Wi-3 HAL-RAR System Operating Manual Issue 105982

English 1. Terminology & Abbreviations • • • • • • • • •

HAL - Hemorrhoidal Arteries Ligation RAR - Recto Anal Repair (tightening/mucopexy of prolapsing tissue) Flexi Probe - Short description of the two-part ultrasound detection probe and sleeve Probe - Short description of ultrasound detection probe Device - Electronic Unit (Wi-3 HAL-RAR Unit) System - Wi-3 HAL-RAR System Trilogy - Wi-3 HAL-RAR System Speaker - Bluetooth device for playing the acoustic signal from the Wi-3 HALRAR Unit Audio Receiver - Bluetooth device for playing the acoustic signal from the Wi-3 HAL-RAR Unit

2. Product description The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR), if necessary. The hemorrhoidal arteries are located using Doppler ultrasonic technology. The Wi-3 HAL-RAR Unit generates an electrical signal and can be equipped with different probes (see section 14). Product combinations and accessories). Each of these probes is equipped with an ultrasonic sensor converting the electrical signal into an ultrasonic signal. This ultrasonic signal is applied to the rectal area and reflected by solid particles in circulating arterial blood. The ultrasonic sensor receives the reflected signal and converts it into an electrical signal. This electrical signal is then transmitted to the Wi-3 HAL-RAR Unit. The Wi-3 HAL-RAR Unit amplifies and rectifies it and generates a signal that is transmitted as an acoustic output to the audio receiver via the integrated Bluetooth interface. The RAR (Recto Anal Repair) method is used to surgically treat the prolapsing hemorrhoidal tissue, that is typical for the more advanced stages of the disease. RAR involves one or more mucopexies of prolapsing mucosa, carried out after the hemorrhoidal arteries have been ligated. Product name

REF

Components

Wi-3 HAL-RAR Unit

TRI2010

Includes Wi-3 Battery Main device Cap, Wi-3 Fixation Nut, Wi-3 Battery Set.

Page 9

Description

English Wi-3 Battery Cap

TRI2020

Cap made of high temperature plastic. Includes contacts for the batteries.

Holds the batteries

Wi-3 Fixation Nut

TRI2030

Fixation ring made of high temperature plastic.

Holds the ultrasound probe

Wi-3 Battery Set

TRI2040

Two rechargeable AA Power supply for the Batteries. Wi-3 HAL-RAR Unit.

Wi-3 Arm

TRI2070

Handle made from Aluminium

Used to hold the sleeve of the ultrasound probes RAR Flexi Probe and Wi-3 Probe

Adaptor ring

TRI2080

Fixation ring made of high temperature plastic.

Used to hold the sleeve of the ultrasound probes Flexi Probe II and ART Probe.

Speaker for Trilogy TRI2110

Bluetooth enabled speaker including charging cable.

Used to output the HALDoppler signal created by the Wi-3 HAL-RAR Unit.

Adaptor for speaker

TRI2210

Mains adaptor (without connector and cable)

Provides the power supply for the Speaker for Trilogy

Connector Europe

TRI2220

Connector for mains adaptor

Connects the adaptor to the mains socket.

A.M.I. HAL Needleholder

AHN 006

Instrument made of stainless steel.

Holds the needle of the HAL-Suture during ligation and mucopexy

A.M.I. HAL Knotpusher

AHK 007

Instrument made of stainless steel.

Pushes the knot down to the artery that is to be ligated.

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English 3. Intended use The Wi-3 HAL-RAR System is intended for surgical treatment of hemorrhoidal disease via detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of the hemorrhoidal tissue prolapse if necessary. The Wi-3 HAL-RAR Unit has a limited service life, as it is programmed to be used in 50 separate applications. Indication for use (for US market only): The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.

4. Definition 4.1 Operating elements and connections Nr.

Parts

Description / function

1

Lights

Lighting of the probes

2

Ultrasonic contacts

Includes two contacts for the ultrasonic sensor of the probe

3

Memory chip contacts

Includes two contacts for the memory chip of the probe

4

“On/Off“ button

For turning the Wi-3 HAL-RAR Unit on and off

5

“Volume“ button

For setting the volume (three volume levels available)

6

“On/Off“ indicator

Displays the operating state of the Wi-3 HAL-RAR Unit

7

“Probe“ indicator

Displays potential problems (errors) with the probe

8

“Battery” indicator

Displays the charge condition of the battery

9

Battery cap (TRI2020)

Cover for the batteries

10

Battery Set (TRI2040)

2x Battery NiMH 1.2V (or alkaline batteries 1.5V)

11

Bluetooth transmitter

Transmits the Doppler signal to the Bluetooth Audio receiver

12

Probe

Detection probe

13

Wi-3 Fixation Nut (TRI2030)

Fixation ring for the detection probe Page 11

English 14

Adaptor ring (TRI2080) Fixation ring that hold the sleeve of the ultrasound probes Flexi Probe II and ART Probe

15

Probe Sleeve

Probe protection cover

16

Suture notch

For suture placement during the mucopexy – the surgeon can place there the free end of the suture during the mucopexy

17

Wi-3 Arm (TRI2070)

Reusable holder to enhance holding position for the assistance during surgery

18

Positioning notch

Fixation notch for the sleeve of RAR Flexi Probe and Wi-3 Probe

8 7 6

1 2

4

11

3

5

10 17

9

18

16

12

15

13

17

15 13 12

14

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English 4.2 Overview of Wi-3 HAL-RAR Unit‘s functions a) System check After switching on, the Wi-3 HAL-RAR System automatically performs a system check. During this, also the three indicator LEDs are checked. These flash briefly in red, green and blue. Watch this process to see if any of the LEDs are defective. b) Lighting The Wi-3 HAL-RAR Unit features 3 LEDs lighting the probe. Do not look directly into the light.

Light Emitting Diode (Risk Group 1 according IEC 62471:2006) Do not stare into the beam! c) Volume The volume of the Doppler signal at the audio receiver depends on the volume setting of the Wi-3 HAL-RAR Unit as well as on the volume setting of the applied audio receiver. It is recommended to perform the following steps to adjust the volume:

• • •

Set the volume of Wi-3 HAL-RAR Unit to maximum. Increase the volume of the audio receiver until the desired maximum volume. Now, there is the possibility to switch between the three volume settings low, medium and high directly at the Wi-3 HAL-RAR Unit without having to operate the audio receiver.

How to adjust the volume on the Wi-3 HAL-RAR Unit is further explained in the section 1.19.3. Surgical instruction. d) Counting of the applications The Wi-3 HAL-RAR Unit is limited to 50 separate applications. To count the applications, the unit has an integrated counting mechanism. The number of remaining applications is stored in the probe and in the Wi-3 HALRAR Unit. If the Wi-3 HAL-RAR Unit is switched on, and a valid probe has been detected and there is a connection to the audio receiver, the Wi-3 HAL-RAR Unit assumes that an application is being performed and therefore reduces (after a short Page 13

English waiting period) the number of remaining applications of the probe as well as of the Wi-3 HAL-RAR Unit. As the probes are programmed for only one application, this means that they already become inoperative after counting down one application. The treatment procedure can be performed with one probe from start to finish, as the Wi-3 HALRAR Unit cannot be restarted with a probe that has already been used once. For this reason, never switch off the Wi-3 HAL-RAR Unit before the procedure has been finished. For warnings and messages concerning the number of applications of the Wi-3 HAL-RAR Unit and probes, refer to the following section. e) Displaying the remaining number of applications How to check the number of remaining applications of the Wi-3 HAL-RAR Unit: 1. 2. 3. 4. 5. 6.

Switch off the Wi-3 HAL-RAR Unit. Remove the probe from the Wi-3 HAL-RAR Unit. Press the “Volume“ button. Switch on the Wi-3 HAL-RAR Unit while pressing “Volume“. Wait until the automatic indicator LED check is completed. A repeating blink sequence of the indicator LEDs (in green) follows: a. Each number of flashes of the indicator LED “Battery“ represents 1 application. b. Each number of flashes of the indicator LED “Probe“ represents 10 applications.

Example: Indicator LED “Probe“ flashes 3 times Indicator LED “Battery“ flashes 8 times = This Wi-3 HAL-RAR Unit has 38 applications remaining. If there are no LEDs flashing, it means that the Wi-3 HAL-RAR Unit has expired and cannot be used any more. In this case, use a new Wi-3 HAL-RAR Unit. f) Bluethooth General information: In order to ensure best possible sound quality, the Wi-3 HALRAR Unit, instead of providing integrated speakers, features a Bluetooth interface compatible with many conventional Bluetooth speakers, headphones or other Bluetooth devices. This way, the Doppler signal can be put out to multiple audio devices with premium quality. Please note: Page 14

English If possible, always use the same audio receiver with the same Wi-3 HAL-RAR Unit. Each Bluetooth device has a unique Bluetooth address. Therefore, two optically identical audio receivers are detected as different Bluetooth devices by the Wi-3 HAL-RAR Unit. g) Pairing of the Wi-3 HAL-RAR Unit and the audio receiver General information: Every time, a new combination of audio receiver and Wi-3 HAL-RAR Unit is used for the first time, an initial pairing becomes necessary. During this pairing procedure the Wi-3 HAL-RAR Unit and the Bluetooth audio receiver exchange information required for establishing a connection. At every successful pairing, the Wi-3 HAL-RAR Unit stores the connection details of the audio receiver in a list (subsequently referred to as receiver list). This receiver list can contain up to three audio receivers at a time. Adding a forth receiver leads to deletion of the audio receiver that has not been used for the longest time from the list (if this audio receiver is to be used again, pairing becomes necessary). Optimal conditions for Bluetooth connection: In most cases, it is enough to provide direct sight contact between the Wi-3 HAL-RAR Unit and the audio receiver. However, if this is not enough, the following applies:

• •

• •

Locate and eliminate disturbing sources as far as possible (e.g. switch off Bluetooth function of notebooks, mobile phones or other Bluetooth transmitters). Place the audio receiver that is to be connected, close to the Bluetooth transmitter of the Wi-3 HAL-RAR Unit. The Bluetooth transmitter of the Wi-3 HAL-RAR Unit is located on the bottom of the device opposite of the “Volume” button (refer to picture in section 16). Do not cover the Bluetooth transmitter of the Wi-3 HAL-RAR Unit with your hand. To prevent an accidental connection to any other receiver than the one intended for the Wi-3 HAL-RAR Unit, please ensure that no other audio receiver is near the Wi-3 HAL-RAR Unit.

Audio receiver requirements: The Wi-3 HAL-RAR Unit is compatible with many (however not all) conventional Bluetooth audio receivers (speakers, headphones or other Bluetooth receivers), with the following features:

• •

Profile: HSP or A2DP Bluetooth version: 2.1+EDR (older versions are also supported provided the password has been set to “0000” or “1234“.)

The audio receiver from A.M.I. has already been tested for use with the Wi-3 HALPage 15

English RAR Unit. However, if another (e.g. already existing) audio receiver is to be used, the following recommendations may help to make the right choice:

• • • • • • •

Only use high-quality audio receivers (preferred with A2DP profile), Bluetooth class 2 (transmission capacity max. 2.5mW), Only use audio receivers approved for use in your country, Test function and range thoroughly, Check if other devices are disturbed by the audio receiver, Place audio receiver at the largest possible distance to other switched on devices, Use an EN 60601-1 tested adaptor for audio receivers with external connection.

Please note: In the event the selected audio receiver belongs to a different medical system, check its compatibility with the product information and make sure that there is no interference. The user is responsible for safe application of the selected audio receiver. A.M.I. only guarantees proper function of the Wi-3 HAL-RAR Unit in connection with audio receivers provided by A.M.I. If in doubt, use these audio receivers.

5. Product features and Clinical benefits • • • •

The Wi-3 HAL-RAR System enables quick and precise localization of hemorrhoidal arteries by Doppler ultrasound technology. The ligation window in the probe enables manual ligation of detected arteries. The Wi-3 HAL-RAR System is battery driven and has Bluetooth technology. Enhanced visibility due to 3 white LEDs.

6. Patient group Patients that have completed the juvenile phase. Contraindications must be considered (see section 8).

7. Indications Symptomatic hemorrhoidal disease.

8. Contraindications The Wi-3 HAL-RAR System cannot be used in case of: • Benign and / or malignant changes in the recto-anal region, • Blood coagulating disorders, Page 16

English • •

Inflammation and / or infection of the recto-anal region, Other general conditions, that are not compatible with surgical procedure.

9. Patient information The surgeon performing the operation should ensure that the patient or his legal representative is correctly and comprehensively informed on the benefits and risks associated with the HAL-RAR procedure. Before the procedure, the patient or his legal representative must be informed of the following additional issues:

• • •

Specific complications/ residual risks associated with the proposed procedure, Suitability of the patient’s condition, Evidence/ level of experience of the performing surgeon with the surgical procedure.

10. Possible complications / Adverse Events Possible complications/ adverse events may include, but are not limited to:

• • • • • • • • •

Pain (transient) Bleeding (transient) Perianal thrombosis Hematoma Pruritus ani Constipation (transient) Urinary retention (transient) Hemorrhoidal prolapse recurrence Tenesmus

11. Safety related information Danger

Warning

Caution

The keyword „danger“ indicates a hazard with a potentially high risk, which if the hazard is not avoided, the consequences are severe injuries or death The keyword „warning“ indicates a hazard with a medium risk, which if the hazard is not avoided, the consequences are severe injuries The keyword „caution“ indicates a hazard with a low risk, which if the hazard is not avoided, the consequences are minor or moderate injuries Page 17

English Note

The keyword „note“ indicates a safety information which shows a condition which has to be complied, information for understanding, as well as tips and recommendations for the effective use of the product

User group/ user qualifications: The products are intended for use by qualified and expert medical specialists. An understanding of the principles of the appropriate surgical techniques is a prerequisite. A.M.I. GmbH offers workshops wherein the usage and handling of the product in question is shown. Please contact the local distributor or the manufacturer to get the details/ information about the workshops.

12. Warnings and precautions Warning

Warning Warning Warning

Warning

Persons with cardiac pacemaker have to keep appropriate distance from the magnet of the battery cap. The information in the current Instructions for use, as well as the information accompanying the products used in combination, must be adhered to. The instructions for use at hand has to be stored to be available for the entire lifetime of the product. The Wi-3 HAL-RAR Unit (including Wi-3 Battery Cap and Wi-3 Fixation Nut but excluding the Wi-3 Battery Set), Wi-3 Arm, Adaptor Ring, HAL Needleholder, A.M.I. HAL Knotpusher, and Disposable Knotpusher must exclusively be used in sterilized state. The Wi-3 HAL-RAR Unit (including Wi-3 Battery Cap and Wi-3 Fixation Nut but excluding the Wi-3 Battery Set), Wi-3 Arm, Adaptor Ring, HAL Needleholder and A.M.I. HAL Knotpusher have to be reprocessed prior to each clinical application.

Warning

The product must not be used for any purposes other than the purpose mentioned above.

Warning

Do not attempt to alter this product in any way. Doing so may endanger the patient, user and / or third parties.

Warning

The use of damaged products or products which do not function perfectly is to be avoided. Page 18

English Warning

Warning

Warning Warning Warning Warning Warning Warning

All surgical instruments are subjected to wear and tear due to normal use. Before use, the instruments should be visually inspected. Defective instruments are not to be used but to be disposed of. Do not resterilize or reuse products that are intended for single use.

Do not use the product after the expiry date. Check sterile barrier packaging for integrity. Do not use products from open or defective sterile barrier packaging. To be used by medical professionals only! The patient should be advised that in case of any post-operative symptoms they should consult a surgeon immediately! After application, this product imposes a biological risk. Handle this product according to the provisions of the institute or applicable laws (disposal). The system may only be used in combination with products and components approved by A.M.I. (see chapter 14 and 2). Use of other accessories could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

Warning

The probe with the ultrasonic sensor must only be used for transanal application.

Warning

Avoid placing the needle too deep into the rectum tissue as this could add mayor injury to the rectum and nearby structures.

Warning

Warning

The audio receiver has to be positioned outside the patient environment because the product has not been designed as a medical device. The audio receiver, however, meets all safety standards applicable for speakers. Sterilisation of the Wi-3 HAL-RAR Unit using an autoclave is obligatory. Otherwise, water might remain in the device damaging the device or the sterile barrier packaging. Page 19

English Warning Warning Warning

Warning

Warning

Warning

Warning

If you use a slightly different sterilization cycle than described in chapter “Cleaning and Sterilisation”, ensure that the sterilization cycle is able to remove all water from the device. Do not use the device if you notice any residues on the outside of the device. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Wi-3 HALRAR System including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.” Humidity remaining from the reprocessing may impair the function of the Wi-3 HAL-RAR Unit. If the function of the device is not fully restored after consideration of the chapter 2.19 Troubleshooting the Wi-3 HAL-RAR Unit is no longer suitable for clinical use. Before every application of the system, ensure that it is complete and fully operational. Keep replacement probes and a replacement device at hand in case of unpredicted breakdown (e.g. due to damage or expiry of the service life). The Wi-3 HAL-RAR Unit processes the smallest signals of the ultrasonic sensor. Check for electrostatic discharge, fast transient bursts at the power inlet of the speaker as well as influences of electromagnetic disturbance sources (e.g. other devices or mobile phones) and remove if possible. Introduce the probe into the rectum smoothly and under low pressure to the tissue in order to avoid any damage to the tissue (especially on young patients with narrow rectum).

Warning

The Wi-3 HAL-RAR Unit features 3 LEDs lighting the probe. Do not look directly into the light.

Warning

Ensure that ligation is carried out in a pain-free part (proximal of the Linea Dentata) of the rectum.

Warning

Note

If you want to turn back the probe because you released too much tissue for mucopexy be very careful not to clamp tissue between probe and sleeve as this could damage the tissue. The battery cap contains a magnet. Do not hold the battery cap close to magnetic data storage media (credit cards…), sensitive electronic devices (hearing aids…) and other sensitive devices (watches...) or metal parts. Page 20

English Note

Note

For the TRI2010 / TRI2020 / TRI2030 and TRI2070 the number of applications is limited to a maximum of 50 cycles. Reduced number of applications is usually determined by the amount of wear and tear, and damage of the device caused by its use. Exclusively use new or freshly recharged batteries for the Wi-3 HAL-RAR Unit. Battery change during application requires a restart of the device. This is no longer possible if the probe has expired.

Note

Do not apply force onto the battery cap during application, as the battery compartment might open.

Note

To clean the Wi-3 HAL-RAR Unit do not immerse the device and do not use ultrasound.

Note

After the Wi-3 HAL-RAR Unit has detected a valid probe and a connection has been established to the audio receiver, the application time of the probe starts to run off (refer to section 1.6.2 d). To prevent the probe from becoming invalid too early do not remove the probe and do not switch off the Wi-3 HAL-RAR Unit before the treatment has been completed.

Note

Always apply ultrasonic gel. Other creams or baby oils are not suitable.

Note

Do not push the stopper of the adaptor ring too firmly. Otherwise the adaptor ring might separate from the Wi-3 Fixation Nut.

13. Information regarding the electromagnetic compatibility 13.1 Notes on electromagnetic compatibility The Wi-3 HAL-RAR System includes medical electrical devices that are subject to special precautions regarding electromagnetic compatibility (EMC). Wireless systems and other high frequency (HF) communication equipment may influence the function of the system. The combination of products that are not part of the system with the Wi-3 HAL-RAR Unit can lead to increased emissions and reduced interference immunity and can impair general security. • Do not use the Wi-3 HAL-RAR System adjacent to other electronic devices. Always keep the largest possible distance. If an operation close to other devices is necessary, the system must be monitored to ensure proper function. • Only use undamaged products. • Check if other devices show abnormal function when being used at the same time as the Wi-3 HAL-RAR System. Page 21

English 13.2 Guidance and manufacturer’s declaration - electromagnetic emissions The Wi-3 HAL-RAR System is intended for use in the electromagnetic environment as specified below. The user of the system should assure that it is used in such an environment. Emissions test

RF emissions acc. to CISPR 11

Compliance

Electromagnetic environment - guidance

Group 1

The Wi-3 HAL-RAR System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B

The Wi-3 HAL-RAR System is suitable for use in all establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

13.3 Guidance and manufacturer’s declaration - electromagnetic immunity The Wi-3 HAL-RAR System is intended for use in the electromagnetic environment as specified below. The user of the Wi-3 HAL-RAR System should assure that it is used in such an environment. The Wi-3 HAL-RAR Unit does not have any essential performance characteristics according to IEC 60601-1. The device can be disturbed by other devices even if these devices comply with the emission requirements according to CISPR.

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English 13.3.1 Enclosure Port Phenomenon

Basic EMC standard or test method

Immunity test levels (Professional healthcare facility environment

Electrostatic discharge

IEC 61000-4-2 ±8KV contact ±2kV, ±4kV, ±8kV, ±15kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Radiated RF EM fields a)

IEC 61000-4-3 3 V/m f) 80 MHz – 2,7GHz b) 80 % AM at 1kHz c

Check environment for disturbing sources and remove them if possible.

Proximity fields IEC 61000-4-3 See chapter 0 from RF wireless communications equipment

RATED power frequency magnetic fields d) e)

Electromagnetic environment - guidance

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Wi-3 HALRAR System. Otherwise, degradation of the performance of this equipment could result.

IEC 61000-4-8 30 A/m g) Check environment for 50 Hz or 60 Hz sources of Power frequency magnetic fields and keep sufficient distance to them if possible.

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English a) The interface between the PATIENT physiological signal simulation, if used, and the ME EQUIPMENT or ME SYSTEM shall be located within 0,1 m of the vertical plane of the uniform field area in one orientation of the ME EQUIPMENT or ME SYSTEM. b) ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception. Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver might not achieve normal reception during the test. c) The interface between the PATIENT physiological signal simulation, if used, and the ME EQUIPMENT or ME SYSTEM shall be located within 0,1 m of the vertical plane of the uniform field area in one orientation of the ME EQUIPMENT or ME SYSTEM. d) Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry. e) During the test, the ME EQUIPMENT or ME SYSTEM may be powered at any NOMINAL input voltage, but with the same frequency as the test signal (see Table 1). f)Before modulation is applied. g)This test level assumes a minimum distance between the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic field of at least 15 cm. If the RISK ANALYSIS shows that the ME EQUIPMENT or ME SYSTEM will be used closer than 15 cm to sources of power frequency magnetic field, the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance. Note: Expressions in capital letters are definitions according IEC60601-1.

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English 13.3.2 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band a) Frequency (MHz)

Service a)

385

TETRA 400 Pulse modulation

380-390

Modulation b)

Maximum power (W)

Ditance (m)

Immunity Test Level (V/m)

1,8

0,3

27

b)

18 Hz 450

430-470

GMRS 460, FM c) FRS 460 ±5 kHz deviation 1 kHz sine

2

0,3

28

710

704-787

LTE Band 13, 17

0,2

0,3

9

745 780 810

800-960

GSM Pulse 800/900, modulation b) TETRA 800, iDEN 18 Hz 820, CDMA 850, LTE Band 5

2

0,3

28

17001990

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

2

0,3

28

930

1845 1970

b)

217 Hz

870

1720

Pulse modulation

Pulse modulation

b)

217 Hz

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English 2450

24002570

Bluetooth, Pulse WLAN, modulation b) 802.11 b/g/n, 217 Hz RFID 2450, LTE Band 7

2

0,3

28

5240

51005800

WLAN 802.11 a/n

0,2

0,3

9

5500 5785

Pulse modulation

b)

217 Hz

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. 13.4 Information regarding acoustic output During application, the ultrasonic sensor heats up by 1.1 K. If the ultrasonic sensor is resting in stationary air (no contact to the tissue), the temperature rise is 5.9 K [1]. [1] Temperature difference in K (Kelvin) to ambient temperature. Acoustic Output - table according to IEC 60601-2-37: TIS Index Label

MI

Maximum index value

0.06

Index component value

nonscanning

At surface

TIB

At Below Below surface surface surface

0.17 0.17

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0.73 0.13

0.46

TIC 0.46

0.73

0.43

English

Accoustic Parameters

Operating Control Conditions

pr,α at zMI

[MPa]

0.17

P

[mW]

4.37 4.37

P1x1

[mW]

zs

[cm]

zb

[cm]

zMI

[cm]

0.65

zpii,a

[cm]

0.65

fawf

[MHz]

8.2

Prr

[Hz]

64000

Srr

[Hz]

--

npps

(-)

--

Ipa,α @ zpii,α

[W/cm2]

0.92

Ispta,α @ zpii,α or zsii,α

[mW/ cm2]

456

Ispta @ zpii or zsii

[mW/ cm2]

658

pr at zpii

[MPa]

0.2

Control 1

4.37

4.37

4.37

4.37

0.45 0.5

8.2

8.2

8.2

Default setting, there are no means to change acoustic output by user

Control 2 Control 3 Control 4

Correct application of ultrasonic equipment According to IEC 60601-2-37, the indices MI, TIS and TIB have been measured (refer to table above). MI (mechanical index) refers to mechanical loads (e.g. cavitation) on tissue by ultra sound. TIS (soft tissue thermal index) and TIB (bone thermal index) refer to ultra sound caused temperature increase on the tissue. Indices MI and TIS that are particularly relevant for hemorrhoidal treatment with the Wi-3 HAL-RAR Unit are very low. TIB is slightly higher (0.73). However, it is only relevant when bones are near the ultrasonic sensor. This is not to be expected during hemorrhoidal treatment using the Wi-3 HAL-RAR Unit. Even though the measured indices MI and TIS are quite low, reasonable application Page 27