5433xx Patient Cable Technical Manual

2 Package contents Model 5433A – Patient cable (atrial, short) • 1 cable, 1.83 m (6 ft) • Product documentation Model 5433AL – Patient cable (atrial, long) • 1 cable, 3.66 m (12 ft) • Product documentation Model 5433V – Patient cable (ventricular, short) • 1 cable, 1.83 m (6 ft) • Product documentation Model 5433VL – Patient cable (ventricular, long) • 1 cable, 3.66 m (12 ft) • Product documentation

3 Intended use The Medtronic Model 5433A, 5433AL, 5433V, and 5433VL reusable patient cables are intended to be used as part of a temporary cardiac pacing system. They connect atrial, ventricular, or atrial and ventricular pacing lead systems to a temporary external pacemaker. For more information about the intended use of and the indications for temporary cardiac pacing systems, refer to the technical manuals for the cardiovascular stimulating instruments. The models 5433A, 5433AL, 5433V, and 5433VL reusable patient cables are intended to be used with: • Medtronic endocardial or myocardial pacing lead connector pins 0.38 to 2.41 mm (0.015 to 0.095 in) in diameter and up to 25.4 mm (1.0 in ) long. • Medtronic cardiovascular stimulating instruments.

4 Contraindications The Model 5433A, 5433AL, 5433V, and 5433VL patient cables have no known contraindications.

5 Intended users The cables are intended for use by trained clinicians in a clinical environment.

6 General warnings and precautions Sterilization – The cable is reusable and supplied non-sterile. Sterilize the cable prior to use. Connection order – Connect the cable to the cardiovascular stimulating instrument before connecting it to the pacing leads. When disconnecting the cable, disconnect from the pacing leads before disconnecting from the cardiovascular stimulating instrument. Do not modify – Do not modify this equipment. Modifications may reduce system effectiveness and impact patient health. Inspect the package – Inspect the package and cable before use. Contact a Medtronic representative if the package or cable is damaged. If the package information is damaged – If any information on the outer package is defaced or damaged so that you cannot read it, notify Medtronic. Product compatibility – This accessory has not been tested for use with non-Medtronic products. Storage temperature – Do not expose the cable package to storage temperatures above 30°C (86°F) or below 15°C (59°F). Transit temperature – Do not expose the cable package to transit temperatures above 70°C (158°F) or below -40°C (-40°F). Humidity – Do not expose the cable package to humidity greater than 85%. Technical manual information – If you find information in this manual that is incorrect or illegible, contact your Medtronic representative. Review the system documentation – Because the cable is part of a cardiac pacing system, review all applicable documentation for warnings, complications, precautions, and instructions.

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7 Potential adverse events If a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body. • • • • • • • • • • • • •

Allergic reaction Cardiac arrest Discomfort Dizziness Fever Health care professional or patient experiences discomfort Infection Lethargy Patient cut, or skin pinched or irritated Property or environmental damage Skin disorders Syncope and/or medical intervention Toxic reaction

8 Reprocessing instructions 8.1 Precleaning at point of use After use, wipe the cable with a damp cloth or tissue to remove any visible soil. Do not submerge the cable in a basin with other soiled instruments or devices.

8.2 Cleaning and disinfection Use either of the two cleaning and disinfection methods that are described below: • Manual cleaning and automated disinfection in a washer disinfector • Automated cleaning and disinfection in a washer disinfector Note: The entire cable can be safely cleaned and disinfected in a washer disinfector. Use of an ISO 15883 compliant washer disinfector is recommended. The cable must be cleaned and sterilized before first use and after each subsequent use. Disinfection before sterilization may be required based on the local region/geography and health-care facility rules and procedures. The cable reprocessing processes for this cable were validated. For additional information about cleaning and disinfecting the cable, contact Medtronic Cardiac Rhythm and Heart Failure (CRHF) Technical Services. You can find local Medtronic contact information at www.medtronic.com. 8.2.1 Manual cleaning and automated disinfection in a washer disinfector 1. Refer to Figure 1, page 8 for a description of the different parts of the cable. 2. Avoid getting water or cleaner inside the positive (+) and negative (-) lead ports on the lead connector assembly. 3. Decontaminate the cable by rinsing it in cool tap water or utility water and removing any loose soil with a soft brush. 4. Unscrew the thumb screws until they stop and clean all parts of the thumb screws. 5. After brushing, thoroughly rinse the cable for at least 30 s to remove any remaining loose soil. 6. Presoaking: a. Prepare an alkaline enzymatic cleaning solution using warm tap water or utility water. b. Follow the time and temperature recommendations provided in the alkaline enzymatic cleaner manufacturer’s instructions. c. Submerge the cable, except for the lead connector assembly, in the alkaline enzymatic solution. d. Remove air bubbles from the surface of the cable by agitating or stirring the cable in the solution. 7. Slide the blue or white band, if it is moveable, at least 5 cm along the cable. 8. Ultrasonic cleaning: a. Submerge the cable, except for the lead connector assembly, in an ultrasonic bath containing an alkaline enzymatic cleaner solution. The lid of the ultrasonic cleaner may not close completely. b. Follow the time and temperature recommendations provided in the alkaline enzymatic cleaner manufacturer’s instructions. 9. Lead connector assembly cleaning: a. Avoid getting solution inside the positive (+) and negative (-) lead ports. b. Clean the lead connector assembly using a soft brush and an alkaline enzymatic cleaning solution.

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c. Unscrew the thumb screws until they stop and clean all parts of the thumb screws. d. Wipe all surfaces of the lead connector assembly for at least 5 minutes. 10. Examine the cable for any visible contamination. 11. If visible contamination is found, use a soft brush and the cleaning solution to remove the contamination. Then repeat the Ultrasonic cleaning (Step 8) and Lead connector assembly cleaning (Step 9) steps. 12. First rinse (warm) - Rinse the cable under running warm tap water or utility water for at least 30 s. 13. Second rinse (cold) - Rinse the cable in cold purified water or critical water for at least 10 s. 14. Disinfect in Washer Disinfector: a. Place the cable in the washer disinfector tray. b. Do not put any other devices on top of the cable. c. Run thermal disinfection: Purified water or critical water for 5 min at 93°C (200°F) 15. Gently tap the connector plug and the lead connector assembly on a hard surface to remove any remaining liquid. 16. Wipe the cable dry using a lint-free cloth. Note: The 5433 cable manual cleaning was validated using a 0.5% (v/v) neodisher MediClean forte solution. During preclean, the cable was rinsed in 24°C (75°F) tap water for 30 s. Before ultrasonic cleaning, the cable was immersed in solution for 20 min at 30°C (86°F). Parts of the cable that would not be submerged in the ultrasonic cleaner were wiped for 5 minutes using 2 soft cloths moistened with 2% (v/v) neodisher MediClean forte solution. The submersible parts of the cable were then cleaned in the ultrasonic cleaner for 10 min. After ultrasonic cleaning, the cable was rinsed in 30°C (86°F) tap water for 30 s followed by a 30 s rinse in purified water. 8.2.2 Automated cleaning and disinfection in a washer disinfector 1. Refer to Figure 1, page 8 for a description of the different parts of the cable. 2. Decontaminate the cable by rinsing it in cool tap water or utility water and removing any loose soil with a soft brush. Avoid getting water or cleaner inside the lead ports. 3. Turn the thumb screws all the way out. 4. Thoroughly rinse the decontaminated cable for at least 30 s. 5. Place the cable in the washer disinfector tray. Do not put any other devices on top of the cable. 6. Use an appropriate automated cleaning and thermal disinfection program. The following cycles from the validated method are included as an example: • Rinsing: Cold tap water or utility water for 1 min • Cleaning phase: 0.5% (v/v) neodisher MediClean forte for 5 min at 55°C (131°F) • Neutralization: 0.1% (v/v) neodisher Z for 1 min at 40–45°C (104–113°F) • Rinsing: Warm tap water or utility water for 1 min, approximately 40–45°C (104–113°F) • Thermal disinfection: Purified water or critical water for 5 min at 93°C (200°F) 7. Gently tap the connector plug and the lead connector assembly on a hard surface to remove any remaining liquid. 8. Wipe the cable dry using a lint-free cloth. 9. Dry the cable completely before sterilization. Note: If the cable is not completely dry, sterilization may not be effective.

8.3 Drying The cable must be dry before sterilization. The cable can be dried in an oven at 110°C, ±2°C (230°F, ±3.6°F) for 25 min. Allow the cable to cool to room temperature before packaging for sterilization.

9 Sterilization 9.1 Before the cable is used • Sterilize the cable before use. The cable is reusable and supplied non-sterile. • Choose either steam autoclave sterilization or ethylene oxide sterilization. Use only one method for sterilizing a specific cable. • Once a sterilization method is chosen, use only that method for sterilizing a specific cable. • Cables are reliable up to 25 cycles.

9.2 Before sterilization • Verify that the cable was thoroughly cleaned before sterilizing it. Failure to properly clean the cable could lead to inadequate sterilization. • Verify that the cable is completely dry before sterilizing it. • Do not sterilize the cable in its original package. The original package is not suitable sterilization packaging material. 11

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• Use an acceptable method to determine the effectiveness of the sterilization cycle, such as biological indicators. • The sterilization instructions have been validated by the manufacturer of the medical device as being capable of preparing a medical device for reuse. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials and personnel in the processing facility, achieves the desired result. This requires verification and/or validation and routine monitoring of the process.

9.3 Steam sterilization 1. Place the cable in a suitable autoclavable packaging material (for example, wrap or pouch). 2. Sterilize the cable in a steam autoclave sterilizer programmed to one of the following sets of parameters: Table 1. Steam autoclave sterilization parameters Cycle type Exposure time Temperature Dry time Option 1 Dynamic air 4 min 132°C (270°F) 20 min Option 2 Dynamic air 3 min 134°C (273°F) 20 min Option 3 Dynamic air 3 min 135°C (275°F) 20 min Option 4 Dynamic air 18 min 134°C (273°F) 20 min Option 5 Dynamic air 30 min 121°C (250°F) 25 min Option 6 Dynamic air 7 min 132°C (270°F) 15 min Do not exceed the maximum values of contaminants in condensate from steam, as applicable per ISO 17665 series. Notes: • Medtronic qualified the steam cycles in Table 1 using a Getinge steam sterilizer model 533LS and steam permeable packaging material (STERIKING part number SS5A 7.5 in x 13 in EO/steam permeable pouches). The sterilant used was moist heat. The minimum dry times were qualified using vacuum drying capabilities. Drying cycles using ambient atmospheric pressure may require longer dry times. Due to variability in sterilization systems, contact the manufacturer of your sterilization system for more information regarding procedures. • Any medical device that has been in contact with a patient known to have or suspected to have a prion or prion-related disease, such as Creutzfeldt - Jakob disease, should not be returned to Medtronic and should be quarantined and processed per the guidelines for processing devices contaminated with high-risk tissue at the health care facility.

9.4 Ethylene oxide sterilization 1. Place the cable in packaging permeable to ethylene oxide (for example, wrap or pouch). 2. Sterilize the cable in a 100% ethylene oxide sterilizer programmed to the following parameters: 100% EO cycle Medtronic recommended process parameter Conditioning Conditioning time of 30–35 min at a temperature of 45–55°C (113–131°F) with relative humidity of 55–85% RH and a pressure of 8–14 kPa (1–2 psig) EO exposure Exposure time of 177–183 min at a temperature of 45–55°C (113–131°F) and a pressure of 55–75 kPa (8–11 psig) with a gas concentration of ≥500 mg/L Post-vacuum pressure 20–30 kPa (2.9–4.4 psig) Aeration Minimum aeration time of 12 hours at a temperature of 44–56°C (111–133°F) Note: Medtronic qualified the 100% ethylene oxide (EO) sterilization cycle using a 3M 100% Steri-Vac 5XL EO sterilizer and XL aerator; EO permeable packaging (STERIKING part number SS5A 7.5 in x 13 in EO/steam permeable pouches). The sterilant and concentration used were 100% ethylene oxide. Due to variability in sterilization systems, contact the manufacturer of your sterilization system for more information regarding procedures.

9.5 Visual inspection After the cable is sterilized, visually inspect the cable and connectors: • Repeat the cleaning and sterilization processes if the cable is not clean. • Do not use the cable if it appears damaged. Damage includes, but is not limited to, deterioration of the cable insulation (brittleness, cracking, thinning, bare spots). • Do not use the cable if the conductive wires are exposed. • If the cable fails visual inspection, dispose of the cable in accordance with local environmental requirements.

10 Instructions for use 10.1 Before first use The cable is supplied non-sterile. The cable must be sterilized before being used. Refer to Chapter 9. English

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Caution: Inspect the package and cable before use. Contact a Medtronic representative if the package or cable is damaged.

10.2 Connecting the cable to the temporary pacemaker Caution: Connect the cable to the cardiovascular stimulating instrument before connecting the cable to the pacing leads. When disconnecting the cable, disconnect from the pacing leads before disconnecting from the cardiovascular stimulating instrument. Caution: Improper insertion of the cable plug may damage the connector pins. 1. Orient the cable plug so that the latch is facing upward. 2. Insert the cable plug into the appropriate receptacle on the temporary pacemaker until it clicks (Figure 2). Figure 2. Connecting the cable to the temporary pacemaker

3. Gently pull on the cable plug after inserting it to ensure that the connection is secure.

10.3 Disconnecting the cable from the temporary pacemaker Caution: Do not pull on the insulated cable wire to disconnect the cable. Tension on the wire may damage the cable. 1. Grasp the cable plug. 2. Press down on the latch button of the cable plug. 3. Pull the cable plug straight out of the receptacle on the temporary pacemaker (Figure 3). Figure 3. Disconnecting the cable from the temporary pacemaker

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10.4 Connecting pacing lead systems to the cable Caution: Carefully observe the polarity and the atrial and ventricular designations of the cable connectors with the corresponding pacing leads when making connections. Caution: When connecting pacing leads, finger tighten each terminal knob on the cable lead connector assembly. Do not use any tools. 1. Loosen the connector knobs by twisting each knob counterclockwise until resistance is felt. Observing polarity, insert lead connector pins as shown (see Figure 4). 2. Finger tighten each terminal knob clockwise until snug. Use gentle traction on each lead conductor to verify a secure connection. Figure 4. Connecting the pacing lead to the 5433 patient cable

11 Disposal At the end of its useful life, dispose of the cable in accordance with local environmental requirements.

12 CE mark of conformity

13 Disclaimer of warranty The warnings contained in the product labeling provide more detailed information and are considered an integral part of this disclaimer of warranty. Although the product has been manufactured under carefully controlled conditions, Medtronic has no control over the conditions under which this product is used. Medtronic, therefore, disclaims all warranties, both express and implied, with respect to the product, including, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. Medtronic shall not be liable to any person or entity for any medical expenses or any direct, incidental, or consequential damages caused by any use, defect, failure, or malfunction of the product, whether a claim for such damages is based upon warranty, contract, tort, or otherwise. No person has any authority to bind Medtronic to any representation or warranty with respect to the product. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this disclaimer of warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of this disclaimer of warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this disclaimer of warranty did not contain the particular part or term held to be invalid.

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