HAL-Doppler II System Ultrasound Proctoscope Instruction for Use

1.

Principles of function

This device is designed for the identification of arteries. Ultrasonic waves are sent into the body by the transducer of the HAL–Probe. These waves reflect on the solid particles of the moving blood inside the arteries. The reflected waves are received by the HAL Probe sensor and converted into an electrical signal. This signal is amplified and processed in the electronic unit, before it is sent to the unit loudspeaker of or headphone.

2.

Proposed clinical applications

Please use this device for the following clinical applications only! − Diagnosis before and after hemorrhoidal artery ligation. − Diagnosis before and after sclerotherapy of hemorrhoidal arteries. − Diagnosis before and after rubber band ligation of hemorrhoidal nodulas.

3.

Features − The HAL Doppler II Device allows precise and fast identification of hemorrhoidal arteries, by means of Ultrasound Doppler technology. − The Ligation Window of the HAL Probe enables manual ligation of identified arteries. The ligation occurs within a pain free region of the rectum. − The HAL Probe design allows an easy pain free insertion into the rectum. − The HAL Handle (including cable and plug) is easy to clean and is steam sterilisation approved. − The device approximately shows the depth of the artery and the velocity of the blood flow. This should make it easier for the surgeon to identify the artery. − The position of the ligatures to be made can be fed into the system (The depth of the artery is automatically recognised by the device) in a fast and simple way and then can be printed via the integrated printer. This is to document the ligatures which were made during the HAL procedure.

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4.

Illustration

4.1. HAL II Electronic Unit 1. Front panel 2. Display 3. Key field 4. Plug Headset 5. Plug Proctoscope 6. Green lamp 7. Orange lamp 8. Power Supply 9. Battery case 10. Printer

Contains control elements of the HAL II Electronic Unit LCD-Display Used to enter in ligatures the use of a headset automatically turns off the loudspeaker. to connect the HAL Proctoscope with the HAL II Electronic Unit. indicates if device is connected to mains indicates if batteries are charged Power Supply via the A.M.I. 12V-Adaptor. Contains the rechargeable battery pack (see point 10 on page 13) Used to print out the ligatures

10 1 2 3 4 5 6 7

8

9

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4.2. HAL Proctoscope 1. Ultrasound Transducer / Sensor 2. Artery Ligation Window 3. Ligation Guide for HAL Needleholder 4. Illuminated Proctoscope Tube 5. ON / OFF Loudspeaker 6. HAL Probe Fixation Nut 7. HAL Probe 8. HAL Handle

4.2.1. Note: The above illustration shows the HAL Handle with an attached HAL Probe. It’s also possible to connect a RAR Probe and a RAR Sleeve (see point 16 on page 17) to the Handle in order to perform a mucopexie. These components will be described in the instruction manual included with every RAR Handle.

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5.

How to use

Before using this device please read the safety precautions (see point 8 on page 11). 1. Connect the Proctoscope and the Adaptor to the Electronic Unit and connect the Adaptor to the net (max. 230 V). Battery driven operation is also possible (see point 10 on page 13). 2. Check if the HAL Probe is seated and fixed properly to the HAL Handle. This is done by turning the Probe Fixation Nut again. The fixation of the HAL Probe to the HAL Handle must be firm, to secure adequate function of the device during the procedure. 3. Ensure that there is enough paper in the printer. 4. Push the “POWER ON” button on the Electronic Unit, to turn on the system. 5. Watch the automatic device control and the status report shown on the display. In case of problems follow the instructions (see point 12 on page 15) 6. Next push the “INFO” button, which allows you to choose the required language, and/or to obtain various other relevant information provided by the system. Note: If the display shows an error on the HAL Proctoscope you can enter the information menu by pressing INFO for at least 2 seconds. 7. Procedure Time Measuring starts immediately after pushing the “START/FINISH” button. For all functions provided by the system please see point 6 on page 6. 8. Put sufficient ultrasound contact gel onto the anal region and on the outside of the HAL Probe, and then insert the HAL Probe fully into the rectum. The Ligation Window should be positioned 2 to 4 cm proximal to the linea dentate. 9. Apply minimal lateral pressure and start to turn the HAL Probe carefully and slowly until the typical audible Doppler Sound has reached its peak level, indicating the presence of an artery running beneath the Ligation Window of the HAL Probe. 10. Press one of the twelve fields of the key field according to the position of the found artery. 11. Once an artery is properly identified, manual ligation is carried out through the Ligation Window of the probe. 12. In this way you can carry out all other necessary ligatures. 13. When the procedure has been completed, push the button “START-FINISH" again and print out the ligatures (see point 6.2.3 on page 8) 14. If you used a RAR Probe (see point 16 on page 17) then you can now perform a mucopexie. For more Information please read the instruction manual which is enclosed to every RAR Upgrade Kit.

Rectum

Ligation Window

Hemorrhoidal Artery

Ultrasound Sensor

Hemorrhoidal Node

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6.

Overview of all Functions

6.1. Functions available inside the OP-Modus In order to enter operation mode, plug a fully functional HAL Proctoscope (HAL Handle + HAL Probe) into the socket of the HAL II Electronic unit. Turn the device on and enter the operation mode by pushing START-FINISH. The depth display is shown first. Use MODE to switch between depth display and velocity display. 6.1.1.

Depth display:

The approximate depth of the artery is shown as the highest bars on the bar diagram. Functions: START-FINISH MODE: INFO: “+“ and “- “ Keys 1-12: 6.1.2.

Exits the operation menu Switches to the velocity display and back Switches to the list of ligatures and back Adjusts the volume of the HAL Doppler signal. Used for recording the ligatures (see point 6.1.3 on page 7)

Velocity display:

This display shows the approximate velocity of the blood flow in the artery. Functions: START-FINISH MODE: INFO: “+“ and “- “ Keys 1-12:

Exits the operation menu Switches to the depth display and back Switches to the list of ligatures and back Adjusts the volume of the HAL Doppler signal. Used for recording the ligatures (see point 6.1.3 on page 7)

In order to get a meaningful depth- and velocity display the HAL Doppler Signal must be clearly audible. Depth display and Velocity display only show reference values and should make it easier for the surgeon to find the arteries. Both displays can not be used for measuring purposes.

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6.1.3.

Recording of Ligatures:

In order to display and to hide the list of the ligatures press INFO. To record the positions of an artery: 1. 2. 3. 4. 5.

Enter the Operation Mode Seek the artery until you get an clearly audible signal Wait until there is no significant change in the depth display Press the button on the “clock” which best indicates the position of the artery. Ligate the artery

When the device recognizes the depth of the artery then this depth will be filled in into the list of ligatures and you can hear a short beep. If the device cannot recognize the depth of the artery then “N” is filled into the list and two long beeps are sounded. In order to delete a value press the according key for a duration of minimum 2 seconds. Then the last ligature which was stored at this position will be deleted and one long beep will sound. It is possible to store up to three ligatures per position. If you try to store more than three ligatures you will hear three short beeps and the input will be ignored. 6.1.4. Adjustment of volume of the HAL Doppler signal: In the operation mode the keys “+” and “-“ are used to change the volume of the HAL Doppler signal. The value is shown on the display (0-10). A value of about 2-3 is recommended. 6.1.5. Counter of the remaining applications: HAL Probes can get damaged when they are used to often. To avoid this, the number of remaining applications is counted. Whenever you use the OP-Mode, the electronic unit assumes that you are performing a surgery and therefore reduces the number of remaining applications (which is stored in the HAL Probe). When the HAL Probe is finished use a new HAL Probe.

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6.2.

Functions available outside the OP-Modus

6.2.1. Information menu: See point 7.4 on page 10. 6.2.2. Adjusting the volume of the buttons tones: In main menu and in info screen 3 (see menu guidance on page 9) the button volume can be adjusted with “+” and “-“ 6.2.3. Display and printing ligated arteries positions: Number and position of the ligated arteries can be displayed clearly with the following print out:

12

Patient Name:

DATE: START: STOP: DURATION: TOTAL: 1: 2: 3: 4: 5: 6: 7: 8: 9: 10: 11: 12:

15.Aug.2005 08:27 08:56 00:29 8

4mm N

3

9 5mm 5mm

N

N 7mm

3mm 6mm N 6

The depth displayed in the diagram ranges from 2mm (inner circle) to 10mm (outer circle). Values greater than 10mm are not shown in the diagram but can be seen on the table. Ligatures where the depth cannot be recognised are marked with “N”. If two or more ligatures occur at the same position and the depth is not detected then a number (instead of “N”) shows these ligatures in the diagram. For recording ligatures please see point 6.1.3 on page 7. In order to print out this diagram do the following: 1. Ensure that there is enough paper in the printer 2. Change to info screen 1 or info screen 2 (see menu guidance on page 9) 3. Press MODE/PRINT (in order to create an empty print out which can be filled in manually press MODE/PRINT for at minimum two seconds)

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Menu guidance Power ON

Check 1

Check HALElectronic Unit

Error message 1

A

Hardware error HALElectronic Unit

Check 2

OFF

Check HAL-Printer

System shut down

Error message 2

E

A

Error HAL-Printer S/F

Check 3

OFF

Check HAL-Proctoscope

System shut down

Error message 3

A

Hardware error HAL-Proctoscope Check HAL-Probe

System shut down

A

Hauptmenü Show the remaining applications of the inserted HAL-Probe

I

Info menü

Help on trouble shooting

Main screen

Error Message 3

S/F

OFF

+/Adjust volum e of Bee p (0-1 0)

OFF

System shut down

S ystem s hut down

HAL-Probe used up

Check 4

OFF

Info me nu

Error message 4

A

I Short press: Help on trouble s hooting Long pre ss: Inform ation menu

A

OP Modus 1 Depth power

S/F

OP Info

S/F

OFF

I

A

I

System shut down

Information about previous operation

Connection between Proctoscope and Probe

S/F

M

I

OFF

Print

System shut down

Info message 2 List of ligatures

S/F

M

I

OFF System shut down

Info message 3 Settings

S/F

I

OFF System shut down

Info message 4 Number of all Operations

S/F

I

OFF System shut down

A

I

OP Modus 2 Doppler wave

S/F

A

I

+/-

I

+/-

System shut down

Help message 3 Try fresh HAL-Probe

A

I

OFF System shut down

Help message 4 Tighten the union nut.

A

I

Legend

OFF System shut down

A

I

ON “ON” OFF “OFF” S/F “START-FINISH”

M “MODE/PRINT” I “INFO” +/- Adjust Volume A Go ahead automatically E Program detects an error

OFF System shut down

OFF System shut down

Contact us

I

I

Adjust volume of HAL-Doppler Signal (0-10)

Info message 7

S/F

M

OFF

Set date and time

I

S/F

List of ligatures

Info message 6

S/F

+/-

Clean the contacts

Call customer service

System shut down

+/-

System shut down

Select language

OFF

I

OP Info

OFF

Help message 5

I

I

Help message 2

Info message 5

S/F

S/F

System shut down

Help message 1

M

List of ligatures

OFF

Info message 1 As soon as the error is solved the HAL-II electronic unit is ready f or operation again.

7.

OFF System shut down

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7.1. General After the device is turned on it self tests the hardware including the attached Handle and Probe. In case of an error the device shows possibilities for error correction on the screen. If there is no error then main menu will be displayed.

7.2. Main menu In main menu the operation modus can be started using START-FINISH in order to localize hemorrhoidal arteries by means von ultrasonic power (see point 6.1 on page 6). With INFO the info menu can be displayed where you can view, change and print information and settings. With the buttons „+“ and „-„ the volume of the buttons can be adjusted.

7.3. Help with trouble shooting The device automatically recognises contact problems between HAL Handle and HAL Probe. Helpful information to solve this problem can be read by pushing the INFO button. If other problems occur then try to solve these problems with the help of the check list on page 15.

7.4. Information menu Use MODE/PRINT to select Items and „+“ and „-„ to change them. All changes will be stored when START-FINISH is pressed.

Info screen 1: Info screen 2:

Displays Begin, End and Duration of the last operation (print with MODE/PRINT) Displays the recorded ligatures of the last operation (print with MODE/PRINT)

Info screen 3: − Activate/Deactivate the automatic print out after each operation − Adjustment button tone volume. − Display duration of the list of ligatures after each ligation. − Setting which determines how precise the depth display must be in order to be recorded in the list of ligatures. Info screen 4: Info screen 5: Info screen 6: Info screen 7:

Show the number of all operations which were made with this electronic unit. Adjustment of the language Adjustment of date and time Show the installed software version

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8.

Precautions

8.1. General The HAL Proctoscope, HAL Probe, HAL Needleholder and HAL Knotpusher must be sterilised, prior to use! Please take note of the Non-Conformability with expandables / accessories / devices of other manufacturers! Please only use designated Storage Batteries, HAL Knotpusher, HAL Needleholder, HAL Sutures (see point 16 on page 17) and ultrasonic gel! Do not use these accessories with other devices! The unit should be only operated by experienced surgeons, who are familiar with this kind of procedure and trained in the use of the HAL Device. Before starting the operation check all the equipment (HAL II Electronic Unit, HAL Handle, HAL Probe) for damage or wear and tear (cracks in the HAL Probe) and replace the components if necessary. The HAL Proctoscope is for transanale use only. The HAL Probe transducer is a very sensitive part and requires cautious handling. Please take care not to drop or hit hard surfaces with the HAL Probe.

8.2. While operating the unit Please ensure that the plug of the HAL Handle is dry before you plug it into the socket of the electronic unit. Only an absolutely dry plug may be connected with the electronic unit! Please use always an ultrasonic gel (i.e. Xylocaine™) for coupling. Using other materials such as baby oil or cream may damage the probe. The HAL Probe should be applied gently and with minimal lateral pressure to the targeted tissue of the rectum wall. Please do not use this device continuously for more than 1 hour on the same patient, in order to avoid tissue-irritations. The electronic unit shows the number of remaining applications for each HAL Probe. After the probe has been used up properly please dispose the HAL Probe.

Do not use the HAL II Unit with any other electro surgery units or defibrillators. Make sure to disconnect the HAL Proctoscope and all cables before using the other devices. Neglecting this may burn the patient. The disconnection is only complete if the adaptor is also removed from the electronic unit. After use turn off the power and disconnect all cables. Clean the whole system and all accessories. See instructions for cleaning and sterilisation on page 13)

8.3. If the unit experiences disturbances or does not work anymore This unit is a very sensitive technical appliance which evaluates very low signals from the ultrasound transducer. Electrostatic discharge onto the device, fast transient voltage peaks (Burst) from the power input as well as electromagnetic fields can lead to sound and display interferences. If you detect such phenomena (pops in the sound or a display which changes all the time) then please check if there are sources of interference (such as other appliances or mobile phones) near to this device and remove them as far as possible. The checklist (see 12.2 on page 15) shows the failures which most often crop up and proposals for their solution. If this situation can not be sufficiently improved or if the device does not work anymore then please call your local dealer for repair / service! Do not repair the unit yourself!

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8.4. Maintenance and inspection An inspection of the unit is required at annually and must cover the following points: − Careful inspection of the HAL Handle for tears, cracks and pollution. − Inspect all cables and plugs for tears, cuts and / or other damages. − Check the HAL II Electronic Unit for any unknown sounds. This is done by shaking the Unit VERY softly and carefully as this will allow you to hear if any components have loosed. Further by starting the unit and choosing the OP-Mode, possible unknown sounds can be detected. − When using the unit after a long break, do not forget to check weather the unit operates normally and safely. − The batteries must be replaced every three years. Only use the original rechargeable battery pack from A.M.I. − Check of battery lifespan. Completely charge the batteries and then run the device in operation mode on a sound level 3. New batteries ensure an operating duration of at least 60 Minutes. We recommend batteries replacement if they are older than 3 years or if they are not able to power the device for at least 30 Minutes.

8.5. Transportation and Storage Conditions The unit may not be exposed to environmental conditions during transportation and storage, exceeding the following limits: Temperature: -20°C ... +60°C Relative humidity: 10 % ... 75 % Air pressure: 500hPa ... 1060hPa (0,5 – 1,06 bar) The following limits must be kept, during the operation of the unit: Temperature: +10°C ... +40°C Relative humidity: 30 % ... 75 % Air pressure: 700hPa ... 1060hPa (0,7 – 1,06 bar) Avoid shaking the unit during transportation and ensure dry storage. Do not place the unit near water or any other liquid. Do not place the unit in sunlight, dust, salt etc. these will affect the device adversely.

8.6. Waste disposal Please make sure that the various parts of the unit, like: − packaging − housing − electronic circuits and − batteries are (in case of disposal of unit) disposed accordingly to the applicable law of your country. In order to ensure correct disposal the device can be sent back to A.M.I. Then A.M.I. will dispose of the device professionally. The expenses will be charged.

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9.

Cleaning and sterilisation

9.1. General: Before initial use and immediately after every use all multiple use components must be disinfected and thoroughly cleaned and some must be sterilised, otherwise particles can stick to components making it difficult to clean and sterilise the components later. The Probe Fixation Nut and HAL probe must be separated from the HAL Handle prior to cleaning.

9.2. HAL II Electronic Unit and HAL II Adaptor: To clean the outer parts of the HAL II Electronic Unit and the HAL II Adaptor, please use a damp cloth and then wipe with a soft dry cloth.

9.3. All other multiple use components: The following deals with the HAL Handle, all HAL Probes (except HAL Probe Single use), HAL Knotpusher and HAL Needleholder. To remove all debris clean the various parts in a usual manner (soft brush, soft sponge) and then use a washing machine (max. 95°C), using a standard cycle for surgical instruments. Please use detergents intended only for medical instruments (i.e. Mediclean, Mediklar etc...) Do not use corrosive detergents! We recommend enzymatic and neutral detergents with ph-value 7. Only use soft brushes, otherwise the components could get damaged. Take note of the additional information provided with some of the components. It is recommended to sterilise these components in an autoclave (134°C for 5 min.). Do not sterilise with hot air. Sterilisation using steam, gas or plasma is permitted. Any cycle is applicable. ATTENTION: max. Temperature exposure of 140°C may not be exceeded! Prior to sterile packing all components (especially the plug of the HAL Handle) have to be absolutely dry.

10. Battery operation, charging and replacing of the rechargeable Batteries 10.1. Battery operation You can also operate the unit using the built-in rechargeable batteries. Fully charged batteries allow the unit to be operated for at least 60 minutes. If the device is powered by batteries and not in the operation mode and there was no key pushed for 10 seconds the backlight of the display will be automatically shut off. The electronic unit automatically switches off if it is not used for 5 minutes (only when powered by the batteries). Before initial use the batteries must be charged.

10.2. Charging the batteries The rechargeable battery pack charges automatically as soon as the electronic unit is connected to the mains via the Adaptor. When charging an orange LED "Battery Recharge" shines. As soon as the rechargeable battery pack is fully charged, charging will stop. In order to accelerate the charging process and to ensure that the batteries are completely charged, we recommended you switch off the device during charging. 10.3. Replacing the batteries Please replace the battery pack at least every 3 years. Only use the original battery pack provided by A.M.I. The batteries are replaced as follows: 1. 2. 3. 4. 5.

Remove the adapter from the electronic unit. Remove all four screws of the cover of the battery case. Remove the cover of the battery case and pull out the battery pack. Replace the battery pack and push it back into the battery case. Mount the cover again and tighten all four screws. page 13

6. Please handle the used battery pack properly! (see point 8.6 on page 12) 1

2

3

4

5

6

11. Changing the printer paper roll Only use thermal paper with following properties: Width of reel: Length of reel: Inside diameter: Outside diameter:

58mm 25m 12mm max. 48mm

In order to insert a new paper roll do the following: 1. Press the printer’s black button 2. Open the cover 3. Take out the empty paper roll and insert the axis into the new roll. 4. Pull down the end of the paper from the paper roll. 5. Insert the new paper roll so that the paper flap flows from the bottom upwards and not visa versa and that the end of the paper sticks out of the printer. 6. Close the cover so that it snaps into the housing. 1

2

3

4

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5

6

12. Troubleshooting 12.1. General Contact problems between HAL Handle and HAL Probe will automatically be recognized by the device. When this happens helpful information to solve this problem can be red by pushing the INFO button. If there are other problems try to solve them with the help of the following list.

12.2. Checklist Error

Bad Signal and/or disturbing noise

Possible Reason Water in the plug Bad Contact between tissue and ultrasonic sensor. HAL Probe damaged. Interferences from the mains Sources of interference near to the HAL II Electronic Unit.

Electronic unit is unable to identify the HAL Probe. The device displays an error of the Electronic Unit

The batteries can not be charged

Lifetime of the batteries decreases

The printer does not work

Bad printing quality

Bad contact

Empty batteries Electronic Unit is damaged.

Adapter is damaged (e.g. when the light of the adapter does not light anymore) Plug of the Adapter is damaged Batteries are damaged Electronic Unit is damaged. Old battery pack

No paper in the printer Printing was tried using the wrong menu. The automatic printout is disabled. Wrong paper used Paper wrong inserted (only one side of the paper can be labelled)

Possible Solution Dry the plug Improve the contact between tissue and ultrasonic sensor. Use more ultrasonic gel. Replace HAL Probe Run the device on batteries. Examine the environment and remove sources of interference near to the HAL II Electronic Unit as far as possible. Clean the contacts of the HAL Handle and ensure that the HAL Probe is firmly attached to the HAL Handle (Firmly attach the probe fixation nut). Charge the batteries. Send the HAL II Electronic Unit to your supplier. Replace the HAL Adapter

Replace the battery pack Send the HAL II Electronic Unit to your supplier. Replace the battery pack

Insert paper Change to main menu or info menu1 or info menu2 before pressing MODE/PRINT. Enable the automatic printout in Info screen3 (see menu guidance on page 9). Only use good thermal paper. Insert the paper properly (see “Changing the printer paper roll” on page 14).

Important: If the situation can not be sufficiently improved or if the device does not work anymore then please call your local dealer for repairs / service! Do not attempt to repair the unit yourself! This might be dangerous for you and your patient and the warranty claim would expire.

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13. Technical datasheet Energy sources:

Rated input power: Loudspeaker output: Probe frequency: LCD Display: Thermal printer: Dimensions of the HAL Electronic Unit: Weight: Electrical safety:

Batteries:

Battery operated: DC 6 [V] (battery pack with 5 units Nickel/Metallhydrid Storage Batteries). Net driven via Adaptor: Input: AC 100 - 240 [V] (±10%), 50-60 [Hz] Output: DC 12 [V] 0,21 [A] 2x250 [mW] 8,2 [MHz] Resolution 64 x 240, Backlight Resolution 8 dot/mm x 8 dot/mm Only suitable for thermal paper (Width of reel: 58mm, length of reel: 25m inside diameter: 12mm, outside diameter: max. 48mm) 385 x 140 x 260 [mm] (B x H x T) approx. 3,2 [kg] HAL Electronic Unit, 400 [g] HAL Proctoscope Conform to IEC-60601-1 Class Type B equipment HAL Electronic Unit: IP20 HAL Handle: IPX7, steam sterilisation Nickel/Metallhydrid battery pack Capacity: 5x1,2 [V]/1500 [mAH]

14. Accessories −

HAL II Electronic Unit *

−

HAL Handle *

−

HAL Probe

−

RAR Sleeve

−

HAL II Adaptor*

−

HAL II Rechargeable Battery Pack

−

HAL Knotpusher *

−

HAL Needleholder *

−

HAL Sutures

−

Operating Manual

15. Warranty Warranty is provided for the ‘*’-marked pieces for a period of one year after the date of delivery, assuming that the unit was used under normal, regular conditions. Therefore, in case of any malfunction during the warranty period and thereafter please contact immediately your local dealer!

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16. Reorder Information Order-No. HAL II Electronic Unit

1 unit

AHE 203

HAL Handle

1 unit

AHH 001

HAL Probe Single use

Box / 5 units

AHS 004

A.M.I. Recto Anal Repair Probe A.M.I. Recto Anal Repair Sleeve

Box / 5 units 1 unit

RAR 2011 RAR 2013

HAL II Adaptor (EUROPE)

1 unit

AHA 001

HAL II Adaptor (UK)

1 unit

AHA 002

HAL II Adaptor (USA)

1 unit

AHA 003

HAL II Adaptor (AUSTRALIA)

1 unit

AHA 004

HAL II Adaptor (ROW)

1 unit

AHA 005

HAL II Rechargeable Battery Pack

1 unit

AHR 001cm

HAL Knotpusher

1 unit

AHK 007

HAL Needleholder

1 unit

AHN 006

HAL Suture

Box / 36 units

AHAL 70

Operating Manual

1 unit

Im Letten 1 . 6800 Feldkirch . Austria t +43 5522 90505-0 f +43 5522 90505-4006 e [email protected] . www.ami.at

Issue 06/2007

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