AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE

K961362 · Aerotel, Ltd. · DXH · Jul 10, 1996 · Cardiovascular

Device Facts

• Record ID: K961362
• Device Name: AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE
• Applicant: Aerotel, Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Indications for Use

The Telelink is a battery powered device intended to be used by the physician in his office, for the transfer of an ECG signal received over the telephone from a compatible transmitter, to a conventional single trace ECG recorder in the physician's office. The patient has no contact with the Telelink, and it does not affect him in any way.

Device Story

Battery-powered interface; receives ECG signals via telephone handset using acoustic coupler; converts signals to analog format; outputs to physician's conventional single-trace ECG recorder via patient cable. Used in physician offices by physicians or ECG technicians. Enables remote ECG transmission from compatible Aerotel transmitters (HeartView, H1001, H2002) to office-based recording equipment. Facilitates clinical review of transmitted ECG data; provides diagnostic utility equivalent to standard receiving consoles.

Clinical Evidence

Clinical testing involved 3 volunteers transmitting 3 and 12-lead ECGs via Aerotel HeartView. Signals were processed through Telelink and recorded on standard ECG recorders (MICRORULER, CARDIETTE, Elettronica Trentina). Results compared against the predicate H3000 console. ECGs from both systems were found equivalent in quality and diagnostic utility.

Technological Characteristics

Battery-powered interface; acoustic coupler for telephone handset connection; analog signal conversion; 3-wire patient cable interface for ECG recorders. No software operation; no memory storage. Bench tests performed: frequency response, temperature stress, electromagnetic immunity, and shock. No patient leakage current due to battery operation and lack of direct patient contact.

Indications for Use

Indicated for use by physicians or ECG technicians to facilitate the transfer of transtelephonic ECG signals to a conventional single-trace ECG recorder for clinical review.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• Aerotel H3000 transtelephonic ECG receiving console (K930314)

Reference Devices

• HeartView (K950004)
• H1001 (K931020)
• H2002 (K915624)
• MICRORULER (ECG recorder)
• CARDIETTE (ECG recorder)
• Elettronica Trentina (ECG recorder)

Submission Summary (Full Text)

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Aerotel
510(k)
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K961362
JUL 10 1996

# 510 (K) Submission
## Telelink telephonic ECG receiving interface

### 510(K) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements: Regulation par. 807.92, effective March 14, 1995.

1. **Submitter**
- Name: Aerotel Ltd.
- Address: 5, Hazoref St., Holon 58856, Israel.
- Telephone No.: [phone]
- Contact Person: Dr. George Myers, 201-438-2310
- Date prepared: January 25, 1996

2. **Device**
- Proprietary name: Telelink
- Common name: ECG telephonic receiving interface.
- Classification name: Transmitters and receivers electrocardiograph, telephone.

The Telelink is a battery powered ECG telephone receiving interface that is capable of transferring the transtelephonic ECG, received over the telephone, to a conventional single trace ECG recorder.

3. **Predicate device**
Aerotel H3000 transtelephonic ECG receiving console, 510(K): #K930314

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# Telelink

## 4. Description:

The Telelink is a battery powered interface which is intended to be used by a physician or an ECG technician to convert an ECG signal received via the telephone to an analog ECG signal recordable on the physician's conventional single trace ECG recorder.

The ECG signal can be sent over the phone by any of Aerotel's transtelephonic recorders/transmitters such as:
HeartView (510(K) # K950004)
H1001 (510(K) # K931020)
H2002 (510(K) # K915624)

or equivalent. These units have been cleared for sale in the United States by the FDA.

The Telelink has two connections; one of these is connected to the telephone's handset via an acoustic coupler (included) which is placed on the speaker of the handset; the other connection is attached to the single-trace ECG recorder in the physician's office via the recorder's patient cable by using only 3 wires of the patient cable.

After activating the recorder, all received ECG leads from the telephone, will be routed to the recorder which will print them out, one after the other, in the sequence in which they have been transmitted.

## 5. Intended use

The Telelink is a battery powered device intended to be used by the physician in his office, for the transfer of an ECG signal received over the telephone from a compatible transmitter, to a conventional single trace ECG recorder in the physician's office. The patient has no contact with the Telelink, and it does not affect him in any way.

## 6. Comparison

The Telelink has the same intended use as Aerotel's Heartline Receiving Console (510(K) # K930314). Its realization differs in that the Telelink does not have memory, is not PC-based, records on a conventional electrocardiograph, and is not software operated.

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# Telelink

## Performance Data

(a) Non clinical tests

Non clinical tests provided include bench tests of frequency response, temperature stress, electromagnetic immunity and shock tests. There is no leakage current issue because the device is battery operated, and not connected to a patient.

(b) Clinical tests

Electrocardiograms were taken from three volunteers transmitting over the phone 3 and 12 lead ECG (by Aerotel HeartView recorder / transmitter 510(K) # K950004) and printing them out on an ECG recorder model MICRORULER, CARDIETTE, Elettronica Trentina. The electrocardiograms were compared to those received on Aerotel's Heartline receiving console (510(K) # K930314) - the predicate device. The electrocardiograms from the two systems are equivalent in quality and diagnostic utility.

(c) Conclusion

The conclusion drawn from these tests is that the Telelink is equivalent in safety and efficacy to its predicate device.

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Photograph