DePuy Synthes
DePuy Batteries
Colibri II Li-ion battery, STERRAD and V-PRO Systems Sterilization Guide
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For Colibri II Li-ion battery (532.103)
STERRAD and V-PRO Systems Sterilization Guide ®
®
1. Preparation Prior to Reprocessing
2. Cleaning and Disinfection
• Before cleaning, remove all instruments and attachments from the power tool. Remove the battery casing from the handpiece and then remove the battery from the battery casing. • Inspect battery for cracks or damage.
A. To clean the battery, wipe it off with a clean, soft, and lint-free cloth dampened with deionized water and dry prior to processing.
Note: Take care not to spray the contacts or touch both contacts at the same time with the damp cloth due to danger of short circuiting. Do not immerse batteries into water or clean them in a washer/disinfector.
B. To disinfect the battery, wipe it off with a clean, soft and lint-free cloth dampened with a minimum of 70% alcoholbased disinfectant for thirty (30) seconds. A disinfectant that is VAH listed, EPA registered or locally recognized is recommended. This step has to be repeated two (2) additional times using a new, clean, soft and lint-free cloth dampened with a minimum 70% alcohol-based disinfectant each time. Follow the instructions provided by the manufacturer of the disinfectant.
3. Charging1
4. Wrapping and Labeling
• Place the battery into the Universal Battery Charger II2 (05.001.204). • Charge the battery. When the green LED illuminates, the battery is fully charged. • Upon completion of charging the battery, wipe the battery with a minimum 70% alcohol-based disinfectant prior to wrapping and labeling.
The batteries can either be wrapped or peel pouched. Follow the instructions for wrapping and labeling with the STERRAD Systems provided by Advanced Sterilization Products or with the V-PRO Systems provided by STERIS.
5. Sterilization
6. Storage and Use3
• Process the battery in the STERRAD or V-PRO Systems following the instructions provided by the legal manufacturer Advanced Sterilization Products or STERIS. • The Colibri II Li-Ion battery (532.103) has been validated with the following:
• Battery can be used immediately or stored in accordance with hospital’s procedures. • Rotate stock and recharge unused batteries, as necessary. • Compared to nickel based batteries the self-discharge rate of the Colibri II Li-Ion battery is less than half during storage 4.
STERRAD and V-PRO Systems and Cycles STERRAD® 50 STERRAD® 200 Short cycle STERRAD® 100S Short cycle STERRAD® NX® Standard cycle STERRAD® 100NX® Standard cycle V-PRO® 1 Lumen Cycle V-PRO® 1 Plus Lumen Cycle, Non Lumen Cycle V-PRO® maX Lumen Cycle, Non Lumen Cycle, Flexible Cycle V-PRO® 60 Lumen Cycle, Non Lumen Cycle Note: No other sterilization methods are allowed.
Warning: • Never expose batteries to temperature over 60°C/140°F. The maximum exposure time at 60°C/140°F is 72 hours. • Do not dismantle, open, or shred batteries. • Do not leave the battery empty of charge as this will reduce its lifetime or damage the battery. • Only sterilize batteries (532.103) with a lot number of 140318 or higher in STERRAD or V-PRO Systems.
1
Universal Battery Charger II with firmware version 11.0 or higher is required to charge Colibri II Li-ion batteries. 2 For detailed information on the Universal Battery Charger II, please refer to the Instructions for Use for the Universal Battery Charger II (DSEM/PWT/1114/0050). 3 For detailed information regarding Storage and Use, please refer to the Instructions for Use for Colibri II (DSEM/PWT/0914/0026). 4 Data on file at DePuy Synthes.
7. S TERRAD or V-PRO Sterilized Battery Insertion
Figure 4
Figure 5
Figure 6
Figure 7
Figure 8
07/18
Figure 3
DSEM/PWT/0915/0081(1)
Notes: • Ensure that the STERRAD or V-PRO sterilized battery does not come into contact with any liquids or other substances whilst being inserted. • For detailed information please refer to the Instructions for Use for the Colibri II (DSEM/PWT/0914/0026). • Following the introduction of the STERRAD or V-PRO sterilization methods, the markings on Colibri II Li-Ion batteries (532.103) have been changed, including replacing “DO NOT STERILIZE” with “DO NOT AUTOCLAVE MAX. 60°C / 140°F”. However, all Colibri II Li-Ion batteries (532.103) with a lot number of 140318 (indicated on the top of the battery) or higher can be STERRAD or V-PRO sterilized regardless of their markings.
Figure 2
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After usage, remove the battery casing from the handpiece and open the lid. The circulating person then removes the battery. Ensure that the battery does not touch the exterior of the battery casing to avoid contaminating the battery. Put the battery immediately in the charger.
Figure 1
STERRAD ® is a registered trademark of Advanced Sterilization Products (ASP), a Division of Ethicon, Inc., a Johnson & Johnson company. V-PRO ® is a registered trademark of STERIS Corporation. This publication is not intended for distribution in the USA. Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland Tel: +41 61 965 61 11 Fax: +41 61 965 66 00 www.depuysynthes.com
For full user instructions and precautions please consult the product IFU. Please contact your DePuy Synthes sales representative for more information. All surgical techniques are available as PDF files at www.depuysynthes.com/ifu
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© DePuy Synthes Power Tools, a division of Synthes GmbH. 2018.
• The scrubbed person performs all of the steps according to Figure 1– 8. • If the sterile battery casing is not opened, press the central button to unlock (Fig. 1), turn lid sideways (90°) as indicated by the arrow (Fig. 2) and pull to open (Fig. 3). Leave the locking mechanism swung outward. • Insert the sterile battery into the battery casing (Fig. 4) and press it completely into the battery casing to ensure a correct seat (Fig. 5). • Close the battery casing (Fig. 6), turn the lid sideways (90°) until it clicks (Fig. 7). • Insert the battery pack into the Colibri II handpiece (Fig. 8).