Description

1.0 INTRODUCTION

It is recommended that personnel study this manual before attempting to operate, clean or sterilize the Linvatec 10k Irrigation System. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, cautionary notices, and instructions marked on the product, and included in this manual. The Linvatec 10k Irrigation Pump uses an assortment of single-use tubing sets to deliver sterile fluid to the operative site during either arthroscopic or laparoscopic surgical procedures.

There are four individual tubing sets: catalog number 10k100, which is a basic tubing set with no suction, used for arthroscopic procedures; catalog number 10k125, which is also a basic tubing set with no suction, used for arthroscopic procedures, but incorporates safety spikes and is used only in Germany; catalog number 10k150, which is a tubing set equipped with a suction line, also used for arthroscopic procedures; and catalog number 10k200, which is a tubing set used for laparoscopic procedures. 

1.1 Intended Use

The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.

1.2 Contraindications

The Linvatec 10k Irrigation System is not intended for hysteroscopic procedures.

1.3 General Warnings

1. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Read and follow all warning and cautionary notices and instructions marked on the product and included in this manual. 

2. Do not open the pump, as this may void your warranty. There are no user-serviceable parts inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerously high voltages or other risks. 

3. Eye protection is recommended when operating equipment. 

4. Use only associated Linvatec tubing sets. 

5. Handle the pump carefully. If the pump is dropped or damaged in any way, return it immediately for service. 

6. Prior to each use, inspect all equipment for proper operation. 

7. Do not excessively bend or kink the power cord. Always inspect for signs of excessive wear or damage. If wear or damage are found, discontinue use and replace immediately. 

8. Disposable irrigation tubing sets are one-time use only. Do not clean, disinfect, resterilize or reuse. After use, dispose of properly. 

9. All associated tubing sets are latex free.

10. Use tubing set only for indicated use. Not intended for hysteroscopic procedures. 

11. Do not allow the tubing line(s) to become crimped. 

12. Do not use the pump in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. 

13. Closely monitor the patient during and after the operative procedure for signs of complications resulting from excess fluid absorption. 

14. Accurate cannula placement is essential to avoid extravasation of fluids. Placement of the cannula should be verified to ensure the distal end is within the joint capsule. 

15. Excessive intra-articular pressure or improper inflow cannula placement may result in extravasation. 16. Visually inspect, examine and palpate the patient’s joint periodically to check for proper distention. 

17. An established outflow is recommended during arthroscopic surgery. 

18. The volume of distention fluid instilled and drained should be monitored throughout the procedure. 

19. Periodically examine the location of the inflow cannula to ensure that the cannula is within the joint capsule. Extravasation may occur as a result of improper cannula placement or excessive intra-articular joint pressure.

20. Monitor fluid intake carefully in cases of known joint trauma with possible capsular defects to avoid excessive effusion. 

21. Do not allow this device to run unattended. Patient safety requires that the pump be continuously monitored during operation. 

22. After each use, thoroughly clean the unit (See “3.1 Cleaning and Sterilization” on page E-14). 

23. Equipment grounding is vital to ensure safe operation. Plug the power cord into a properly earthed mains supply outlet whose voltage and frequency characteristics are compatible with those listed on the unit or in this manual. Do not use plug adapters or extension cords; such devices defeat the safety ground and could cause injury. 

3.0 MAINTENANCE

Regular and proper maintenance of your Linvatec 10k Irrigation Pump are the best ways to protect your investment. It is essential that you have your equipment serviced, as scheduled, in order to retain its optimum performance and reliability, which will reward you with safer, less problematic product performance over time. 

Recommended care and handling of the pump includes proper day-to-day operation and cleaning, which are extremely important to ensure safe and efficient operation. 

Your authorized Linvatec service department is the most knowledgeable about the pump and will provide competent and efficient service. Service at Linvatec, at least once every 12 months, is mandatory to keep your product warranties in effect. Any services and/or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure.

3.1 Cleaning and Sterilization

3.1.1 Pump Cleaning

CAUTION: Never immerse the pump in any solution. 

WARNING: The disposable irrigation tubing sets are one-time use only. Do not clean, disinfect, resterilize or reuse. Dispose of properly.

1. Follow universal precautions for protective apparel when handling and cleaning contaminated instruments. 

2. Disconnect the pump from the electrical power source. 

3. Wipe the pump with a clean, soft cloth dampened with a mild, pH-balanced detergent. 

4. Thoroughly clean the tubing roller area. Ensure rollers are free of all debris. 

5. Wipe equipment again with distilled or sterilized water. 

6. Dry all areas thoroughly

3.2 Troubleshooting

3.5 Technical Specifications

3.5.1 Pump Operating Specifications

I.E.C. Equipment Classification: Patient Applied, continuous operation with intermittent loading

as Class 1, Type BF per IEC 601-1, UL2601-1 and CUL601.1.

Medical electrical equipment with respect to electric shock, fire, electromagnetic compatibility,

mechanical and other specified hazards only in accordance with UL 60601-1, CAN/CSA C22.2

No. 601.1, IEC 606-1-1-2 and IEC 60601-1, 2nd Edition including amendments 1 and 2, 18FF.

Typical Operating Requirements:

Input Voltage: 90 – 240 VAC

Frequency: 50/60 Hz

Maximum Current: 1 A

Line Frequency Leakage: Less than 100µa

Fuses: 1.0 A, Slow Blow, 5 x 20 mm

Fluid Pressure Ranges:

Arthroscopy: 30 – 150 mmHg (Factory default at 40 mmHg)

Laparoscopy: 10 – 100% (0 – 1800 ml/min. Factory default at 100%)

Dimensions: 7.75” (W) x 6.5” (H) x 8.0” (D)

19.7 cm (W) x 16.5 cm (H) x 20.3 cm (D)

Weight: 7.0 lbs. (3.15 kg)

NOTE: There are no toxic components used in the manufacture of the Linvatec 10k irrigation

System. After the useful life of the product, dispose of components and service parts properly.