24967 Patient Connector Clinician and Technical Manual Rev A Aug 2019

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners. CareLink, Medtronic

Contents 1

Introduction to the 24967 Patient Connector... 1.1 Explanation of packaging and product symbols... 1.2 Description... 1.3 Intended use... 1.4 Contraindications... 1.5 Warnings... 1.6 Precautions... 1.7 Regulatory compliance... 1.8 Patient Connector functions... 1.9 IT network, mobile device, and data information...

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Setup and configuration... 2.1 Contents of package... 2.2 System components... 2.3 Compatible accessories... 2.4 Setup... 2.5 Charging the patient connector battery... 2.6 Pairing the patient connector with the app... 2.7 Troubleshooting potential interference...

10 10 10 11 12 13 14 15

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Conducting a patient session... 3.1 Positioning the patient connector... 3.2 Communicating with an implantable device... 3.3 Troubleshooting...

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Maintaining the patient connector... 4.1 Cleaning and disinfecting the 24967 patient connector... 4.2 Replacing the patient connector nose, cable, and weight... 4.3 Software updates... 4.4 Specifications...

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Electromagnetic compatibility declaration... 24

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1 Introduction to the 24967 Patient Connector 1.1 Explanation of packaging and product symbols Refer to the package label and product to see which symbols apply to this product. Consult instructions for use at www.medtronic.com/manuals.

Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union Acts. Ingress protection Use only with specified power supply

Class II ME equipment equipment

Type BF applied part

Type CF applied part

Humidity limitation

Non-ionizing electromagnetic radiation

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.Medtronic.com for instructions on proper disposal of this product. Direct current Manufacturer

Date of manufacture

Authorized representative in the European community

For US audiences only Caution: Federal law (USA) restricts this device to sale by or on the order of a physician

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Re-order number

Serial number

Package contents

Product documentation

Accessories

Magnetic Resonance (MR) Unsafe

Bluetooth connection

Wireless communication enabled

Telemetry enabled

Caution: Strong magnet

Follow instructions for use (blue)

Low battery Keep dry

ACMA (Australian Communications and Media Authority) and the New Zealand Ministry of Economic Development Radio Spectrum Management compliance mark for Australia and New Zealand System meets the applicable Canadian and U.S. IEC safety standards

Technical Conformity (Ministry of Internal Affairs and Communications) mark for Japan Operating temperature

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Transit temperature

Storage temperature

Security key

24970A Device manager

24967 Patient connector

249701 Power supply (for the 24970A base)

249705 Power cord (for the 24970A base)

249651 Power supply (for the 24967 patient connector)

249672 Tether Kit

249702 USB Cable

249671 Weight Kit

1.2 Description The 24967 Patient Connector telemetry head (referred to from now on as the patient connector), pairs with Medtronic apps on your mobile device to interrogate and/or program implantable Medtronic devices. The patient connector includes these features: • Low frequency inductive telemetry to communicate with implantable Medtronic devices. ® • Bluetooth wireless technology to communicate with implantable Medtronic devices and the apps running on the mobile device.1 • Integration with the Medtronic 24970A Base for charging (not included).

1.3 Intended use The patient connector is intended to be used with Medtronic apps to interrogate, analyze, and/or program implantable Medtronic devices. The patient connector uses Bluetooth technology to transmit that data to a Medtronic app for further processing. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment

1 The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any such use of those marks by Medtronic

is under license.

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1.4 Contraindications There are no known contraindications for the use of this device.

1.5 Warnings These warnings apply in general to using the patient connector settings. For more information related to specific implantable device models, see the reference guides for the implantable device and the software. Battery exposure – Exposing the patient connector to cold temperatures may result in a loss of performance and shortened patient connector service life. Connection of external devices – Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards. All configurations must comply with the requirements for medical electrical systems, see IEC 60601-1 and IEC 60601-1-1. Anyone connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Local laws take priority over the above mentioned requirements. If in doubt, consult your local Medtronic representative or the technical service department. Damage due to impact – Do not use the patient connector if it has sustained impact damage. Internal components may be damaged or exposed. Use of damaged equipment may impact user or patient safety. Magnetic Resonance (MR) Unsafe – The patient connector is MR Unsafe. Do not bring the patient connector into Zone 4 (magnet room), as defined by the American College of Radiology. Modification of equipment – Do not modify this equipment. Modifications may reduce system effectiveness and impact user or patient safety. Modifying the patient connector without the approval of Medtronic could void the user’s authority to operate the equipment. Radio-frequency (RF) interference – Portable and mobile RF communications equipment can interfere with the operation of the patient connector. Although the patient connector has been approved, there is no guarantee that it will not receive interference or that any particular transmission from the patient connector will be free from interference. Unauthorized use – The patient connector can be used with any compatible mobile device onto which the app is installed. Inappropriate programming could result if untrained persons obtain the patient connector and a patient with a Medtronic implantable heart device allows them to use it with the patient’s device. Use of unapproved power supply – Use only the Medtronic-supplied power supply with the patient connector. Use of an unapproved power supply may damage equipment or impact user or patient safety.

1.6 Precautions Attaching the tether kit – Do not overtighten the screw when attaching the tether kit. Autoclaving – Do not autoclave the patient connector. Damaged equipment – Periodically, inspect the patient connector, connection port, and cord for damage. If the case of the patient connector is cracked, or if the power supply connector is damaged, contact your Medtronic representative. Replace the power supply if there is damage to it. Dispose of the damaged power supply according to local regulations or return the part to Medtronic. Do not immerse – Take care to prevent liquid from entering the patient connector. Do not immerse the patient connector or any accessories in any liquid or clean them with aromatic or chlorinated hydrocarbons. Maintenance and service – Do not modify or do any maintenance or service on the patient connector while you are using it. Doing any of these tasks on the patient connector while it is in use can lower its effectiveness. Contact Medtronic at the number on the back cover of this manual if your patient connector is not working properly. Product and packaging labels and information – If labels or information appear to be missing from the product or packaging, contact your local Medtronic representative at the address and telephone number located on the back cover of this document. Security – Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Bluetooth communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm. Sterility – The patient connector is not sterile and cannot be sterilized. For applications in which a sterile environment must be maintained, place the patient connector inside of the Medtronic Model 6177 sterile sleeve. Use of wireless devices – The patient connector incorporates radio-frequency (RF) communications components which may affect other devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. RF interference may affect device performance. Electromagnetic Compliance (EMC) testing shows that the patient connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. However, there is no guarantee that interference will not occur in a particular installation.

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If the patient connector does cause harmful interference to other devices or is negatively impacted by other devices, correct the interference by one or more of the following measures: • Reorient or relocate the patient connector and other devices. • Increase the separation between the patient connector and other devices by at least 2 m (approximately 6 feet). Other devices include, but are not limited to, cellular phones, computer screens, wireless network devices, and ‘walkie-talkies’. • Turn off any interfering equipment. 1.6.1 Environmental precautions To ensure safe and effective operation, use the patient connector with care to avoid damage to the patient connector from environmental factors that may impair its function. Care is exercised in design and manufacturing to minimize damage to the patient connector under normal use. However, the patient connector is susceptible to many environmental stresses including, but not limited to, the following examples. • The patient connector is designed to be used indoors in a clinical or hospital environment. • Do not drop or mishandle the patient connector or damage may occur. Damage can impair the functionality of the patient connector. Even if the patient connector works immediately after being dropped, operational damage may have occurred that may not be observed immediately. • Do not spill fluid on the patient connector. Fluid incursion can occur and cause damage to the patient connector. • The patient connector may be affected by electrostatic discharge (ESD). In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the patient connector. • Do not open the case of the patient connector. The patient connector is constructed to minimize risk from environmental factors. Opening the case of the patient connector can make it susceptible to environmental factors and can expose the patient or user to hazardous voltage or current. • Do not expose the patient connector to rapid temperature changes. Rapid temperature changes may affect proper operation of the patient connector. If the patient connector is exposed to rapid temperature changes, allow the temperature to stabilize before using it. • Do not store or operate the patient connector for prolonged periods of time in high humidity. Prolonged storage or operation of the patient connector in high humidity can affect proper operation. If the patient connector is damaged, contact Medtronic at the telephone number on the back cover of this manual. Other environmental factors can impair the performance of the patient connector. Always use good health management practices to prevent environmental damage to the patient connector.

1.7 Regulatory compliance 1.7.1 US Federal Communications Commission (FCC) This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

1.8 Patient Connector functions The patient connector communicates with an implantable device. The patient connector also communicates with the Medtronic app running on a mobile device.

1.9 IT network, mobile device, and data information 1.9.1 Required IT network characteristics and configuration The use of the patient connector requires your network to have Internet access for the following purposes: • Download and install the Medtronic app from the app store. • Download and install Medtronic app updates and software updates for the patient connector. • Register, download, and install app configuration files from the Medtronic Application Services (MAS), if the Medtronic app allows it. • Send data to the CareLink Network, if the Medtronic app allows it. Failure to provide IT network access results in the following effects: • You cannot install or update the Medtronic app because the mobile device is unable to access the Internet. • You cannot install periodic updates and security enhancements that maintain the security of the Medtronic app because the mobile device is unable to access the Internet. • You cannot send downloaded Medtronic implantable device data to the CareLink Network.

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To use the Medtronic app, you must also enable Bluetooth wireless technology on your mobile device. The patient connector communicates with the Medtronic app installed on the mobile device through a Bluetooth connection. Failure to provide Bluetooth wireless communication access prevents the patient connector from communicating with the Medtronic app. If Bluetooth connectivity is disabled, the patient connector cannot interrogate, analyze or program Medtronic implantable devices. Follow your organization’s processes and policies to configure your network and your mobile device. 1.9.2 Supported mobile devices and technical specifications For a list of supported mobile devices and their specifications, including network connectivity specifications, go to the following website: www.medtronic.com/24967 1.9.3 Intended information flows Data is sent for processing through the system components in the following sequential order: • Implantable device • 24967 patient connector • Medtronic app running on the mobile device System logs are sent for processing through the system components in the following sequential order: • • • •

24967 patient connector Medtronic app running on the mobile device Internet Medtronic Application Services (MAS)

During installation and updates, the app sends clinic registration and device manager system credentials to Medtronic Application Services via the Internet for authentication. In response, Medtronic Application Services returns configuration files to the app via the Internet to install or update the app and component software as needed. All information in transit is protected for security. 1.9.4 Precautions when connecting to your IT network Connecting this system to an IT network that includes other equipment could result in unforeseen risks to patients, operators, or third parties. Changes to your IT network, such as adding, disconnecting, and upgrading equipment or changing network configurations could also introduce additional risks. Analyze, evaluate, report, and control any risks identified. 1.9.5 Data transmissions The patient connector uses Bluetooth wireless technology to communication with the Medtronic app installed on the mobile device. Data transmission rates over Bluetooth connections are highly dependent on the environment in which the patient connector and mobile device are used. Transmission rates may degrade based on electrical interference from other radio emitters, distance between the patient connector and the mobile device, and wireless or cellular settings on the mobile device. Maximum data throughput in an ideal environment is 2.1 Mbit/s with a latency of 5 to 10 ms. All data transmitted between the patient connector and the app is encrypted for data privacy. Data integrity is maintained through standard communication protocols for error detection. 1.9.6 Security Data in the Medtronic app is protected by application level encryption. The app does not provide data protection for data exported to another destination. Data exported from the app should be handled in accordance with your clinic’s security policy for data handling and storage. To protect the system, Medtronic recommends you implement the following security measures: • • • •

Use the Medtronic app and system components only on a managed, trusted network. Secure your network with anti-virus software or a firewall, in line with your IT department’s policies. To help protect patient health information, implement security measures such as a passcode and PIN to protect the mobile device. Ensure security certificates match before connecting to Medtronic Application Services for app updates.

If you suspect a cybersecurity event has occurred, stop using the app (if possible) and contact your IT Security or Biomedical department for information on how to confirm and respond to the suspected incident.

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2 Setup and configuration 2.1 Contents of package The package contains: • • • •

Model 24967 Patient Connector MENB1020A0500XXX Power Supply (Medtronic re-order number: 249651) Model 249652 Tether Kit Literature

2.2 System components Figure 1. Patient connector components

1 Weight (blue) 2 Patient connector

3 Tether kit 4 Power supply

Patient connector – Provides the communication link between the app and the patient’s implantable device. The patient connector contains a radio-frequency (RF) transmitter and receiver. It must be placed over the implantable device during a communication session. The patient connector has a blue counter weight, and when it is unwrapped and placed over the patient’s shoulder can hold the patient connector in place hands-free. Mobile device (not included) – When running the Medtronic app and paired with the patient connector, provides the user interface to communicate with the implantable device, depending on the app installed. Power supply – Connects to an AC power outlet to charge the patient connector battery. Tether kit – Semi-permanently connects the patient connector to the power cord. Contains a Torx wrench, screw, and cable retainer. Warning: Do not modify this equipment. Modifications may reduce system effectiveness and impact user or patient safety. Modifying the device without the approval of Medtronic could void the user’s authority to operate the equipment. 10

2.2.1 Indicator lights Figure 2. Patient connector indicator lights

1 Telemetry status 2 Bluetooth connection status Table 1. Patient connector icons and indicator lights Icon Indicator Telemetry status

Bluetooth connection status

Battery status

3 Battery status

Color Amber

State Solid

Green

Solid

Blue

Flashing

Blue

Solid

Amber Green

Solid Flashing

Green

Solid

Description The patient connector is out of range of the implanted device. The patient connector is actively communicating with the implanted device. The light becomes brighter when the signal from the implanted device is stronger. The patient connector is broadcasting its status or is being paired with the mobile device. The patient connector is connected to the mobile device. The patient connector battery is low. The patient connector battery is charging. The patient connector battery is fully charged.

2.3 Compatible accessories The following compatible accessories are available for the patient connector: • • • • •

MENB1020A0500XXX power supply (Medtronic re-order number: 249651XX), 2 m (approximately 6.5 feet) Model 249672 tether kit Model 6177 sterile sleeve (not included) Model 24970A Base (not included) Model 249702 USB cable, approximately 3 m (10 feet) (not included)

Contact your local Medtronic representative to order them. Warning: Use the Medtronic-supplied components only. Use of unapproved components may reduce device effectiveness or impact user or patient safety.

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2.4 Setup This section describes how to: • • • •

Power on the patient connector Power off the patient connector Download the app Attach the optional tether kit

2.4.1 Powering on the patient connector 1. Locate the button on top of the patient connector. Figure 3. Locate the patient connector button

1 Patient Connector button 2. To power on the patient connector, press and release the button. The Bluetooth connection status light flashes when the patient connector is turned on. 2.4.2 Powering off the patient connector If the patient connector is not charging and has not been paired with the app, it powers off automatically after 5 minutes of inactivity. If the patient connector is not charging and has been paired with the app, for example after a patient session, it powers off automatically after 15 minutes of inactivity. If the patient connector is charging, the Bluetooth radio turns off automatically after 5 minutes of inactivity. 2.4.3 Downloading the app 1. Make sure the mobile device is connected to the Internet. 2. Navigate to the app store and locate the app. 3. Tap the app download button to download the app onto the mobile device. 4. Install the app. 5. Tap the app icon to open it. 6. Follow the instructions in the app to complete the installation. 2.4.4 Attaching the optional tether kit The tether kit provides a way to semi-permanently attach the patient connector to the power supply cord. This is an optional configuration. 1. Locate the power supply connector cover on the bottom of the patient connector. 2. Use the Medtronic-supplied wrench to remove the screw.

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3. Remove the power supply cover from the patient connector.

4. Plug the power supply into the patient connector.

5. Slide the cable retainer over the power supply plug of the power cord.

6. Insert the screw into the bottom of the cable retainer and tighten the screw using the Medtronic-supplied wrench.

Caution: Do not over tighten the screw when attaching the tether kit. Warning: Use the Medtronic-supplied components only. Use of unapproved components may reduce patient connector effectiveness or impact user or patient safety.

2.5 Charging the patient connector battery Caution: Charge the patient connector before use. If the patient connector is not adequately charged before beginning a procedure, you may not be able to complete that procedure. Charge the patient connector using the Medtronic-supplied power supply. There are two additional ways to charge the patient connector using the 24970A base. For more information on charging, refer to the instructions for use provided with the 24970A base. Contact your Medtronic representative for details. Notes: • The patient connector and power supply form a medical electrical system when connected. • If you need to disconnect the patient connector from the AC power mains, the power supply is the power disconnect at the mains outlet. • Position the patient connector so that it can be easily disconnected or unplugged from the wall. • The third conductor in the power supply plug, if present, is a functional earth connection. • If the operational time between charges decreases or the patient connector internal rechargeable battery no longer retains a charge, contact Medtronic for a replacement 2.5.1 Charging using the power supply Connect the power supply to the patient connector and to an AC power outlet (AC mains) to charge the patient connector.

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1. Open the power supply connector cover located on the bottom edge of the patient connector. 2. Connect the power supply cord to the patient connector. 3. Plug the power supply into the AC power outlet (AC mains). Warning: Use only the Medtronic-supplied power supply to power the patient connector. Use of an unapproved power supply may damage equipment or impact user or patient safety.

2.6 Pairing the patient connector with the app The patient connector uses a Bluetooth connection to communicate with the app running on the mobile device. You will need to pair each patient connector to the mobile device. 1. Enable Bluetooth on the mobile device, if it is not enabled. 2. Open the app. 3. Follow the instructions in the app to continue. 4. Enter the patient connector model number, if you are prompted. The model number is located on the back of the patient connector. 5. Turn on the patient connector by pressing the button when prompted by the app. The Bluetooth connection status light on the patient connector flashes when it is being paired with the mobile device, and is solid when communication is established with the mobile device. 6. When prompted by the app, select the patient connector you want to use from the list.

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7. Locate the security key code on the back of the patient connector. Figure 4. Patient Connector security key

1 Security key symbol 2 Security key code 8. Enter the security key code and follow the instructions in the app to continue. 9. Accept the Bluetooth pairing request on the mobile device. 10. Complete the configuration steps in the app.

2.7 Troubleshooting potential interference Interference between the patient connector and other electronic equipment can result in reduced quality of service. Reduced quality of service could result in slow data transmission speeds or poor communication strength. For more information on app-specific error messages see the instructions for use provided with the Medtronic app. To address possible interference between the patient connector and other electronic equipment, take one or more of the following measures: • • • • •

Reorient or relocate the electronic equipment. Increase the separation between the patient connector and the electronic equipment. Connect the electronic equipment to an outlet on a different circuit, if the patient connector is plugged into the outlet for charging. Move the patient connector and mobile device closer together. Consult Medtronic for help.

3 Conducting a patient session 3.1 Positioning the patient connector The patient connector can either be balanced over the patient’s shoulder using the blue weight for hands-free use or held over the implanted device. The patient connector, blue weight, and cord come into physical contact with the patient during normal use of the device. Use the Model 6177 sterile sleeve if sterility is a concern. 1. For hands-free use, unwrap the blue weight and cord from the patient connector and place the weight over the patient’s shoulder. 2. Position the patient connector over the implantable device. Note: The bottom of the patient connector must be parallel to and typically within 5 cm of the implantable device. 3. Verify that the green telemetry status light on the patient connector is on. The telemetry status light will become brighter when the signal from the device is stronger. This indicates better telemetry. For best telemetry performance, do not use the patient connector close to sources of electrical noise or interference.

3.2 Communicating with an implantable device To ensure good Bluetooth communication, make sure the mobile device is no further than 2 m (6.5 feet) from the patient connector during the patient session. Caution: Charge the patient connector before use. If the patient connector is not adequately charged before beginning a procedure, you may not be able to complete that procedure. Note: Place the Model 6177 sterile sleeve over the patient connector if the patient connector is being used in a sterile environment.

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1. Tap the app icon to open it. 2. If the patient connector isn’t already on, turn on the patient connector by pressing the button. 3. Place the patient connector over the implantable device. The telemetry status light on the patient connector is green when communication is established with the implantable device. The telemetry status light is brighter when there is a stronger signal. 4. Follow the instructions in the app to start communicating with the implantable device. 5. Leave the patient connector over the implantable device until the communication is complete. Communication can take up to 5 minutes. Caution: Only use the patient connector to communicate with the intended implanted device. Avoid placing the patient connector over an unintended active implanted device. Placing the patient connector over an unintended active implanted device could interfere with that device, potentially affecting its operation. 6. Follow the instructions in the app to complete the task.

3.3 Troubleshooting An error or an informational message displays in the app if there is a problem with the patient connector. The message may have an animated demo with directions on how to resolve the condition. Refer to the app online help for additional information about specific error codes. For some conditions, contact Medtronic using the information found on the back cover of this manual. 3.3.1 Patient connector battery status If the patient connector needs to be recharged, the following condition occurs: Condition Action The battery status light on the patient con- Recharge the patient connector battery. nector is amber.

Result When the patient connector is charging the battery status light flashes green. When the battery is fully charged the battery status light is solid green.

3.3.2 Patient connector position Position the patient connector correctly over the implantable device to communicate with it. If you do not position the patient connector properly over the implantable device, the following condition may occur: Condition The telemetry status light is amber.

The telemetry status light is off.

Action Result Reposition the patient connector over the When the telemetry status light turns implantable device. green, the patient connector is communiIf the implantable device is implanted in the cating with the implantable device. The patient, additional implanted devices may telemetry status light is brighter when the interfere with the communication between communication from the device is stronthe patient connector and the patient’s ger. implanted device. If the patient has more than one implanted device and you are unable to communicate with the patient’s implanted device, reposition the patient connector closer to the patient’s implanted device. Confirm that the implantable device is a When the telemetry status light turns Medtronic device. The patient connector green, the patient connector is communionly works with Medtronic implantable cating with the implantable device. The devices. telemetry status light is brighter when the Reposition the patient connector over the communication from the device is stronMedtronic implantable device. ger.

3.3.3 Bluetooth connection lost The patient connector pairs with a mobile device to send data. If the patient connector loses the Bluetooth connection with the mobile device, the following condition occurs: Condition Action Result The Bluetooth connection status indicator Check that Bluetooth is enabled on the The Bluetooth connection status light is on. light flashes. mobile device. Enable Bluetooth on the When the blue light is on, Bluetooth has mobile device if it is not enabled. established a connection between the Move the mobile device closer to the patient connector and the mobile device. patient connector and confirm that the blue light on the patient connector is on. Check 16

Condition

Action Result that nothing physical is blocking the signal between the patient connector and the mobile device.

4 Maintaining the patient connector 4.1 Cleaning and disinfecting the 24967 patient connector 4.1.1 Cautions and notes for cleaning and disinfecting Cautions: • Clean and disinfect the patient connector as needed according to your organization’s policies. Use only the recommended methods to clean and disinfect the patient connector. Depending on the level of contamination, such as exposure to blood or body fluid, Medtronic recommends cleaning and disinfecting the patient connector promptly after use to minimize drying and cross contamination. • Use only recommended cleaning and disinfecting methods on the patient connector. Using other cleaners, solvents, or disinfectants (such as bleach, ethers, acetone, or chlorinated solvents) may damage the patient connector plastic, circuitry, or metal components. • Do not immerse the patient connector in water or cleaning agents. Do not use automated machine washers. Severe damage to the patient connector may occur. • Do not sterilize the patient connector by ethylene oxide, gamma radiation or steam-sterilization (autoclave). Severe damage to the device, housing, or labels may occur using these methods. Notes: • The patient connector is designed to withstand normal cleaning and disinfecting over its product life. • The disinfecting procedure below has been tested and shown to achieve a log 4.8 or greater reduction in pathogens. If your organization or application requires a higher level of disinfection, place the patient connector inside a sterile barrier (such as the Medtronic Model 6177 sterile sleeve). • During procedures in a sterile environment or when cross contamination is a concern, place the patient connector inside a sterile barrier (such as the Medtronic Model 6177 sterile sleeve). • The power cord, USB cable, and optional tether kit accessories cannot be disinfected effectively. If these accessories become contaminated, discard the accessory and contact Medtronic for a replacement. When using the optional tether kit to secure the USB cable or power cord, place the patient connector inside of the Medtronic Model 6177 sterile sleeve to limit patient contact and reduce device exposure to contamination. 4.1.2 Preparing the patient connector 1. If the patient connector is connected plugged into a power source, unplug it. If you are using the optional tether kit to secure the cord to the patient connector, only unplug the cord from the power source.

2. The patient connector powers off automatically in 5 min when it is not connected to a power source. Wait 5 min for the patient connector to power off. The LED lights turn off when the patient connector powers off.

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3. Unwrap the blue weight from around the patient connector and fully extend the cord.

4.1.3 Cleaning the patient connector 1. Clean the patient connector thoroughly using one of the following cleaning methods: • A 70% isopropyl alcohol prep pad. • A sterile gauze pad or sponge dampened with 70% isopropyl alcohol. 2. Wipe all external surfaces of the patient connector to remove all visible soil. a. Wipe the blue weight and its cord.

b. Wipe all sides of the patent connector, including the cord retention channel and cable power supply connector cover or optional tether kit.

c. Wipe the top of the patient connector.

d. Wipe the bottom of the patient connector.

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e. If the optional tether kit is installed to secure the power supply cord or USB cable, wipe the cord or cable for approximately 1 m (3 feet) extending from the patient connector.

3. Allow to air dry approximately 5 minutes or until dry. Leave the blue weight fully extended until it is dry.

4.1.4 Disinfecting the patient connector 1. Follow the steps in the previous section to thoroughly clean all external surfaces of the patient connector. You do not need to allow the patient connector to dry if you are disinfecting it after cleaning. 2. If the optional tether kit is installed, remove the tether kit and unplug the USB cable or power cord. Reinstall the cable connector port cover to seal the connector port contacts. The USB cable, power cord, and optional tether kit accessories cannot be disinfected effectively. If these accessories become contaminated, remove them from the patient connector and discard. Contact Medtronic for a replacement. 3. Disinfect the patient connector with one of the following materials: • Several 70% isopropyl alcohol prep pads, or sterile gauze pads or paper wipes dampened with 70% isopropyl alcohol. • Several 1.4% hydrogen peroxide wipes. 4. Fully wrap all external surfaces of the patient connector with the damp prep pads, sterile gauze pads, or wipes. a. Wrap the blue weight and its cord lengthwise to completely cover both.

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b. Wrap all sides of the patient connector to completely cover it.

5. To maintain a wet or damp exposure time of 15 minutes and reduce evaporation, place all wrapped components of the patient connector inside a plastic bag or container. Seal the bag or container to reduce evaporation.

6. After 15 minutes have elapsed, remove all wrapped components of the patient connector from the plastic bag or container.

7. Remove the damp prep pads, paper wipes, or sterile gauze from the exterior of the patient connector and all its components.

8. Safely discard the damp prep pads, paper wipes, or sterile gauze according the policies and procedures of your organization. 9. Allow to air dry approximately 5 minutes or until dry. Leave the blue weight fully extended from its cord during drying.

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