BK Medical T7P2m Transducer User Manual

T7P2m Transducer

LEGAL MANUFACTURER
BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:+45 44528100 / Fax:+45 44528199
www.bkmedical.com
Email: info@bkmedical.com
The connector label on a BK Medical transducer contains information about the date of manufacture.
BK Medical Customer Satisfaction
Input from our customers helps us improve our products and services. Your opinions are important to us. You are always welcome to contact us via your BK Medical representative or by contacting us directly

Introduction

This is the user guide for the T7P2m1 transducer and it must be used together with the Care and Cleaning user guide which contains important safety information.

Caution Rx-c1
United States Federal law restricts this device to sale by or on the order of a physician.

Intended Use

The transducer is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body

Indications for Use

T7P2m is suitable for transesophageal imaging of the heart.

Patient Population

The patient population is adults.

Caution T-c2
The tip of the transducer is very delicate. Handle the transducer gently, especially when you put it down on a hard surface, for example. Also, be careful not to bump the tip.

Figure 1. T7P2m transducer

1. T7P2m has not been licensed by Health Canada for use on the bk5000.

Considerations and Contraindications

Transesophageal or transgastric echocardiograms produce clinical data that are unavailable from any other view, but there are some considerations as to which patients you should use the T7P2m for. First of all, the ability of a patient to swallow or accommodate the transducer, but all gastroesophageal diseases or abnormalities must be considered as well.

Contraindications

• Esophageal spasm
• Esophageal stricture
• Esophageal laceration
• Esophageal perforation
• Esophageal diverticula (e.g. Zenker’s diverticulum)
• Esophageal stent
• Carcinoma of the esophagus or pharynx
• Previous esophageal surgery
• Esophageal varices
• Pharyngeal pouch
• Intra-aortic balloon pump
• Coarctation of the aorta
• Severe coagulopathy
• Large diaphragmatic hernia may significantly hinder TEE imaging because of lack of transducer mucosal approximation.
• Atlantoaxial disease and severe generalized cervical arthritis: TEE should never be performed if there is any question about stability of cervical spine.
• Patients who received extensive radiation to the mediastinum: this can cause significant difficulty in probe manipulation within the esophagus and is a relative contraindication if the anatomy of the esophagus is not known.
• Upper gastrointestinal bleeding significant dysphagia and odynphagia are also relative contraindications.

NOTE: These contraindications are typical examples of what the examining
physician must consider before the examination. The list is not all- inclusive.

**** WARNING Cardio-w2
To avoid patient injury, always remove the transducer from the patient before applying a defibrillator.

General Information

Product specifications, acoustic output data and data about EMC (electromagnetic compatibility) for this transducer can be found in the Product Data Sheet and the Technical Data (BZ2100) that accompany this user guide.

** WARNING** GS-w2
If at any time the system malfunctions, or the image is severely distorted or degraded, or you suspect in any way that the system is not functioning correctly:

• Remove all transducers from contact with the patient.
• Turn off the system. Unplug the system from the wall and make sure it cannot be used until it has been checked.
• Do not try to repair the system yourself.
• Contact your BK service representative or hospital technician.

WARNING AO-w1

To avoid tissue damage, always keep the exposure level (the acoustic output level and the exposure time) as low as possible.

Service and Repair

__ WARNING SR-w1
Service and repair of BK electromedical equipment must be carried out only by the manufacturer or its authorized representatives. BK Medical reserves the right to disclaim all responsibility, including but not limited to responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties. After service or repairs have been carried out, a qualified electrician or hospital technician should verify the safety of all equipment.

Caring for the Transducer

The transducer may be damaged during use or reprocessing, so it must be checked before use for cracks, irregularities, or bite-marks in the surface, following the procedure in Care and Cleaning. It should also be checked thoroughly once a month following the same procedure.
Note that the hard plastic section at the distal end of the transducer should be smooth and firmly attached to the gastroscope shaft.

__Caution T-c9
Never manually deflect the tip of the transducer, use only the control wheels. Do not kink, tightly coil or apply excessive force to the transducer cable or shaft. This might lead to insulation failure.

Reprocessing

To ensure the best results when using BK Medical equipment, it is important to maintain a strict cleaning routine.
Complete details and procedures can be found in Care and Cleaning that accompanies this user guide.
A list of reprocessing methods that the transducer can withstand are listed in the Product Data Sheet. Sterile covers are available. See the Product Data Sheet for more information.

WARNING Reproc-w2
Users of this equipment have an obligation and responsibility to provide the highest possible degree of infection control to patients, co-workers and themselves. The instructions in this book are meant as a guide. To avoid cross-contamination, follow all infection control policies (including for reprocessing, packing and storage) for personnel and equipment that have been established for your office, department or hospital.

Before You Start Imaging

Check the proper mechanical operation of the transducer. Rotate the scan plane with the push-buttons on the handle (see “Transducer Scan Plane” on page 13). Make sure that the rotation is smooth for all scan planes.
Move the tip both left/right and up/down using the control wheels on the handle (see “Using the Transducer Control Wheels” on page 9). Make sure that movement operates smoothly and that you are familiar with the operation of the flexible tip before you use it on a patient.
Before use, all equipment must be reprocessed according to expected use.

**** WARNING T-w5
To prevent electrical shock and damage to the transducer, the connector pins in the transducer plug must always be completely dry before you connect to a system.
**** Caution T-c10
Never spray or rub the tip of the transducer with an anesthetic agent. This could damage the transducer

Starting Imaging

Connecting the Transducer
The transducer is connected to the system using the array transducer socket on the system. To connect, flip the system’s locking lever to the right. Align the transducer plug to the system socket and insert securely. Flip the system’s locking lever to the left to lock it.
When connected, the transducer complies with Type BF requirements of EN60601-1 (IEC 60601-1).
WARNING GS-w4a
It is essential for the patient’s safety that only the correct equipment is used.

• Do not use other manufacturers’ transducers with BK ultrasound systems.
• Do not use BK transducers with other manufacturers’ systems.
• Do not use unauthorized combinations of transducers and needle guides.

Changing Frequency

The multifrequency imaging (MFI) control enables you to select the imaging
frequency. See the applicable system user guide for instructions.

Using a Transducer Cover

WARNING TC-w9
To avoid patient injury, always use a transducer cover

BK recommends the use of a sterile transducer cover to reduce the risk of crosscontamination. See the Product Data Sheet for a list of available transducer covers. Follow local guidelines for the use of transducer covers in your area.
NOTE : In the United States of America, it is recommended to use transducer covers that have been market cleared. In Canada, use only licensed transducer covers. In Europe, transducer covers must be CE-marked.

**** WARNING TC-w1
Some transducer covers can contain latex. Because of reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA advises health-care professionals t o identify their latex-sensitive patients and be prepared to treat allergic reactions promptly.

Apply sterile gel to the tip of the transducer or fill the cover with 1 to 2 ml of sterile water. This improves screen imaging by preventing image artifacts caused by air bubbles.
Follow these precautions when putting sterile covers on a transducer:

• Wear sterile gloves.
• Verify that the cover has not been damaged in the process. If it has, repeat the procedure with a new transducer cover.

** Caution** T-c3
Use only water-based gel (sterile if you are using a sterile transducer cover). Products containing parabens, petroleum, or mineral oils may harm the transducer or transducer cover.

Using a Bite Guard

Place the bite guard in the patient’s mouth before inserting the transducer. The bite guard can also be placed on the transducer so that after the insertion, the bite guard can easily be placed in the patient’s mouth.

** WARNING** T-w10
Always use a bite guard. Failure to use the bite guard may result in damage to the transducer and thereby a risk of patient injury.

Patient Temperature

The patient temperature is set at 37°C (98.6°F) as a default. If the patient has a temperature greater than this, manually enter that temperature on the system. Otherwise, the temperature of the transducer tip may be inaccurately calculated.

** WARNING** Exam-w6
To avoid patient injury, make sure to enter the correct patient core temperature into the system. An incorrectly entered patient temperature may result in esophageal discomfort.

Adjusting Patient Temperature

bk3000 and bk5000 Ultrasound Systems:

1. Start the Exam.
2. Click Patient Temp on the image tab.
3. Adjust the patient temperature using the scale button.
4. Click to set the temperature.
   
   Figure 2. Patient Temp scale button
   The patient temperature will be displayed in the image data at the top of the monitor to the left of the ultrasound image just above transducer temperature.

Figure 3. Patient Temperature in image data

bk3500 Ultrasound System:

1. Start the Exam.
2. Tap Patient Temperature on the touch screen.
3. Adjust the patient temperature using the related dial.
   The patient temperature will be displayed in the image data on the system monitor, just above the transducer temperature.

Transducer Temperature

The temperature of the tip is monitored by the system, and is displayed in the image data on the system monitor. If the temperature passes 41°C (105.8°F), the position indicator turns yellow, and a message is displayed telling you that the temperature in the transducer is elevated, you should freeze the image and wait for the temperature to come down. But also to check the patient temperature to make sure that the right temperature is entered in the system.

Figure 4. Position indicator turns yellow at temperature above 41°C on bk5000

Should the temperature reach 43°C (109.4°F), an alarm will sound and the freeze function is activated. A message is displayed to tell you that scanning is frozen. The position indicator will turn red.

Figure 5. Position indicator turns red at temperature above 43°C on bk5000

When the transducer temperature falls to 42°C, scanning will resume.

Operation of the Flexible Tip

WARNING T-w11
Avoid violent manipulations and excessive force when using the transducer, as this can result in patient injury.

Transducer Controls

The flexible tip is controlled by:

• 2 wheels for the orientation of the flexible tip, placed on top of the transducer handle.
• 2 lock switches to manage the action of the control wheels. These 2 switches are located beneath the control wheels on the side of the transducer handle.
• 2 push buttons to control the scan plane rotation, clockwise and counterclockwise respectively.

Using the Transducer Control Wheels

The control handle is designed for one-handed operation. Thumb, index finger and middle fingers control the 4-way control wheels, locking switches and scan plane rotation push buttons.
The top wheel controls the left/right motion of the flexible tip. The bottom wheel controls the up/down motion of the flexible tip. The action of the wheels can be switched between a smooth continuous action and a more restrained action where the tip is locked between movements of the wheel.
Each wheel has a separate lock switch that controls its action, and these switches are used independently.
Neutral Position is when the tip is in zero position (see Fig. 10) and the movement of the tip is not locked.

Figure 6. Control handle of the T7P2m (array to the left, cable to the right).

Adjustment of the Flexible Tip

The flexible tip of the transducer can be adjusted through an angle of 120° upwards, 90° downwards and 45° to the left and right. See Fig. 7 and Fig. 8.
The position of the tip is adjusted by the control wheels on top of the transducer handle.

Figure 7. Movement of the T7P2m flexible tip. Up and down.

Figure 8. Movement of the T7P2m flexible tip. Right and left.

WARNING T-w8
To avoid patient injury and risk of ‘buckling’ or ‘U-turning’ in the esophagus, ensure that the maximum movement of the tip is 90° to 120° upwards, 60° to 90° downwards and 30° to 45° left and right before inserting the transducer. If movement exceeds the maximum angles given above, do not use the transducer. Contact your BK service representative to have the steering of the transducer readjusted.

Lock Switches

The lock switches are located beneath the control wheels on the side of the transducer handle. See Fig. 9. Push the button on the right side (back) of the transducer handle to activate the lock switch, and on the left side (front) to deactivate it.

Figure 9. Lock switches front (press to deactivate) and back (press to activate).

WARNING T-w9
To avoid patient injury, unlock the control wheels and set them in zero position when inserting or withdrawing the transducer.

Zero Position

Figure 10. Control wheels zero position

Both control wheels have a zero position. This position is indicated by a line on the control wheel and transducer handle, and a slight click when these lines are aligned. When both wheels are adjusted to the zero position, the tip of the transducer will be in the straight, non-adjusted, zero position.

Transducer Scan Plane

The transducer scan plane can be rotated from 0° (transversal plane) via 90°
(longitudinal plane) to 180° (transversal plane, left/right inverted). You can also chose any plane in between. This makes it possible to scan a conical imaging volume.

Figure 11. Transducer scan plane.

The current rotation angle is displayed in the top left corner of the image on the monitor:

Figure 12. Scan plane rotation angle on the system monitor.

WARNING PN-w1
To avoid pressure necrosis, remove the tip from the esophagus wall when you are not imaging. Do this by releasing the tip to the neutral position.

Changing Orientation

To change the orientation of the image on the monitor, refer to the applicable system user guide for instructions.

Cleaning after Use

WARNING Reproc-w3
Immediately after use, you must pre-clean the device until visually clean (including device lumens if existing). Conduct the thorough cleaning process as soon as possible after use in order to prevent bioburden drying on the surface. Dried bioburden can lead to inefficient cleaning, disinfection and sterilization, causing a risk of cross-contamination.

Disposal

When the transducer is scrapped at the end of its life, national rules for the relevant material in each individual land must be followed. Within the EU, when you discard the transducer, you must send it to appropriate facilities for recovery and recycling.

**** WARNING D-w1
For disposal of contaminated items such as transducer covers or needle guides or other disposable items, follow disposal control policies established for your office, department or hospital.

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