A1-A, A1-B, A1-ABP, A1-MBP

A1 A1-A, A1-B, A1-ABP, A1-MBP IS-1 Configuration Lead Adapters Technical Manual Inside front cover A1 Adapters Technical Manual i Contents 1. Ge...
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A1 A1-A, A1-B, A1-ABP, A1-MBP IS-1 Configuration Lead Adapters

Technical Manual

Inside front cover

A1 Adapters Technical Manual i

Contents 1. General Description ............................................................1 2. Specifications......................................................................3 3. Important Notes...................................................................5 3.1 Sterilization and Storage .....................................................5 3.2 Opening the Sterile Container.............................................6 3.3 Package Content and Accessories .....................................6 3.4 Measurement of the Capture Threshold and Intracardiac Signals ............................................................7 4. Disclaimer and Warning .....................................................9 5. Operating Instructions .....................................................11

1997 BIOTRONIK, Inc., all rights reserved.

ii A1 Adapters Technical Manual

A1 Adapters Technical Manual 1

1. General Description The BIOTRONIK A1 adapters have been designed to facilitate the safe and fast connection of implanted leads to BIOTRONIK pacemakers having an IS-1* connector receptacle. The A1-A, A1-B, A1-ABP, and A1-MBP adapters consist of an IS-1 connector and a lead connector receptacle. A short insulated multifilar coiled conductor connects the IS-1 connector of the adapter to the lead receptacle end. The connection between the implanted lead and the adapter is accomplished by set screws and ligatures. Note that BIOTRONIK pulse generators are available with suitable connector receptacles for implanted leads having a Medtronic (5 mm) or Cordis (6 mm) size connector.

*

The IS-1 pacemaker/lead connection system has been approved as a standard by the ISO/IEC International Pacemaker Standards Working Group, as written in the standard ISO 5841-3: 1992(E). Non-BIOTRONIK pulse generators having 3.2 mm lead connector receptacles (header ports) which do not expressly claim to agree with the IS-1 dimensions generally have to be regarded as incompatible with IS-1 connectors and cannot be used with BIOTRONIK products.

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A1 Adapters Technical Manual 3

2. Specifications Designation

Connection System

(Catalog No.)

Pacemaker

Lead

A1-A (109 343)

UP (IS-1 unipolar)

A (5 mm)

A1-B (109 346)

UP (IS-1 unipolar)

B (6 mm)

A1-ABP (109 351)

BP (IS-1 bipolar)

ABP (5 mm, 2x)

A1-MBP (110 841)

BP (IS-1 bipolar) UP (IS-1 unipolar)

1)

2)

1)

3.2 mm “in-line” connector bipolar or unipolar

1)

e.g., Medtronic e.g., Cordis 3) “In-Line” connector (3.2 mm) without sealing rings (e.g., Medtronic) or with longer pin (e.g., Cordis) 2)

Specifications subject to modification, revision and improvement. Please contact your BIOTRONIK representative for availability.

3)

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A1 Adapters Technical Manual 5

3. Important Notes 3.1 Sterilization and Storage The adapter is shipped in an outer box, equipped with a quality control seal and product information label. The label contains the model specifications, technical data, serial number, expiration date, adapter sterilization and storage information. The adapter and its accessories have been sealed in a double plastic container and gas sterilized with ethylene oxide. To assure sterility, the container should be checked for integrity prior to opening. Should a breach of sterility be suspected, the adapter should be placed in its packaging and returned to BIOTRONIK.

C AUTION Recommended storage temperature range is 5°− 55° C (41°−131° F). Exposure to temperatures outside this range may result in adapter malfunction.

Should a replacement adapter be needed, contact your local BIOTRONIK representative.

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3.2 Opening the Sterile Container The adapter is packaged in two plastic containers, one within the other. Each is individually sealed and then sterilized with ethylene oxide. Due to the double packaging, the outside of the inner container is sterile and can be removed using standard aseptic technique and placed on the sterile field.

ST_01

Peel off the sealing paper of the outer unsterile container as indicated by the arrow.

Take out the inner sterile container by the gripping tab and open it by peeling the sealing paper as indicated by the arrow.

3.3 Package Content and Accessories All adapters are delivered sterile with medical adhesive and a hex torque wrench.

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3.4 Measurement of the Capture Threshold and Intracardiac Signals An implanted pacing lead provides a direct, low resistance path for electrical current from the implanted pulse generator to the myocardium. Pulse generators and testing equipment connected to the lead must be battery-powered. Proper grounding of line-powered devices in the vicinity of the patient is essential to prevent leakage currents arising from such devices from being conducted through the lead terminal or any other uninsulated part. The BIOTRONIK ERA 20 or ERA 300 Pacing System Analyzer (PSA) may be used to accurately determine current and voltage capture thresholds, as well as intracardiac signals in accordance with the characteristics of the implanted pacing devices. It is preferable that the filter characteristics of the input circuits of the pacemaker and the measurement device are the same, particularly for correlating measured intracardiac signal with the sensitivity of the pacemaker to be implanted. For measuring the capture threshold, the pacing rate should be higher than the patient’s intrinsic rate. The lowest voltage or current required to capture the heart represents the capture threshold with respect to the established pulse width. Pacing may be interrupted during the measurement of the intracardiac signal, depending upon the Pacing System Analyzer used; its measured value will be digitally displayed by the pertinent BIOTRONIK devices. Generally, the electrode position is regarded acceptable if the values for capture threshold are not exceeded and those for sensing are not below the following units. Atrial

Ventricular

Maximum acute capture threshold at pulse duration setting 0.5 ms

1.5 V

1.0 V

Minimum acute sensing amplitudes

3 mV

5 mV

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A1 Adapters Technical Manual 9

4. Disclaimer and Warning Pacemakers, leads, lead extensions and adapters are implanted in the extremely hostile environment of the human body. Upon implantation they become part of the interdependent pacing system which includes the physiological conditions determining its function. The pacing system may cease to function at any time due to medical complications as well as lead-related problems, including but not limited to displacement, wire fracture, loss of insulation integrity, fibrotic tissue formation and elevated thresholds. Possible side effects of lead adapter implantation include, but are not limited to, body rejection phenomena, thrombosis, muscle and nerve stimulation, infection and erosion through skin. BIOTRONIK leads, lead extensions, adapters and accessories used in connection with these devices (referred to as: leads and accessories) have been qualified, manufactured and tested in accordance with well proven and accepted standards and procedures. The physician should be aware, however, that leads and accessories may easily be damaged by improper handling or use. Whatsoever the cause for a failure, there is no warranty, express or implied, for leads and accessories. Leads and accessories are sold in an “as is” condition. The entire risk as to the quality and performance of leads and accessories is with the buyer. BIOTRONIK disclaims all warranties, express or implied, with respect to leads and accessories including but not limited to, any implied warranty of merchantability or fitness of a particular purpose. BIOTRONIK or its distributor shall not be liable for any loss, damage or injury of any nature, whether direct, indirect, or consequential in connection with, or resulting from, the use of leads and accessories. No person is authorized to bind BIOTRONIK or its distributor to any representation or warranty with respect to its leads or accessories.

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A1 Adapters Technical Manual 11

5. Operating Instructions Check to make sure that the adapter is compatible with the connector of the implanted lead and the connector receptacle of the BIOTRONIK pulse generator (refer to page 3). Unscrew setscrew of the adapter receptacle if necessary, so that it does not protrude into bore-hole of the adapter receptacle. When using the A1-ABP adapter, make sure that the polarity is correct. The adapter receptacle marked with a white ring must be connected to the different lead connector for the distal (–) electrode. Bipolar BIOTRONIK leads with bifurcated connector pins also have the different pole marked with a white ring. The inside of the A1-MBP adapter includes sealing rings for reliable insulation of “In-Line” connectors which have no sealing rings. The A1-MBP adapter may be used for connection of unipolar as well as bipolar leads to the respective pacemaker with an IS-1 connector receptacle. When connecting unipolar leads, care must be taken to avoid damaging the silicone insulation of the unipolar connector by turning the distal setscrew in the adapter receptacle. Also, for unipolar leads, both screw openings must be sealed with medical adhesive.

Observing the usual safety precautions, disconnect the pulse generator, clean the lead connector(s), lubricate it with silicone oil and insert it into the adapter receptacle.

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Tighten the setscrew(s) in the adapter receptacle clockwise with the hex torque wrench until reaching the limit of the torque transmission.

Seal screw hole(s) with medical adhesive.

Seal distal part of the adapter receptacle(s) by applying nonabsorbable ligature(s).

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Lubricate the IS-1 connector of the adapter with one drop of silicone oil and insert it into the header of the pulse generator without bending the lead. Tighten setscrew(s) in the pulse generator and seal with screw cap(s), if applicable. When connecting a unipolar adapter with an IS-1 connector pin, care must be taken that the connector pin is fully inserted into the pacemaker receptacle, and is kept in that position until the setscrew has been tightened securely. The dimensions of the connector pin and the corresponding pacemaker receptacle are specified in the IS-1 standard. The two pairs of sealing rings lie at locations with different diameters so that air is compressed when advancing the connector pin. This can possibly result in a recoil effect, pushing the pin out of the contact area. When tightening the setscrew, verify proper insertion of the connector pin by assuring that the tip of the pin is visible beyond the screw block, as illustrated. After tightening the setscrew, the safety of the connection should be checked visually and mechanically.

Inside back cover

Distributed by:

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 (24-hour) (503) 635-9936 (FAX) Manufactured by:

M3029-E 9/97

BIOTRONIK GmbH & Co. Woermannkehre 1 D-12359 Berlin Germany