Zimmer SonoOne User manual

SonoOne
Instructions for Use
使用說明書
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Explanation of symbols
Indended Use
符號說明
用途
SonoOne 是一款超聲波治療儀器，利用超聲波將組織加熱，以治療肌肉骨骼系統的疾病。
SonoOne
is an ultrasound therapy device for application ofultrasound in order to heat tissue for purposes of
treatment ofdiseases of the musculoskeletal system.
本使用說明書是儀器的重要部分，必須與儀器一起存放，並且應存放於獲准操作此儀器之
人士能觸及的地方。本使用說明書自2018年6月起生效。
This instruction for use is an integral part of the device. It must be stored with the device and kept accessible
at all times for anyone who is permitted to operate the device. The instructions for use are valid as of June
2018.
在使用說明書中， 此符號表示
“危險＂
In the instructions for use, this symbol
indicates “Danger”.
CAUTION-ULTRASOUND
ATTENTION-ULTRASONS
小心超聲波
Caution ultrasound
請遵從使用說明
Follow the instructions for
use
REF 商品編號
Article Number
生產日期
Date of manufacture
II 類設備
Class II equipment
儀器類型 BF
Device Type BF
SN 序號
Serial number
製造商
Manufacturer
此符號表示儀器上的危險部分
This symbol indicates danger areas on
the device.
!
Caution
警告 !在使用說明書中，此符號表示有
關儀器損壞的“警告＂
In the instructions for use, this symbol
represents “Caution“ with regard to
damage of the device.

Indications / Contraindications
適應症 / 禁忌症
為患有肌肉骨骼系統疾病 (例如肌腱病變、關節疾病) 的組織進行熱療。
Heating tissue in cases of diseases of the musculoskeletal system e.g. Epicondylopathy, Joint diseases.
適應症 · Indications
禁忌症 · Contraindications
• 有不明痛症的人士
• 不能使用熱療的疾病，例如急性炎性
疾病
• 嚴禁受機械衝擊的疾病，例如深層靜
脈血栓
• 接受血流限制的人士
• 懷疑患有心血管系統疾病的人士
• 有出血性傾向的人士
• 頸椎 (不得在高於C 3的位置使用超聲
波)
• 薄壁或對熱力較敏感的器官 (如睾丸、
眼睛、姙娠子宮、肝臟、腎臟等)
• 麻醉的皮膚區域
• 溫度感知障礙
• 接受電離輻射治療後
• 不得用於骺板
• 不得用於腫瘤
• 不得用於電子起搏器
• 不得在開放傷口或其附近使用
• 條件反射活動或痛覺敏感度減弱
• 懷孕或假定懷孕時，不得用於腹部、
骨盆或腰部區域
金屬植入物和內置假體：現時，人們不
需再擔心使用低劑量的動態超聲波會引
起問題，超聲波應用治療沒有已知的副
作用。
• Vague pain symptoms
• Diseases where heat should not be used, for
example, acute inflammatory diseases
• Diseases where mechanical impacts are
contraindicated, e.g. deep vein thrombosis
• Restricted blood flow
• Suspected diseases of the cardiovascular
system
• Haemorrhagic diathesis
• Cervical vertebrae – do not use ultrasound
higher than C 3
• Ultrasound treatment of parenchymatous or
heat-sensitive organs (testes, eyes, gravid
uterus, liver, kidneys etc.)
• Anaesthetised skin areas
• Temperature sensitivity disorders
• After treatment with ionizing radiation
• Epiphyseal plates
• Tumours
• Electronic pacemakers
• Application on or in the vicinity of open
wounds
• Impaired reflexes or pain sensitivity
• Application to the abdomen, pelvis, or
lumbar area when pregnant or presumed
pregnant
Metal implants and endoprosthesis:
Dynamic ultrasound radiation in low dosage is
nowadays no longer a matter for concern. No
side effects are known in the therapeutic
application of ultrasound.
1

Application information
使用資訊
Caution !
注意 !
為避免觸電，保養或清潔工作前，請拔除插頭，切斷電源。
To avoid the risk of electric shock, disconnect the device from the mains supply by pulling the plug before
carrying out any maintenance or cleaning work.
使用前，請確保使用有接地的插座及插頭為儀器供電 (根據DIN VDE 0100-710的電器安裝)。
必須使用附設的電源線來操作儀器，並必須保護電源線免受機械壓力。
Before use, ensure that the device is powered via a properly earthed plug with a grounded outlet (electrical
installation according to DIN VDE 0100 Part 710).
The device must only be operated with the supplied power cord. The power cord must be protected against
mechanical stress.
磁場和電場可能影響儀器的功能。因此，請勿在會產生強烈電磁場的設備 (X射線、透熱設
備或MRI掃描儀) 的附近操作本儀器。請保持幾米的安全距離。
Magnetic and electric fields can influence the function of the device. Therefore, the device must not be
operated in the vicinity of devices that generate strong electromagnetic fields (X-ray or diathermy devices,
MRI scanners). Please keep a safe distance of several metres.
本設備不適用於有易爆、易燃或助燃的環境。
The device is not suitable for use in areas with an explosive, combustible or combustion-promoting
atmosphere.
使用過程中，必須確保儀器直接連接中央供電，以便能隨時從主電源卸除連接。
During use, the device must be placed in such a way that direct access to the device‘s central power supply is
possible, so that it can be disconnected from the mains at any time.
使用特殊的SonoPlus超聲波凝膠以外的耦合劑會令超聲波頭損壞。
The use of coupling agents other than the special SonoPlus ultrasound gel can damage the ultrasound
transducer.
使用前檢查儀器及超聲波頭。如有損壞，則不得使用。超聲波的鋁頭容易刮花，請勿用尖
銳或尖形物體接觸超聲波頭。
Inspect the device and the ultrasound head before use. If damaged, it must not be used. Do not allow sharp
or pointed objects to come into contact with the ultrasound transducer since the aluminium head can be
easily scratched.
2

Application information
使用資訊
不得於本儀器的使用壽命期內，擅自更改本儀器或其系統。整套醫療系統適合在病人附近
使用。
During the service life of the device, no changes may be made to the device or medical system.
The entire medical system is suitable for use in the vicinity of the patient.
如果經常在水浴中使用超聲波頭，用家則必須採取保護措施。用家的所有浸在水中的身體
部位都必須以適當措施作保護，例如使用俗稱“充氣衣服＂的氯丁橡膠手套或乳膠棉手
套。
In the event of regular use of the ultrasound head in the water bath, the user must take protection measures.
All body parts of the user immersed in the water
must be protected by appropriate measures. Suitable protective measures are so-called “aerated clothes“.
This can be neoprene gloves or latex over cotton gloves.
只可使用Zimmer MedizinSysteme GmbH提供的配件。
Only accessories provided by Zimmer MedizinSysteme GmbH are to be used.
本儀器可能會導致附近的儀器故障或干擾其運作。 你可能需要採取相應的應對措施，例如
重新擺放或調整本儀器或加設屏障。
The device may cause malfunctions or may interfere with the operation of equipment in the vicinity. It may be
necessary to take appropriate remedial action, such as realignment, re-arrangement of the device or
installation shielding.
3

Warnings
警告
必須按照本說明書指定的設定及用途使用，否則可能會導致超聲波能量不受控制地釋放，
而造成危險。
The use of this product with settings or for applications other than those specified in the user manual may
lead to hazards resulting from the uncontrolled release of ultrasound energy.
任何有關治療位置、時間及強度的治療指引，必須遵守本說明書的指引使用。
Strictly follow the instructions in this manual for any treatment instructions regarding treatment location,
duration and intensity.
嚴禁在潮濕的環境使用，否則可能導致儀器損壞或對病人及用家構成危險。
Use in wet areas is not permitted and may in case of non-compliance lead to considerable damage and
endanger both the patient and the user.
體內有植入物或植入式電子裝置的病人，使用時請先諮詢醫護人員並接受風險評估。
In cases of patients with implants or an implanted electronic device do not conduct treatment before the risk
has been assessed and found negligible.
病人使用時不可同時連接高頻的手術器材否則可能引致灼傷。
Patients may not be connected to a high-frequency surgical device at the same time. This can lead to burns.
妥善棄置包裝材料，並確保兒童無法接觸。
Dispose of the packaging material properly. Make sure that it is not accessible to children.
使用時如有不適，請立即停止使用，並儘速求醫。
In case any discomfort occurs during use, stop using immediately and consult a doctor.
4

Display views
顯示視圖
1
2
9
8
7
6
5
4
3
13
14
15
16
17
18
19
20
17
18
10
11
12
圖1 程式介面
Fig. 1 Programme Screen
圖2 治療介面
Fig. 2 Therapy Screen
圖3 配置介面
Fig. 3 Configuration screen
圖4 參數介面
Fig. 4 Parameter screen
5

Description of the functions
功能說明
26
24
23
21
22
25
圖5 開關及連接插頭
Fig. 5 Switches and connector sockets
屏幕、顯示器、視窗及按鈕說明
Description of screens, displays, windows, buttons
注意：直接用手指在屏幕上操作所有視窗和按鈕。
Note: Activate all windows and buttons by pressing directly on the screen with your finger.
圖6 超聲波頭
Fig. 6 Ultrasound head
圖7 超聲波頭連插座
Fig. 7 Ultrasound head with holder
1程式介面 打開治療介面
Programme screen Opens the therapy screen
2配置介面 打開配置介面
Configuration screen Opens the
configuration screen
3上 / 下強度 調整強度
Up / down intensity Adjustment of intensity
4開始 / 停止 開始 / 停止治療
Start / Stop Start / Stop of therapy
5返回 返回程序畫面
Return Back to programm screen
6上 / 下時間 調整時間
Up / down time Adjustment of time
7時間顯示 顯示治療時間
Time display Displays the therapy time
8耦合值顯示 以百分比顯示耦合值
Coupling display Displays the coupling
value in percent
9頻率 調整頻率至1或3 MHz
Frequency Adjustment of frequency
to 1 or 3 MHz
10 參數顯示 顯示目前治療的參數
Parameter display Displays the parameters
of the current therapy
11 強度顯示 顯示調整後的功率
和/或強度
以W, W /cm²或
W + W /cm²為單位
(Weff, W /cm²峰值)
Intensity display Displays the adjusted
power and/or intensity
in W, W /cm² or
W + W /cm²
(Weff, W /cm² peak)
12 棒形圖 顯示調整後的強度
Bargraph Displays the adjusted
intensity
6

Description of the functions
功能說明
13 耦合 調整極限耦合值
Coupling Adjustment of the limit
coupling value
14 上/下聲量 調整訊號聲量
Up / down sound Adjustment of signal
sound
15 強度 顯示設置 (W, W /cm²
或W + W /cm²)
Intensity Setting of display (W,
W /cm² or W + W /cm²)
16 訊息 顯示軟件版本
Information Displays the software
version
17 取消 配置介面：停止並切
換回程式介面
參數：停止並切換回
治療介面
Cancel Configuration screen:
Stops the process and
switches back to program
screen.
Parameter: Stops the
process and switches
back to therapy screen.
18 OK 配置介面：儲存更改
設定並切換回治療介
面
參數：儲存更改設定
並切換回編程式介面
OK Configuration screen:
Save changes and switch
back to therapy screen.
Parameter: Save changes
and switch back to
programm screen.
19 保養 開啟保養清單
(僅適用於技術人員)
Maintenance Opens the maintenance
menue. Only for
technicans.
20 參數 調整治療參數：工作
模式、頻率、工作週期
Parameter Adjustment of the therapy
parameters: operating
mode, frequency, duty cycle
21 開/ 關 設備的開/關按鈕
On / off On/off switch of the device
22 電線連接
Connection for the cable
23 超聲波頭的連接插頭
Connecting socket for the ultrasound head
24 超聲波頭5 cm²
Ultrasound head 5 cm²
25 超耦合顯示
Coupling display
26 超聲波頭插座
Holder for ultrasound head
簡要電線安裝 / 治療說明
連接電源線與電線的連接線，插上連接超聲波頭的插頭，然後啟動儀器。
出現程式介面後，選擇程式，調整強度及治療時間，然後按“開始”。
設定治療時間結束後，治療會自行結束。
Mounting the cables / therapy instruction in brief
Connect the mains cable with the connection for the cable. Connect the ultrasound head with the connecting
socket for the ultrasound head. Switch on the device.
After the programm screen appears choose your programme, adjust intensity and the therapy time and press
“Start”.
Therapy ends when therapy time has elapsed.
7

Technical information
技術資料
電源電壓 100-240 V / 50 Hz / 60 Hz
220 V / 60赫茲
耗電功率 60 VA
防護等級 II級
應用零件 BF類型，換能器超聲波頭
操作模式 持續運作
尺寸 238 (長)x 138(寬)x 95 (高)毫米
重量 1kg
操作溫度 10°C至+ 40°C，相對濕度
30％至75％，無凝結，
在800 hPa至1060 hPa
運送/儲存 -10°C至+ 50°C，
相對濕度10％至90％
無凝結，700 hPa-1060 hPa
超聲波頭 5cm²，AER = 3.0cm²
BN≤5.0
IPX 7防水等級
可浸於水深1米達30分鐘
頻率 1 MHz和3 MHz
強度水平 0.1到3 W /cm²，每個強度
之間相差0.1 W /cm²
最大功率 持續模式下為6Weff，
脈衝模式下為9Wpeak
精準度 ±20％
超聲波種類 1.持續超聲波
2.脈衝超聲波，
脈衝頻率可調整
頻率：10 Hz, 20 Hz, 50 Hz,
100 Hz
工作週期：1:1、1:2、1:5、
1:10
可互換 超聲波頭在出廠前已校
準，可以輕鬆更換。只能
放在原廠包裝中儲存及運
送。
Mains voltage 100 - 240 V / 50 Hz / 60 Hz
220 V / 60 Hz
Power Consumption max. 60 VA
Protection class Class II
Applied Part Type BF,
Transducer ultrasound head
Operation Mode Continuous operation
Dimensions 238 (L) x 138 (W) x 95 (H) mm
Weight 1kg
Operation 10°C to +40°C, 30% to 75%
relative humidity
without condensation,
at 800 hPa - 1060 hPa
Transport/Storage -10°C to +50°C, 10% to 90%
relative humidity
without condensation,
at 700 hPa - 1060 hPa
Ultrasound head 5 cm², AER = 3.0 cm²
BN ≤ 5.0
IPX 7: protected from
immersion in water
with a depth of up to 1 m
for up to 30 min.
Frequency 1 MHz and 3MHz
Intensity levels 0.1 to 3 W/cm² at intervals of
0.1 W/cm²
Maximum Power 6 Weff in continuous mode,
9 Wpeak in pulse mode
Accuracy ± 20%
Ultrasound types 1. Continuous ultrasound
2. Pulsed ultrasound,
adjustable pulse
frequencies: 10 Hz, 20 Hz,
50 Hz, 100 Hz
Duty ratio: 1:1, 1:2 , 1:5, 1:10
Interchangeability Ultrasound heads are
calibrated ex works and
can be easily replaced.
Storage and transport in
original packaging only.
生產商保留更改技術參數的權利。
Subject to technical modifications!
8

Cleaning / Disinfection
清潔 / 消毒
保養和清潔前，必須關掉儀器的總掣，並且拔除電線。
Before starting any maintenance and cleaning measures the device must always be switched off at the main
switch and the mains cable must be disconnected.
清潔或消毒過程中，須確保沒有液體滲入儀器。不要使用噴霧劑。
Make sure that during cleaning or disinfection no liquid penetrates the device. Do not use sprays.
萬一清潔或消毒過程中，有液體滲入儀器，請立即停止使用，不要再啟動儀器，並聯絡顧
客服務人員。
If during cleaning or disinfecting liquid penetrates the device, please put the device out of service, protect it
from being used again and contact your service representative.
清潔和消毒儀器時，確保儀器標籤 (如警告、標籤、標識牌) 沒有損壞。
Make sure that when cleaning and disinfecting the labelling of the device (such as warnings, labels,
identification plate) is not damaged.
只要確保用於沒有傷口、健康的皮膚，無需過分注重儀器及應用配件的衞生。
The device and its applied part are considered as uncritical in relation to hygiene due to the use on
non-injured and healthy skin.
清潔：如發現明顯污漬，可使用市面上的無酒精塑膠清潔劑清潔外殼及所有電線。
參考生產商的指引，選擇清潔劑，將軟布浸入清潔劑，但注意不要過濕，拭擦去除污垢。
Cleaning: In the event of visible contamination, the housing and all cables can be cleaned using commercial-
ly available alcohol-free plastic cleaners. Wipe the surface until the dirt is removed, using a soft cloth soaked
according to the specifications of the manufacturer of the cleaning agent but not dripping wet.
外殼 / 超聲波頭
Housing / Ultrasound head
9

Cleaning / Disinfection
清潔 / 消毒
消毒：建議每周至少進行一次消毒，以及檢查是否有受污染跡象，詳情請諮詢衞生專家。
請先清潔表面再進行消毒。
可以使用消毒濕巾消毒外殼及所有電線。請使用市面上不含酒精，且有殺菌、消毒及殺真
菌功效的金屬及塑料消毒劑。
請遵守製造商的使用說明。
參考生產商的指引，選擇消毒劑，將軟布浸入消毒劑，但注意不要過濕，拭擦整個表面，
或使用消毒濕巾拭擦。
請遵守風乾或清潔後的要求 (如適用)。
Disinfection: We recommend that disinfection is to be carried out at least once a week, as well as if there
is any indication of contamination. Consult with your hygiene specialist when doing so. Always perform
cleaning prior to disinfection.
Housing and all cables can be disinfected using disinfectant wipes. Use a commercially available alcohol-free
disinfectant for metal and plastic, with bactericidal, virucidal and fungicidal properties.
Observe the instructions for use of the respective manufacturer.
Wipe all surfaces using a soft cloth soaked according to the specifications of the manufacturer of the
disinfectant, but not dripping, or with a cloth pre-impregnated with disinfectant (wipes).
Also observe requirements for drying or post-cleaning, where applicable.
如使用易燃溶液清潔和消毒，必須預留足夠時間供溶液揮發，否則有引起火災的危險。
If flammable solutions are used for cleaning and disinfecting, sufficient time must be allowed for the solution
to evaporate before using the device. Otherwise, it may constitute a fire hazard.
僅在衛生的環境中使用本儀器。
Use the device only in a hygienic environment.
注意
Note
10

CE mark
歐洲合格認證
本儀器持有CE標誌
符合醫療設備93/42/EEC指令。
The devices have a CE mark
in accordance with the EC directive on medical
devices 93/42/EEC.
0123 0123
11

Scope of delivery / Accessories
供貨範圍 / 配件
Combinations
組合方式
供貨範圍：SonoOne
貨號
5360 1個基本儀器SonoOne
4201 1超聲波頭1和3 MHz，5cm²
53 601 100 1超聲波頭插座
118 1條電線
6 1瓶SonoPlus
10 102 642 1使用說明
Scope of delivery: SonoOne
Art.No.
5360 1 basic device SonoOne
4201 1 ultrasound head 1 and
3 MHz, 5 cm²
53 601 100 1 holder for ultrasound head
118 1 mains cable
6 1 bottle SonoPlus
10 102 642 1 instructions for use
SonoOne不適用於與其他儀器組合。
SonoOne is not intended for combination with other devices.
12

Error Messages / Functional test / Legal Notices / Disposal
錯誤訊息 / 功能測試 / 法律聲明 / 棄置
錯誤代碼列表
224/1通訊錯誤
402/2超聲波治療頭過熱 407/2 PLL故障
406/2超聲波頭未接觸 410/2輸出電壓異常
某些情況下，重新啟動電源可解決問題。只能由專業人員維修。另提供服務手冊。
功能測試
用耦合凝膠覆蓋超聲波頭，設定強度，開始治療，耦合值必須達90 %以上。
Error Code list
224/1 Communication Error
402/2 Ultrasound applicator has overheated 407/2 PLL fault
406/2 Ultrasound head not connected 410/2 Output Voltage abnormal
In some cases switching the device on an off may solve the problem. Service and repair only by trained
staff. Service manual available.
Functional test
Cover ultrasound head with coupling gel, set intensity, start therapy. Coupling display must indicate
over 90 %.
如有疑問或設備出現故障，請聯繫分銷商。
For questions or in case of equipment malfunctions, please contact the distributor.
13

Error Messages / Functional test / Legal Notices / Disposal
錯誤訊息 / 功能測試 / 法律聲明 / 棄置
SonoOne並未有在MPBetreibV的附件1中列出。本儀器未在MPBetreibV的附件2中列出。
於德國境內使用，必須遵守DGUV法規3 (電器系統及設備) 的最新版本。
棄置時，必須將本儀器連同原廠包裝退還給Zimmer MedizinSysteme。
在國外使用 (德國以外)，請參照國家的棄置法例。如有必要，請聯絡分銷商。
SonoOne is not listed in Annex 1 of MPBetreibV. The device is not listed in Annex 2 of MPBetreibV. In
Germany, the DGUV regulation 3 (Electrical Systems and Equipment) in its current version must also be
observed.
For disposal, the device may only be returned to Zimmer MedizinSysteme in its original packaging.
In foreign countries (outside of Germany) please refer to national regulations for disposal. Contact your
distributor if necessary.
這些注意事項適用於在德國境內操作。其他國家的用家請遵守你所在國家/地區適用的法例
(如適用)。
These notes apply to the operation of the device in Germany. If applicable, observe any divergent national
regulations that apply in your country.
注意
Note
14

Manufacturer‘s EMC Declaration
製造商的EMC聲明
Guidelines and Manufacturer‘s Declaration - Electromagnetic Emissions
The SonoOne One must
ensure that it is operated in such an environment.
Emissions measurements Compliance Electromagnetic environment - guidelines
RF emissions in accordance with CISPR 11 Group 1 The SonoOnedevice uses RF energy solely for its
internal functioning. It RF emission is therefore
very low and itis unlikely that this will cause
interference to neighbouring electronic Rehab-series
RF emissions in accordance with CISPR 11 Class A The SonoOne device is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Emissions of harmonics in accordance with IEC
61000-3-2
Category A
Compliant
Table 201 according to EN 60601-1-2: 2006-10
The device must not be used in direct proximity to or stacked directly on top of another similar device. If operation near to or stacked on top of another device is
unavoidable, the device should be monitored to verify its proper operation within this setup.
Guidelines and manufacturer‘s declaration - electromagnetic immunity
The SonoOne One device should
ensure that it is used in such an environment.
Immunity tests IEC 60601 - Test Level Compliance level Electromagnetic environment - Guidelines
Electrostatic discharge (ESD) in
accordance with IEC 61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
± 6 kV contact discharge
± 8 kV air discharge
Floors should be made from wood, concrete or
material, the relative humidity mustbe at least30%.
Electrical fast transient / burst in
accordance with IEC 61000-4-4
± 2 kV for mains cables
± 1 kV for input and output
cables
± 2 kV for mains cables
Not applicable
The supply voltage quality must correspond to that
of a typical commercial or hospital environment.
Surges in accordance with IEC
6100-4-5
± 1 kVdifferential mode
± 2 kVcommon mode
± 1 kVdifferential mode
± 2 kVcommon mode
Not applicable The supply voltage quality must
correspond to that of a typical commercial or
hospital environment.
Voltage dips, short-term interruptions
and voltage variations in accordance
with
< 5% UT
(> 95% dip in UTfor ½ period)
40% UT
(60% dip in UTfor 5 periods)
70% UT
(30% dip in UTfor 25 periods)
< 5% UT
(> 95% dip in UTfor 5
seconds)
< 5% UT
(> 95% dip in UT for ½ period)
40% UT
(60% dip in UT for 5 periods)
70% UT
(30% dip in UT for 25 periods)
< 5% UT
(> 95% dip in UT for 5
seconds)
The supply voltage quality must correspond to that
of a typical commercial or hospital environment.
If the user of the SonoOne requires continued
operation, even in the case of interruptions in the
power supply, it is recommended that the SonoOne-
be powered from an uninterruptible power supply
or a battery.
(50/60 Hz) in accordance with IEC
61000-4-8
3 A/m 3 A/m
the typical values found in a business or hospital
environment.
Note: UT is the mains AC voltage before application of the test level
Medical electrical equipment such as the SonoOne are subject to special precautions with regard to EMC (electromagnetic compatibility) and must be installed
and commissioned in accordance with the EMC information contained in the user manual or the accompanying documents.
醫療電子設備例如SonoOne必須遵守有關EMC (電磁兼容性) 的特殊預防措施，並且必須根據使用說明或附設
文件中包含的EMC訊息進行安裝和調試。
Portable and mobile RF communications equipment (e.g. mobile phones) can affect electrical medical equipment.
便攜式和移動的RF通訊設備 (例如手提電話) 會影響醫療電子設備運作。
SonoOne
device with other parts may result in increased emissions or in the device‘s decreased interference immunity.
SonoOne只能配合列表中的部件及原廠包裝內附設的配件使用。如配合其他部件使用，可能會導致電磁排
放增加或降低儀器的抗干擾性。
15

Recommended separation distances between portable and mobile RF communications equipment and the SonoOne device
The SonoOne device is intended for use in an electromagnetic environment in which RF disturbances are controlled. The customer or the user of the SonoOne
device can thus help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the SoleoOne device – depending on the output power of the communications equipment as indicated below.
Rated power of the transmitter
W
Separation distance depending on the frequency of transmitter
m
150 KHz to 80 MHz
d = 1.17 √P
80–800 MHz
d = 0.35 √P
800 MHz to 2.5 GHz
d = 0.7 √P
0.01 0.12 0.04 0.07
0,1 0.37 0.11 0,22
1 1,17 0,35 0,7
10 3,70 1,11 2,21
100 11,67 3,5 7,0
determined using the equation given for the corresponding column, where P is the maximum rated power of the transmitter in watts (W) in accordance with
the manufacturer of the transmitter.
NOTE 1: At 80 and 800 MHz, the higher frequency range applies.
One device is used exceeds
the above compliance level, the SonoOne device must be monitored to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as the realignment or relocation of the SonoOne device.
Guidelines and manufacturer‘s declaration - electromagnetic immunity
The SonoOne One device should
ensure that it is used in such an environment.
Immunity tests IEC 60601 - Test Level Compliance level Electromagnetic environment - Guidelines
Conducted RF disturbance variables
in accordance with IEC 61000-4-6
Radiated RF disturbance variables in
accordance with IEC 61000-4-3
3 VRMS
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 VRMS
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
Portable and mobile RF communications equipment should not
be used any closer to the SonoOne including cables, than the
recommended separation distance calculated using the equation
relevant for the transmission frequency.
Recommended separation distance:
d = 1.17 √P
d = 0.35 √P for 80MHz to 800 MHz
d = 0.7 √P for 800 MHz to 2.5 GHz
where P is the power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the
recommended separation distance in metres (m).
In accordance with an on-site investigationa , for all frequencies,
than the coincidence levelb.
Errors may occur in the vicinity of devices marked with the
following symbol:
NOTE 1: At 80 Hz and 800 MHz, the higher frequency range applies.
Key features of the SonoOne
16

17

SonoOne
Instructions for Use
使用說明書
ZMER-00021_1
電子產品網上保養登記請到：
Online Warranty Registration for Electrical Product at：
http://www.healthcarehk.com
服務熱線 Service Hotline：[phone]
地址：香港新界葵涌工業街23-31號美聯工業大廈21樓B室
Address：Unit B, 21/F, Mai Luen Industrial Building,
23-31 Kung Yip Street, Kwai Chung, N.T., H.K.
* 如中、英文兩個版本有任何抵觸或
不相符之處，應以英文版本為準。
* If there is any inconsistency or ambiguity
between the English version and the
Chinese version, the English version shall
prevail.