ACUSON P500 Supplement to the User and Reference Manuals Sw Ver VC10

Supplement to the Instructions for Use (English) The supplement provides updated information for your existing user manuals. Refer to your ultrasound system's user and reference manuals for a complete set of operating instructions.

Cart Labels (New content: Instructions for Use, Chapter 2)

Example of the location of the standard cart label.

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1

2

Example of the standard cart label. 1 2

Safe working load Location of the identification label

1 2

Item :

For use with :

Example of an identification label for a standard cart. 1 2

Name of accessory Name of product compatible with the accessory

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Standard Cart (New content: Instructions for Use, Chapter 3) 1

2

11

3 4

10

5

9 6

8

7

Example of the standard cart, front view. 1 Guides to secure the ultrasound system to the cart 2 Back handle 3 Guides to secure the ultrasound system to the cart 4 Multiple transducer module 5 Transducer cable holder 6 Accessory shelf 7 Wheel with a locking lever 8 Storage bin 9 Black and white printer 10 Front handle 11 Transducer holder

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Example of the standard cart, back view. 1 2 3

Height adjustment lever Universal video converter Multiple transducer module connector

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To Secure the ultrasound system to the standard cart

Do This WARNING: To avoid patient or user injury and damage to the ultrasound system, ensure the system is removed from the standard cart during transport. WARNING: Ensure the system is secured on the standard cart properly prior to using the system. WARNING: Carefully place the ultrasound system on the standard cart. A potential pinch point between the bottom of the ultrasound system and the top of the standard cart can create a risk for injury to the user. 1. Align the holes on the bottom of the ultrasound system with the guides on the top of the cart. 2. Press downward firmly on the system. 3. Gently pull up on the ultrasound system handle to verify the system is secure.

Adjust the height of the standard cart

 To raise the cart height, gently pull upward on the height adjustment lever while pulling the cart handle upward.  To lower the cart height, gently pull upward on the height adjustment lever while pushing the cart handle downward.

Remove the ultrasound system from the standard cart

Prerequisite: Disconnect all devices and cables from the system, including transducers, power cord, and peripheral devices.  Lift the ultrasound system upward to separate the system from the cart.

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Securing the Wheel Locks

Example of the locking wheels on the standard cart, unlocked (left) and locked (right).

To lock and unlock the wheels of the standard cart: 

To set the lock and prevent the wheels from rolling and swiveling, press the bottom of the locking lever downward with your foot.

LOCK 

To unlock the wheels on the standard cart, press the top of the locking lever downward with your foot.

FREE

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Protective Transducer Holders (New content: Instructions for Use, Chapter 3)

Example of transducer holders on the standard cart. 1 2 3

Point of attachment Holder Tab

To attach a transducer holder to the standard cart: 

Align the tab on the transducer holder with the point of attachment on the rail and then slide the holder downward until the holder snaps into place.

To remove a transducer holder from the standard cart: 

Pull the holder upward from the rail.

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Multiple Transducer Module (Updated content: Page 3-21, Instructions for Use)

Multiple Transducer Module for Standard Cart

Example of the multiple transducer module. 1 2 3

Connector for the ultrasound system Transducer locks Transducer ports

To connect the multiple transducer module to the system: 1.

Make sure the transducer locking lever on the right side of the ultrasound system is in the unlocked position.

2.

Insert the connector from the module into the transducer port, taking care to align the connector for a smooth fit. Push the locking lever to the locked position.

3.

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To remove the multiple transducer module from the system: Caution: To avoid damage to the multiple transducer module, you must disconnect the module from the ultrasound system prior to removing the ultrasound system from the cart.



Push the locking lever to the unlocked position and then pull the connector away from the transducer port on the ultrasound system.

Caring for Transducers (New content: Page 6-4, Instructions for Use) Transducer Element Check A transducer element check is available for evaluating the integrity of each element on a transducer. If you suspect transducer degradation due to damage, age, or another issue, contact your customer service representative. Based on the results of the transducer element check, your customer service representative will advise you of necessary actions.

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Disinfecting a Continuous Wave Transducer (New content: Page 6-12, Instructions for Use) A continuous wave (CW) transducer with a T-bar requires additional tasks for disinfection. To prepare a CW transducer for disinfection: 1. 2. 3.

Rotate the screw on the side of the T-bar counterclockwise and then set the screw aside. Loosen and then slide the T-bar onto the transducer cable. Perform the additional tasks when following the disinfection instructions on page 6-11. – Carefully wipe the T-bar and screw using a disinfectant wipe. 

Use a circular motion when wiping the T-bar and screw.



Slide the wipe partially through the hole on the T-bar and then rotate the T-bar to disinfect the interior of the hole.



Slide a portion of the wipe into the threaded screw hole on the T-bar and rotate the wipe to clean the interior of the hole.

–

Carefully wipe the transducer, including the cable, using a second disinfectant wipe.

–

Allow all surfaces to remain wet with disinfectant for a minimum of two minutes. Reapply the disinfectant to the transducer, T-bar, and screw, if necessary. Note: Follow the disinfectant manufacturer's instructions.

– 4.

Rinse and then dry the transducer, T-bar, and screw.

Reassemble the transducer after all components are dry. a. Carefully slide the T-bar into place on the transducer. b. Rotate the screw clockwise into the T-bar to secure the T-bar to the transducer.

Options (New content: Instructions for Use, Appendix A) Options

Description

Standard Cart

 Removable and repositionable transducer holders: up to 4  Optional accessory shelf  Storage bin  Wheel locks  Optional multiple transducer module for connecting up to three transducers to the ultrasound system

Remote Services Option

 Enables a Siemens Healthineers representative to remotely view and control your system  Requires using the phone number provided by your Siemens Healthineers representative to initiate remote assistance. The representative guides you through the setup of each communication session

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Standard Cart Maximum Physical Dimensions (New content: Instructions for Use, Appendix A) Width:

60.5 cm

Height:

65.9 cm to 92.1 cm

Depth:

53.5 cm

Weight:

21.4 kg Safe working load not to exceed 57 kg The weight includes the multiple transducer module, accessory shelf, storage bin, and four transducer holders installed on the standard cart.

Updates to System Compliance Classification (Updated content: Page A-29, Instructions for Use, Page A-6, System Reference) (Applicable only for the ACUSON P500 3.0 ultrasound system) Note: The ultrasound system is a Class A device when the barcode reader, universal video converter, catheter, or 5VT transducer is in use.

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Errata to the User and Reference Manuals (English) The errata provides corrected information for the user and reference manuals. Refer to your ultrasound system's user and reference manuals for a complete set of operating instructions.

System Labels (Updated content: Page 2-10, Instructions for Use)

1

Example of an ultrasound system label.

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Connecting to Remote Services (Updated content: Page 3-37, Instructions for Use) (Available only when remote services is enabled on your ultrasound system) You can connect to remote services through a wired or wireless network. To begin the remote access session: 1. 2.

Use the phone number provided by your Siemens Healthineers representative. Follow the instructions provided by your service representative, including how to disconnect from the remote service session. Note: If you do not disconnect from the session, the session will end after 30 minutes of inactivity.

Activating Anti-Virus Protection (Updated content: Page 3-44, Instructions for Use) Caution: Disabling anti-virus protection causes system vulnerability to external security threats. We recommend enabling anti-virus protection to prevent unauthorized software installation or activation of unsafe executable files and for allowlisting trusted applications. Enabling anti-virus protection may slightly increase the system startup time.

Use the configuration settings to enable or disable McAfee Application Control anti-virus protection on the ultrasound system. To enable or disable anti-virus protection: 1. 2. 3. 4.

Access the configuration settings and then tap Service. Click Service to access the settings in the service software. Click OK to display the user-configurable settings. Click McAfee Application and then select an option. – On enables anti-virus protection. –

5.

Off disables anti-virus protection.

To save the changes: a. Click Save. The system displays a confirmation message. b.

Click OK. The system restarts after processing the anti-virus protection option. Note: Do not power off the ultrasound system while the anti-virus protection option is being processed.

The system saves the selected setting and restarts the ultrasound system. 6.

To exit without saving the changes, click Home. Or, click Finish.

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List of Approved Cleaners (Updated content: Page 6-12, Instructions for Use) See also: For an additional list of approved cleaners and disinfectants, refer to the Transducer Cleaners and Disinfectants Addendum. You can also access the most recent compatible cleaners and disinfectants on the Siemens Healthineers web site.

List of Approved Disinfectants (Updated content: Page 6-13, Instructions for Use) See also: For an additional list of approved cleaners and disinfectants, refer to the Transducer Cleaners and Disinfectants Addendum. You can also access the most recent compatible cleaners and disinfectants on the Siemens Healthineers web site.

trophon2, Sonex-HL*

trophon2, NanoNebulant *

trophon EPR, Sonex-HL*

trophon EPR, NanoNebulant*

Super Sani-Cloth Germicidal Disposable Wipes

Sani-Cloth AF3 Germicidal Disposable Wipes

Revital Ox RESERT HLD

gigasept FF (new)

CIDEX OPA

Note: An approved disinfectant may discolor the transducer. There is no associated degradation of imaging performance or transducer reliability.

CH5-2



















VF10-5



NA















VF13-5



















VF16-5



















L10-5v



NA







NA

NA

NA

NA

EC9-4



















P4-2



















11M3







NA











18H5



NA





NA









P8-4



















CW2





NA





NA

NA





CW5





NA





NA

NA





 = approved NA = not approved *An asterisk (*) indicates a reprocessing device with the approved disinfectant for use. For information about the reprocessing device, refer to the device manufacturer's instructions for use.

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Options (Deleted content: Page A-15, Instructions for Use) Options

Description

Virtual Communication for eSieLink Remote Assistance

 Enables virtual communication for remote assistance with a Siemens Healthineers representative.  Requires using the phone number provided by your Siemens Healthineers representative to initiate remote assistance. The representative guides you through the setup of each communication session  Includes a headset, camera, and camera attachment

eSie Prep

 Provides pre-configuration of Internet Based Connectivity (IBC) and Smart Remote Services (SRS) connection

Cybersecurity (Updated content: Page C-6, C-13, Instructions for Use) The following text replaces the existing text, Smart Remote Services, on pages C-6 and C-13 in your manual: 

Remote customer services

Approved Cleaners and Disinfectants for the Transesophageal Transducer (Updated content: Page B3-24, Clinical Applications Guide) See also: For an additional list of approved cleaners and disinfectants, refer to the Transducer Cleaners and Disinfectants Addendum. You can also access the most recent compatible cleaners and disinfectants on the Siemens Healthineers web site. Transducer

Approved Cleaners

Approved Disinfectants

5VT

ANIOSYME DD1

ANIOXYDE 1000

ENZOL

CIDEX OPA

Matrix Wipes

gigasept FF (new)

Protex ULTRA Disinfectant Wipes

MetriCide OPA Plus

TEEZyme

TD-51

Transeptic

TD-81 Tristel Trio Wipes System

For use with the TD-100 Automated TEE Probe Disinfector according to the device manufacturer's instructions for use.

1

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Enabling Ports (Updated content: Page 1-18, System Reference) Port Number

Port Group

Protocol

104

DICOM

TCP

80

Remote Services

TCP

443

M-Mode Measurement Labels (Updated content: Page D-10, System Reference) Measurement Label Mitral Valve(M)

Description

Measurement Method

Mitral Valve function

---

DE Slope

Anterior excursion of the mitral leaflet at early diastole.

Slope

DE excursion

Amplitude of the early diastole wave

Distance

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Beispiel eines Standardwagens, Rückansicht. 1 2 3

Höhenverstellhebel Universeller Videokonverter Anschluss für das Multi-Schallkopf-Modul

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1

2

Exemple d'étiquette du chariot standard. 1 2

Charge maximum pratique Emplacement de l'étiquette d'identification

1 2

Item :

For use with :

Exemple d'étiquette d'identification pour un chariot standard. 1 2

Nom de l'accessoire Nom du produit compatible avec l'accessoire

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Enabling Ports (Updated content: Page 1-18, System Reference) Port Number

Port Group

Protocol

104

DICOM

TCP

80

Remote Services

TCP

443

M-Mode Measurement Labels (Updated content: Page D-10, System Reference) Measurement Label Mitral Valve(M)

Description

Measurement Method

Mitral Valve function

---

DE Slope

Anterior excursion of the mitral leaflet at early diastole.

Slope

DE excursion

Amplitude of the early diastole wave

Distance

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