ 0.55 mm Al
系統衰減因子 1.91
操作的環境條件 環境溫度:+10℃到+35℃
相對濕度:20%到 75%
大氣壓力:700 hPa 到 1060 hPa
5
Part System Overview/Operating Elements
Introduction
Application
The Luminos RF Classic is an X-ray system for universal use. It is suitable both as
intensively used universal workstation and as a highly loaded special workstation.
You can perform examinations with the following techniques:
Fluoroscopy through image intensifier and television system
Cassette exposures with spotfilm device
– Spotfilms
– Bucky exposures
– Tomography
Tabletop cassette exposures
Bed-side exposures
Exposures onto the wall stand
Product description
Luminos RF Classic universal X-ray diagnostic unit with swiveling overtable X-ray
tube assembly, oblique projection, and tomography in all table positions and
gently starting and braking system movements.
Two-stage setting of the source-image distance.
Table tilt + 90°/-17°.
Motor-driven longitudinally and transversely moving tabletop. Fully automatic
spotfilm device with extensive segmentation program and large axial travel range.
Integrated system movement control on the spotfilm device.
Caution
Caution
Unit movements
Risk of collision
It is the responsibility of the operator to ensure that unit movements are released
only if it is certain that neither the operator, the patient, third parties nor other
pieces of equipment can be endangered by these movements.
Make sure you are standing outside the dangerous area.
Remove any objects or accessories, e.g. injector or infusion stand, from colli-
sion area.
Deadman function All unit movements are controlled with a deadman grip (DMG), that is, move-
ments are performed only while the operating element is being actuated. If there
is a danger, stop the movement immediately by releasing the operating element.
Danger of crushing The patient and operating personnel must grip only the handles which are intend-
ed for the proper handling of the equipment or positioning of the patient. Where
it is not possible, pay attention to possible risks of injury by crushing in the vicinity
of moving parts.
Pay special attention to the risks of crushing fingers/hands between moving
parts and their guide openings.
Before performing unit movements make certain that the patients do not grasp
the frame of the tabletop.
Abnormal movements If any part of the system moves without being activated, there is possibly a fault.
Shut down your system and call Siemens Service.
Canceling STOP Disengage the emergency STOP button only when you have unequivocally identi-
fied and remedied the cause of the danger.
To do so, pull the red emergency STOP button
Note
If there is a system failure:
press the emergency STOP button and unlock it again.
This will reinitialize the system.
Caution
Technical error.
Unwanted radiation released.
In case of unwanted radiation cannot be stopped by Emergency Stop, please
press the Switch off button or the next Emergency off button (if provided by
customer) to switch off the whole system.
Caution
Shutdown using the emergency SHUTDOWN button
Risk of data loss and/or
Damage to tube due to lack of cooling
Operate the emergency SHUTDOWN button only in case of emergency or if the
system cannot be switched off normally.
Note
An emergency power supply, if one is connected, is not activated when emergen-
cy SHUTDOWN is pressed.
Switching on again
Release the emergency SHUTDOWN button and operate the system again only
when you have unequivocally identified and remedied the cause of the danger.
In all other cases, for example, system malfunction, contact Siemens Customer
Service immediately.
Radiation protection
The X-ray equipment Luminos RF Classic with radiation protection complies with
IEC 60 601-1-3 : 1994.
Mode of operation: continuous
Important information
Radiation protection If possible, ensure the best possible protection of the patient during fluorosco-
for the patient py and acquisitions in the vicinity of the patient’s reproductive organs (use go-
nadal shields, lead-lined rubber covers).
Keep the radiation field as small as possible without reducing the active mea-
suring field.
Remove all radiopaque parts from the fluoroscopic or radiographic field, if pos-
sible.
Set the X-ray tube voltage as high as possible (not forgetting the image quality;
the optimum is 63 kV for iodine contrast).
Set the X-ray tube to skin distance as large as is reasonable for each examina-
tion.
Radiation protection If possible, release the acquisition series in the control room.
for the examiner
Make your stay in the control area as short as possible.
Wear protective clothing in the control area during examinations.
Maintain the maximum possible distance from the source of radiation.
Check your personal dose by wearing a radiation monitoring badge or a pen
dosimeter.
If possible, use mechanical protective shields (protection for upper and lower
body). These shields contribute greatly to your personal radiation protection.
Switching off in an If a problem, for example, a defect, occurs during the examination and you can in-
emergency terrupt radiation no longer by letting go of the radiation release button:
Fire protection
If there is a fire, shut down the entire system immediately, that is, disconnect the
system from the main power supply.
Press the emergency SHUTDOWN button or actuate the main or disconnecting
switch.
Use a CO2 fire extinguisher.
Do not use water!
Caution
Fire inside or in the vicinity of the system
Risk of injury of patient and personnel and damage to the property.
Risk of gas poisoning caused by burning plastics.
Switch off the acquisition system in the event of fire.
Make sure that you and the patient know where the escape routes are.
Make sure that you know where the fire extinguishers are located and familiar-
ize yourself with the use of them.
Explosion protection
Warning
The system is not designed for operation in explosion-endangered areas.
The systemdoes not fulfill the requirements for AP/APG classification.
Danger of explosion!
The system must not be used where explosive atmospheres can arise.
Note
AP Use only products with the AP mark (AP = anesthetics test) in explosion-
endangered areas.
All technical data represent typical values unless specific tolerances are stated.
System
Power connection The entire system is connected to the power supply via the generator
Ambient conditions
(operation)
Degree of
protection Type B
Weight
1
Pretransformer required for 480 V
Table
Table and patient ta-
bletop
Table height: 89 cm
Longitudinal travel: 160 cm motor-driven, 80 cm each to the head and foot end; speed approx. 6 cm/s;
automatic stop for centering within the tilt range of 50° to 90°
Transverse travel: 35 cm motor-driven, 17.5 cm each to the left and right; speed approx. 4.5 cm/s
Tube assembly rotation: Manually in the range of + 90° to - 90° with stops every 15° and -90° to -180° with
stops every 30°
Spotfilm device:
Cassettes: Front loading for cassettes standardized according to IEC, ANSI, and DIN (metal or
plastic) of the formats 18 cm x 24 cm ( 8” x 10”) up to 35 cm x 43 cm (14” x 17”),
segmentation according to cassette program;
drawing in, centering, and format sensing automatically
Automatic format Selectable separately according to format height/width for cassette spotfilming;
collimation: automatic formatting for Bucky exposures, object-related collimation possible
after 1 seconds to 2 seconds
Inward movement time: Park to exposure position max. 1 s (24 cm x 30-cm cassette, without lead inlay)
Tabletop-image intensi- 12 cm
fier screen distance:
Compression device Can be remotely controlled, cone radiotransparent, detachable, and replaceable
(3 shapes)
Compression force: 0 N to 155 N, movement blockage starting from 50-N compression force
SID: 115 cm
Components
Image intensifier SIRECON 23 DQM
3 image fields: ∅ 21.5 cm; ∅ 17 cm; ∅ 13 cm
SIRECON 33 M
3 image fields: ∅ 30.3 cm; ∅ 21.5 cm; ∅ 16 cm; ∅ 12 cm (additional zoom)
TV camera Raycam
Voltage 40 kV to 150 kV
Multileaf collimator
Wallstand Vertix Swing with height adjustable catapult bucky, transparent grid and IONTOMAT 3 field
chamber; catapult bucky to be used from the right or the left side.
www.siemens.com/healthcare
What’s good value in fluoroscopy?
Tangible value
Simply clever:
The table’s automatic
anti-collision protection
retracts the tabletop
during tilting
Table tilting
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Excellent all-round patient access,
even from the back of the table
Accommodates and
manages cassettes
with ease and speed
6
A real time saver:
The newly designed
intuitive and
user-friendly remote
control console
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Source of clinical images:
Agfa Healthcare NV
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Imaging Excellence
Visible value
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Investment Confidence
* Option
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With the small distance
from central beam to table
edge, extremity examinations
are very easy to perform
Projection flexibility:
Free cassette exposures,
bedside examinations, supine
examinations and Bucky wall
stand acquisitions
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