CareLink SmartSync Device Manager - Pacing System Analyzer

K163008 · Medtronic, Inc. · DTA · Feb 28, 2017 · Cardiovascular

Device Facts

• Record ID: K163008
• Device Name: CareLink SmartSync Device Manager - Pacing System Analyzer
• Applicant: Medtronic, Inc.
• Product Code: DTA · Cardiovascular
• Decision Date: Feb 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3720
• Device Class: Class 2

Indications for Use

The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base's ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

Device Story

CareLink SmartSync Device Manager is a microprocessor-based pacing system analyzer (PSA) used during cardiac device implantation or invasive troubleshooting. The system consists of a hardware base (Model 24970A) and software applications running on a non-medical mobile platform (tablet). The base connects to cardiac leads via surgical/patient cables and to surface electrodes via ECG cables. It digitizes input signals and communicates via Bluetooth to the mobile app. The app provides the user interface for clinicians to perform lead impedance measurements, assess lead placement, view/record live EGM and ECG waveforms, and conduct pacing threshold tests. The system supports dual and single chamber pacing modes and rapid atrial stimulation. Clinicians use the displayed data to assess lead performance and guide clinical decision-making during procedures. The device benefits patients by ensuring proper lead function and placement during cardiac device implantation.

Clinical Evidence

No clinical data or animal studies were performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software verification and validation, and mechanical robustness testing.

Technological Characteristics

Microprocessor-based PSA hardware (Model 24970A) with mixed-signal ICs for signal digitization. Materials include polycarbonate (SABIC LEXAN EXL-9330) and thermoplastic elastomer. Connectivity via Bluetooth (2.1/4.0) and Conexus telemetry (402-405 MHz). Powered by 5V DC or AA alkaline batteries. Dimensions: 1.8" x 9.45" x 8.2". IP2X ingress protection. Software is major level of concern. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for use by healthcare professionals in operating environments under direct medical supervision to analyze cardiac lead electrical performance during device implant or invasive troubleshooting, and to view, measure, and record live cardiac waveforms.

Regulatory Classification

Identification

A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.

Predicate Devices

• Medtronic Model 2290 Lead Analyzer (P890003/S065)
• Medtronic Model 5311B A-V Pacing System Analyzer (K910595)

Reference Devices

• Medtronic Model 24967 patient connector (K163460)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### February 28, 2017

Medtronic, Inc. Laura Danielson Principal Regulatory Affairs Specialist 8200 Coral Sea Street Ne Mounds View, Minnesota 55112

Re: K163008

Trade/Device Name: Carelink SmartSync Device Manager Pacing System Analyzer Regulation Number: 21 CFR 870.3605 Regulation Name: Pacing System Analyzer Regulatory Class: Class II Product Code: DTA, DTE Dated: January 25, 2017 Received: January 26, 2017

Dear Laura Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Sincerely,

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K163008

#### Device Name

Carelink SmartSync Device Manager Pacing System Analyzer

Indications for Use (Describe)

The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base's ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

Type of Use (Select one or both, as applicable)

| <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

| Date Prepared: | January 13, 2017 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 510(k) Owner / Address: | Medtronic, Inc.<br>Cardiac Rhythm and Heart Failure<br>8200 Coral Sea Street<br>Mounds View, MN 55112 |
| Contact: | Laura L. Danielson<br>Principal Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Trade / Proprietary Name: | CareLink SmartSync™ Device Manager<br>Pacing System Analyzer |
| Common Name: | Pacing System Analyzer |
| Classification /<br>Classification Name: | Class II<br>Pacing System Analyzer<br>(21 CFR 870.3605) |
| Product Code: | DTA, DTE |

# Predicate Devices

The intended use, design, materials and performance of the CareLink SmartSync™ Device Manager Pacing System Analyzer with associated Applications (Models: D00U001, D00U002, M01G02, M01A02, M01G01, and M01A01), cables (previously approved) and accessories are substantially equivalent to the following predicate device:

- Medtronic Model 2290 Lead Analyzer approved on 13MAR2002 P890003/S065. ●
- . Medtronic Model 5311B A-V Pacing System Analyzer cleared on 07MAY1991 K910595.

# Device Description

#### Device Identification:

The following is a list all key device components included in the submission:

- . CareLink SmartSync Device Manager base (PSA hardware), Model 24970A
- . CareLink SmartSync PSA App, Model D00U002
- CareLink SmartSync Host, Model D00U001

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- . CareLink SmartSync Common Application, Model M01G02 (Android) and Model M01A02 ( iOS )
- . CareLink SmartSync Platform, Model M01G01 (Android) and Model M01A01 (iOS)
- . Non-Medical Mobile Platform (i.e. Tablet)

The following compatible accessories are available for the CareLink SmartSync Device Manager base (PSA hardware) that Medtronic is seeking clearance for in this 510(k) submission:

- . ME20A054F03 power supply (Medtronic re-order number: 249701), 1.8 m (approximately 6 ft.): a floor mount that connects through the 249705 AC power cord to the wall on one end, and through a DC power cord to the base station on the other end with a right angle barrel plug
- . 249705 AC power cord, 1.8 m (approximately 6 ft.): Connects the power supply to AC power
- 249702 USB cable, approximately 3 m (10 ft.): connects to the Model 24967 patient . connector (not the subject of this submission. but in another 510(k) but only upon approval of both models)
- . 249672 Tether Kit: Secures the USB cable 249702 and Power supply 24951 to the Model 24967 patient connector (Not the subject of this 510(k) submission). Contains an Allen wrench, screw, and cable retainer
- . 249703 Wall mount: mounts the base to the wall when table space is a concern

The above listed accessories are considered off the shelf and non-medical.

The following compatible cables and adaptors are available for the base. These are the same adaptors and cables used with the current market approved and released Model 2290 PSA predicate and are considered medical devices.

Surgical and patient cables connect the base to cardiac leads for lead analysis. Adaptors allow surgical and patient cables to be connected to the base when their plugs are not compatible with the Type CF connection port on the base. Ground cables connect to the base (via alligator clip connecting to a cable) and complete the electrical circuit when connected to unipolar implantable cardiac device leads.

- 2292 Surgical cable, 3.66 m (12 ft.) – Approved: P890003/S065, 13MAR2002
- 5103 A/V adaptor Approved: P890003/S054, 24SEPT1998 ●
- 5104 Analyzer Adaptor - Approved: P890003/S054, 24SEPT1998
- 5114 Adaptor - Approved P890003 (initial submission), 24AUG1989
- 5832 Surgical cable, approximately 3.5 m (12 ft.) P890003/S070, 31OCT1995 ●
- 5833S Surgical cable, 1.83 m (6 ft.) Cleared: K923407, 190CT1992 ●
- 5833SL Surgical cable, 3.66 m (12 ft.) Cleared: K923407, 19OCT1992 .
- 5473 Ground cable Cleared: K961520, 13NOV1996 ●
- 5436 Analyzer patient cable, 3.66 m (12 ft.) - Approved: P890003/S054, 24SEPT1998

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The following compatible ECG interface cables, and adaptors are available for the base. These are the same Adaptors and Cables used with the current market approved and released Model 2290 PSA predicate and are considered medical devices.

ECG cables and leads connect the base to surface electrodes on the patient for the display of live waveforms. Adaptors allow ECG monitors with phono connectors to be connected to the base.

- 5437 ECG Interface cable, 6.4 m (20 ft.) Approved: P890003/S065, 13MAR2002 ●
- 5437A Adaptor Approved: P890003/S065, 13MAR2002 .
- . 2090EC ECG cable, approximately 2.6 m (103 in.) - Approved: P890003/S065. 13MAR2002
- 2090ECL ECG cable, approximately 5.5 m (215 in.) - Approved: P890003/S065, 13MAR2002
- 9790LA ECG leads, approximately 1 m (40 in.) Approved: P890003/S027, ● 29NOV1994
- . 9790XLA ECG leads, approximately 1 m (40 in.) = Approved: P890003/S027, 29NOV1994

Medtronic recommends the use of Medtronic-supplied components only. Use of unapproved components may reduce device effectiveness or impact user or patient safety.

### Device Characteristics:

The CareLink SmartSync PSA is comprised of Base, software applications, associated cables and power cords. The software applications reside on a mobile platform or tablet and pair via Bluetooth® with the base hardware. The mobile platform is considered non-medical. The Operating System is also non-medical software that is delivered with and resides on the Mobile Platform.

The CareLink SmartSync Device Manager base (Model 24970A) is not considered a single-use device.

The CareLink SmartSync Device Manager base (Model 24970A) is not provided sterile.

### Environment of Use:

The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

### Brief Written Description of the Device:

The CareLink SmartSync Device Manager system (referred to from now on as the device manager system) is comprised of the Model 24970A Base and CareLink SmartSync Device Manager app installed and running on your mobile device.

The CareLink SmartSync Device Manager Base (referred to from now on as the base) pairs with the Medtronic CareLink SmartSync Device Manager app on your mobile device to analyze the cardiac lead system for an implantable Medtronic device. The base includes these features:

- Analyzer hardware and patient cable connections to support electrical assessment of ● cardiac leads during implant.

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- . ECG cable connections to collect live cardiac waveform data that can be viewed, measured, and recorded using the app running on your mobile device.
- Bluetooth® wireless technology to communicate with the app running on your mobile . device.1

The Model 24970A Base contains a microprocessor that maintains the pacing engine logic function for the PSA.

The PSA hardware within the Base consists of two main integrated circuits (ICs) which provide a variety of functions as listed below:

- . Micro Controller Unit: the microprocessor is used to provide timing support and also onboard memory for the device.
- Mixed Signal Integrated Circuit: the mixed signal IC chip takes the input signals from the . cables (connected to a lead) and digitizes it for use by the device. This IC is also responsible for the electrogram (EGM) waveform and power management.

The App is the primary user interface for the device manager system. The App for the CareLink SmartSync PSA is comprised of four main components:

- . A Host Application component that provides the system user interface necessary to initialize, and set-up the CareLink SmartSync Device Manager and launch the PSA Clinician Application
- . a Platform Application component for the transfer/exchange, storage/retrieval, electronic conversion, and electronic display of medical device data
- a Common Application component that is a collection of software components that are . utilized by the PSA or Device Applications
- . a PSA Application component that is a Mobile Platform Application that allows user to use the PSA device

The App includes these features:

- Bluetooth® connectivity to pair with the base. .
- Integration with the base to start a lead analysis session.
- . Mobile device connectivity tools for sharing and printing Analyzer reports.
- . Updates to app software using an Internet connection.

The Analyzer tools in the App form the primary user interface to the Base). These tools display and report on the cardiac lead and ECG data transmitted from the base. Clinicians use this data to perform these tasks:

- Analyze electrical performance of cardiac leads during implant. ●
- . Assess proper placement of cardiac leads during implant.
- . View, measure, and document live cardiac waveforms.

CareLink SmartSync Application Models installed on a clinician's off-the-shelf non-medical mobile device. The Operating System is also non-medical software that is delivered with and resides on the non-medical Mobile Platform.

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The Analyzer has the following features:

- Dual and single chamber pacing modes.
- . Automatic measurement of P-wave and R-wave amplitudes.
- Lead impedance measurement. ●
- Real-time display of atrial and ventricular EGM and ECG waveforms.
- Rapid atrial stimulation to 850 min-1 (ppm).
- Advanced pulse width versus amplitude pacing threshold tests.
- Measurement reports.

The CareLink SmartSync Device Manager provides the essential capabilities for analysis of and the electrical performance of cardiac leads during device implant in a hospital environment (See Tables 1 through Table 4).

Table 1: PSA Base Physical Characteristics

| Parameter | Value |
|----------------------------|----------------------------------------------------------------------------------------------------------------------|
| Footprint | 548 cm² |
| Mass | 0.91 kg (2.0 lbs.) |
| Dimensions H x W x D | 1.8 in x 9.45 in x 8.2 in |
| Device identification code | Device serial number prefix<br>"SPM" |
| Power Source | 5V Direct Current provided by<br>Medical Grade External Power<br>Supply. PSA Battery info in the<br>following table. |

#### Table 2: PSA Base (off the shelf) AA Battery Characteristics

| Parameter | Value |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Manufacturer | Panasonic |
| Model/type | IEC LR6 Alkaline Battery (AA)<br>(n=2) per Base |
| Chemistry | Alkaline |
| Battery Life dependence upon utilization<br>monitored by the Mobile Application on the<br>user mobile device. | 2 years required replacement as<br>indicated by the Maintenance<br>schedule |

| Parameter | Description | Fixed Value |
|------------------------|-------------------------------------------------------------------------|---------------------|
| ECG Gain | Surface ECG User Interface display | 1.0 |
| Sampling<br>Rate | Rate at which the ECG signal is digitized | 500 Hz |
| Sampling<br>Resolution | Number of bits per sample used in the digitization<br>of the ECG signal | 16 bits /<br>sample |

#### Table 3: PSA Base ECG Signal Characteristics

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| Parameter | Description | Fixed Value |
|-----------------------|-------------------------------------------------------------------------|-----------------|
| EGM Gain, Atrial | Amplification of the atrial EGM signal | 75X |
| EGM Gain, Ventricular | Amplification of the ventricular EGM signal | 18.75X |
| High Pass Pole | -3dB high pass filter frequency | 2.0Hz to 3.0Hz |
| Low Pass Pole | -3dB low pass filter frequency | 80Hz to 110Hz |
| Sampling Rate | Rate at which the EGM signal is digitized | 256 Hz |
| Sampling Resolution | Number of bits per sample used in the<br>digitization of the EGM signal | 8 bits / sample |

### Table 4: PSA Base EGM Signal Characteristics

# Materials of Use

The following is a list of exposed materials included in the manufacture of the Model 24970A:

| Component | Material |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Top Enclosure Base | Plastic:<br>SABIC LEXAN EXL-9330 Polycarbonate<br>White Resin per Medtronic color chip M954239A001<br>Elastomer Edge:<br>Eraprene A6060N-SP<br>Thermoplastic Elastomer<br>Blue per Pantone 301 |
| Lid Base | Plastic:<br>SABIC LEXAN EXL-9330 Polycarbonate<br>White Resin per Medtronic color chip M954239A001<br>Graphics:<br>Pantone 301 Blue<br>Elastomer Edge:<br>Eraprene A6060N-SP<br>Thermoplastic Elastomer<br>Blue per Pantone 301 |
| Bottom Enclosure Base | Plastic:<br>SABIC LEXAN EXL-9330 Polycarbonate<br>White Resin per Medtronic color chip M954239A001<br>Graphics:<br>Pantone 301 Blue |
| Membrane Keypad Base | Graphics:<br>Autotex-2(V200)<br>Polyester<br>Button:<br>Silicone Rubber<br>60 Shore A<br>Clear<br>Top Coat:<br>Polyurethane<br>Per color chip Pantone Cool Grey 8 |

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| Component | Material |
|--------------------|----------------------------------------------------------------------------------------|
| Battery Cover Base | SABIC LEXAN EXL-9330 Polycarbonate<br>White Resin per Medtronic color chip M954239A001 |
| Foot Rear Base | Silicone Rubber 70 Shore A<br>Color: Pantone Cool Grey 8 |
| Device Label Base | Lexan PC 8B35<br>Polycarbonate<br>Clear |
| QR Code Label Base | Lexan PC 8B35<br>Polycarbonate<br>Clear |
| PSA Connector Base | Hypertronics D02 Housing<br>Polyethermide<br>Black |

The device does not include biologics, drugs, or coating additives. The pacing system analyzer is not intended for patient contact.

# Key Performance Specifications/Characteristics of the Device

#### Base Specifications

| Standards (The base complies with the following:) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Radio frequency wireless specifications and applicable standards | |
| EMC | EN / IEC 60601-1-2<br>EN 300 328<br>EN 301 489<br>EN 302 195<br>EN 301 839<br>EN 55011 Class A |
| Radio | FCC CFR 47 |
| Patient safety | UL/CUL 60601-1, Type BF applied part, Type CF applied parta<br>EN 60601-1, Class 2, continuous operation, Type BF, Type CFa |
| AC power requirement | |
| Voltage | 100-240 VAC nominal |
| Frequency | 50/60 Hz nominal |
| Battery | |
| Type | AA Alkaline (LR6) or Lithium-ion, non-rechargeable (quantity of 2) |
| Voltage | 1.5 V each |
| Base Electrical Specifications | |
| Power Supply | |
| Model | ME20A0540F03 power supply (Medtronic re-order number 249701) |
| Voltage in | 100-240 VAC 0.5A at 50-60 Hz |
| Voltage out | 5 VDC 3 A |
| USB Cable | |
| Model | 249702 USB cable |
| Voltage | 5 V 0.8 A |
| Power | 4 W |
| Charge cradle | |
| Model | 24970A |
| Voltage | 5 V 0.8 A |
| Power | 4 W |
| IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) | |
| Ingress | This product complies with international electrical safety rating<br>IP2X with regard to ingress of dust, other foreign objects, and<br>water as required by IEC 60601-1. |
| Physical dimension and weight | |
| Height | 4.6 cm (1.8in) |
| Width | 24 cm (9.5 in) |
| Depth | 20.8 cm (8.2 in) |
| Weight | 0.91 kg (2 lbs) |
| Temperature Limits | |
| Operating | 10°C to 35°C (50°F to 95°F) |
| Storage | 15°C to 30°C (59°F to 86°F) |
| Transport | - 30°C to 55°C (-22°F to 131°F) |
| Humidity Limits | |
| Operating | 8%-80% |
| Storage | 15%-93% at 35°C (95°F) |
| Transport | 15%-93% at 35°C (95°F) |
| Altitude | |
| Maximum | 3000 m |
| Connectivity | |
| Conexus wireless telemetry | |
| Frequency range | 402-405 MHz |
| Modulation frequency | Frequency shift key |
| Output power | 25 µW EIRP max |
| Bluetooth 2.1 and 4.0 | |
| Frequency range | 2.4-2.483 GHz |
| Modulation frequency | Gaussian frequency shift key |
| Output power | Less than 10 mW EIRP |
| * The ECG cable (Type BF), 24967 Patient Connector (Type BF) and patient or surgical cable (Type CF) are the only accessories<br>that come into direct contact with the patient. The base itself is not intended to come into contact with the patient during normal<br>use. | |
| Expected Service Life: | 5 years |
| Disposal of the base: Return the base to Medtronic for proper disposal. Contact Medtronic at the address or telephone number on<br>the back cover for information on returning the base. | |
| Electromagnetic compatibility declaration | |
| The following list of accessories is compliant with the requirements of IEC 60601-1-2. | |
| Accessory | Maximum length |
| | |
| ME20A0540F03 Power supply | 1.8 m (6 ft) |
| 249705 AC power cord | 1.8 m (6 ft) |
| 249702 USB cable | 3 m (10 ft) |
| 24967 Patient Connector | N/A |
| 2292 Surgical cable | 3.66 m (12 ft) |
| 5832 Surgical cable | 3.5 m (12 ft) |
| 5833S Surgical cable | 1.83 m (6 ft) |
| 5833SL Surgical cable | 3.66 m (12 ft) |
| 5346 Analyzer patient cable | 3.66 m (12 ft) |
| 5437 ECG Interface cable | 6.4 m (20 ft) |
| 2090EC EKG cable | 2.6 m (103 in) |
| 2090ECL EKG cable | 5.5 m (215 in) |
| 9790LA EKG leads | 1 m (40 in) |
| 9790XLA EKG leads | 1 m (40 in) |

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Use of accessories other than what is specifically listed may result in increased immunity of the 24970A base.

The 24970A base needs special precautions regarding electromagnetic compatibility (EMC) and used according to the EMC information provided in the accompanying documents.

The 24970A base should not be used adjacent to or stacked with other equipment that is not part of the device manager system (base, mobile device, and accompanying accessories). If adjacent or stacked use is necessary, the 24970A base should be observed to verify normal operation in the configuration in which it will be used.

The 24970A base contains RF transmission and receiving capabilities. Consequently, it is possible that other equipment may interfere with the 24970A base even if that other equipment complies with CISPR emission requirements. The following is a technical summary of the RF communication properties:

Transmitting and receiving:

- Technology type: Conexus wireless telemetry, Bluetooth wireless technology
- Frequency of operation: 402 MHz to 405 MHz, 2.4 GHz to 2.483 GHz
- Modulation characteristics: Frequency shift key, Gaussian frequency shift key
- Field strength: 25 µW EIRP max, less than 10 mW EIRP ●

#### Guidance and manufacturer's declaration-electromagnetic emissions

The 24970A base is intended for use in the electromagnetic environment specified below. The user of the 24970A base should assure that it is used in such an environment.

| Emissions test | Compliance | Electromagnetic environment-guidance |
|------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| RF emissions<br>CISPR 11 | Group 1 | The 24970A base uses RF energy only for its internal function.<br>Therefore, its RF emissions are very low and are not likely to<br>cause any interference in nearby electronic equipment. |
| RF emissions<br>CISPR 11 | Class A | |
| Harmonic emissions<br>IEC 61000-3-2 | Class A | The 24970A base is suitable for use in all establishments other<br>than domestic, and may be used in domestic establishments and<br>those directly connected to the public low-voltage power supply<br>network that supplied buildings used for domestic purposes,<br>provided the following warning is heeded: |
| Voltage fluctuations/flicker<br>emissions<br>IEC 61000-3-3 | Complies | Warning: This equipment/system is intended for use by<br>healthcare professionals only. This equipment/system may cause<br>radio interference or may disrupt the operation of nearby<br>equipment. It may be necessary to take mitigation measures, such<br>as re-orienting or relocating the 24970A base or shielding the<br>location. |
| Guidance and manufacturer's declaration-electromagnetic immunity | | |

The 24970A base is intended for use in the electromagnetic environment specified below. The user of the 24970A base should assure that it is used in such an environment.

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| Immunity test | IEC 60601 Test level | Compliance level | Electromagnetic<br>environment—guidance |
|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrostatic discharge<br>(ESD)<br>IEC 61000-4-2 | ±6 kV contact<br>±8 kV air | ±8 kV contact<br>±15 kV air | Floors should be wood,<br>concrete, or ceramic tile. If<br>floors are covered with<br>synthetic material, the relative<br>humidity should be at least<br>30%. |
| Electrical fast transient/burst<br>IEC 61000-4-4 | ±2 kV for power supply lines<br>±1 kV for input/ output lines | ±2 kV for power supply lines<br>±1 kV for input/ output lines | Mains power quality should be<br>that of a typical commercial or<br>hospital environment. |
| Surge<br>IEC 61000-4-5 | ±1 kV differential Mode<br>±2 kV common mode | ±1 kV differential Mode<br>±2 kV common mode | Mains power quality should be<br>that of a typical commercial or<br>hospital environment. |
| Voltage dips, short<br>interruptions, and voltage<br>variations on power supply<br>input lines<br>IEC 61000-4-11 | <5% UT (>95% dip in UT)<br>for 0.5 cycle<br>40% UT (60% dip in UT) for<br>5 cycles<br>70% UT (30% dip in UT) for<br>25 cycles<br><5% UT (>95% dip in UT)<br>for 5 s | <5% UT (>95% dip in UT)<br>for 0.5 cycle<br>40% UT (60% dip in UT) for<br>5 cycles<br>70% UT (30% dip in UT) for<br>25 cycles<br><5% UT (>95% dip in UT)<br>for 5 s | Mains power quality should be<br>that of a typical commercial or<br>hospital environment. If the<br>user of the 24970A base<br>requires continued operation<br>during power mains<br>interruptions, it is<br>recommended that the 24970A<br>base be powered from an<br>uninterruptible power supply or<br>a battery. Note: UT is the AC<br>mains voltage prior to<br>application of the test level. |
| Power frequency (50/60 Hz)<br>magnetic Field<br>IEC 61000-4-8 | 3 A/m | 3 A/m | Power frequency magnetic<br>fields should be at levels<br>characteristic of a typical<br>location in a typical<br>commercial or hospital<br>environment. |
| Conducted RF<br>IEC 61000-4-6 | 3 VRMS (volts root-<br>meansquare)<br>150 kHz to 80 MHz | 10 V | Portable and mobile RF<br>communications equipment<br>should be used no closer to any<br>part of the 24970A base,<br>including cables, than the<br>recommended separation<br>distance calculated from the<br>equation applicable to the<br>frequency of the transmitter.<br>Recommended separation<br>distance<br>$d = 0.35 \sqrt{P}$ |
| Radiated RF | 3 V/m | 10 V/m | d = 0.35 VP for 80 MHz to 800 |
| IEC 61000-4-3 | 80 MHz to 2.5 GHz | | MHz |
| | | | d = 0.70VP for 800 MHz to 2.5 |
| | | | GHz |
| | | | where P is the maximum |
| | | | output power rating of the |
| | | | transmitter in watts (W) |
| | | | according to the transmitter |
| | | | manufacturer and d is the |
| | | | recommended separation |
| | | | distance in meters (m). |
| | | | Field strengths from fixed RF |
| | | | transmitters, as determined by |
| | | | an electromagnetic site survey,4 |
| | | | should be less than the |
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