Instructions for Use
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Battery Operated Screwdriver BOS Driver Instructions for Use / Technical Description
REV#: 07 KLM No. 90-036-52-10 50-800-01-07 Date of Release: 2020-03-18
Instructions for Use / Technical Description BOS Driver
Contents 1
General Information ... 4
2
Notices Concerning this Document... 5
2.1
Symbols Used in this Document ... 5
3
Product Liability and Warranty ... 5
3.1
Hotline ... 6
4
Scope of Delivery ... 7
4.1
User’s Inspection ... 7
5
Intended Use ... 8
5.1 5.2 5.3
Intended Purpose ... 8 Users... 8 Limitations of Use ... 8
6
Application ... 9
6.1 6.2
Components / Assembly ... 9 Preparation of the BOS Driver for Use ... 9
6.2.1
Connecting the battery pack to the handle ... 9
6.2.2
Insertion of a blade ...10
6.3 6.4
Using the BOS Driver ... 10 After Use... 11
6.4.1
Blade removal ...11
6.4.2
Battery pack removal ...12
7
Processing, Cleaning, Disinfection and Sterilization ... 13
7.1
Cleaning / Disinfecting... 13
7.1.1
BOS Driver (manual) ...13
7.1.2
Screw driver blades (machine processing) ...14
7.1.3
Battery pack ...14
7.2 7.3
Visual Check for Damage ... 14 Sterilization ... 15
8
Maintainance / Repair ... 16
8.1 8.2 8.3
Safety Checks (SC) ... 17 Troubleshooting ... 18 Accessories & Spare Parts ... 19
9
Disposal of the Device and Battery ... 20
10
Technical Data ... 21
10.1 10.2
BOS Driver ... 21 Battery pack ... 22
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Instructions for Use / Technical Description BOS Driver
10.3
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Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC) ... 23
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Instructions for Use / Technical Description BOS Driver The Symbol Glossary is located on the last page of this IFU.
1
General Information
The Battery Operated Screwdriver is manufactured and distributed by the KLS Martin Group. Manufacturer: Karl Leibinger Medizintechnik GmbH & Co. KG Kolbinger Str. 10, Mühlheim an der Donau, Germany 78570 Tel: +49 7463 8380 Distributor: KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, Florida 32246 Tel: 1-904-641-7746 www.klsmartinnorthamerica.com
KLS Martin only guarantees the proper functioning of the device if the following rules are observed: •
National requirements for installation and operation
•
National requirements for fire and explosion prevention
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Instructions for Use / Technical Description BOS Driver
2
Notices Concerning this Document
Non-observance of this document can lead to serious or even lethal patient or user injury! Improper handling and care as well as non-intended use can lead to premature wear and/or pose a risk to patients and users! It is the operator’s responsibility to ensure that all personnel handling the product have understanding and observe the notes and instructions in this document. •
Every user is required to read this document completely and follow it carefully.
•
In particular, be sure to heed all cautions, warnings, and danger notices.
•
Keep this document accessible to users at all times.
2.1
Symbols Used in this Document
Throughout this document, important information (such as general or safety-related notices) is marked with the following symbols and signal words:
WARNING Life hazard or danger of serious injury! Indicates a situation which, if not avoided, could result in death or serious injury!
CAUTION Risk of injury! Indicates a situation which, if not avoided, could result in minor or moderate injury!
NOTICE Risk of material damage! Indicates a situation which, if not avoided, could lead to material damage (loss of time, data loss, device/machine failure, etc.)!
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Product Liability and Warranty
Our Standard Terms and Conditions of Sale effective at the time of purchase shall apply. Agreements diverging from these Standard Terms and Conditions do not restrict the legal rights of the buyer. REV#: 07
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Instructions for Use / Technical Description BOS Driver Any warranty exceeding the above provisions shall require a contractual form and shall exclude component-related vandalism, software updates and consumables. In order to avoid damage due to improper installation or use and not to compromise the warranty or guarantee, this KLS Martin system must not be used in conjunction with thirdparty systems.
3.1
Hotline
Should you have any questions on how to handle the product or use it for clinical applications, please do not hesitate to contact our Product Management Department at: Tel: 800.625.1557
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4
Scope of Delivery
Designation
REF
BOS Driver handle
50-800-01-07
This Instructions for Use (BOS Driver)
KLM No. 90-036-52-10
4.1
User’s Inspection
•
Immediately upon receipt, the goods must be checked for completeness and potential damage in transit.
•
Notice of any such damage must be reported immediately.
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5
Intended Use
5.1
Intended Purpose
The battery-operated screwdriver “BOS Driver” is a cordless instrument for the application of bone screws.
5.2
Users
The BOS Driver may only be used by competent medical staff that due to their specialized training, experience, and knowledge of the relevant regulations, has the necessary qualification for using the system correctly. Users must have adequate knowledge of the rules of medical practice. The user must be thoroughly familiar with the surgical technique as well as with the implants and the instruments and accessories used. The user bears the responsibility for: •
the proper performance of the surgical procedure
•
selecting the right implant components and implanting them properly
•
avoiding or minimizing the general risks posed by surgical interventions
5.3
Limitations of Use
The BOS Driver may only be used by competent medical staff for the application described, paying due regard to: •
current safety-at-work regulations
•
current accident prevention regulations
•
these Instructions for Use
According to the above provisions, it is the user’s responsibility to: •
ensure that all working equipment used is in perfect condition
•
protect himself/herself, patients, and third-parties from hazards
KLS Martin shall not be responsible for complications caused by wrong indications, wrong implant selection, incorrect combination of system components and surgical technique, limitations of the treatment used, or lack of hygiene. The operational safety of the device must be verified at regular intervals, see section 8.1 “Safety Checks” (SC). If the device is not functionally reliable and/or safe to operate, it must be marked as such and withdrawn from service. A technical check is mandatory in any such case. In order to avoid damage due to improper installation or use and not to compromise the warranty or guarantee, this KLS Martin system must not be used in conjunction with thirdparty systems.
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6
Application
6.1
Components / Assembly
Blade/Tool
Handle without battery pack (50-800-01-07)
Battery pack, sterile (50-800-02-71)
6.2
Preparation of the BOS Driver for Use
Prior to using, the BOS (without battery pack) has to undergo a reprocessing with an appropriate cleaning, disinfection, and sterilization method. Detailed information for this purpose is available in section 7 “Processing, Cleaning, Disinfection and Sterilization“. 6.2.1
Connecting the battery pack to the handle
WARNING Danger of injury from electric shock and explosion! To prevent any risk of electric shock, this device may only be connected to the intended battery pack. A connection with any other power supply is forbidden. Do not create a short circuit across the battery pack terminals. This can cause excessive heat to build up, leading to an explosive condition.
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Instructions for Use / Technical Description BOS Driver The battery pack (which is not included in the scope of delivery) is sterile packed and can directly be connected from the packaging to the previously sterilized BOS under sterile circumstances.
Insert the battery pack with the broad hook into the lower indent of the handle. Swing the battery pack upward to snap it into the upper indent of the handle. 6.2.2
Insertion of a blade
Press the sleeve backward and hold. Insert the blade while twisting until there is a clear lock. Release the sleeve to firmly position the blade. Prior to use please check the firm fit of the blade and the function of the device using the function keys.
6.3
Using the BOS Driver
WARNING Explosion hazard! The BOS Driver is not suitable for use in atmospheres enriched with flammable mixtures of anesthetics and air, oxygen, or nitrous oxide.
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CAUTION Danger of hot surface! The batteries in the battery pack may become hot as a result of fast discharge.
For power-driven screw insertion, press the button for the desired speed (fast forward ① or slow forward ② ). To remove screws, press the “reverse” button ③ .
The battery-operated screw driver can also be used for the manual insertion or explantation of screws. For this purpose, please activate the drive lockout. Press one of the buttons ① ② ③ and slide the ratchet backwards, this means towards the instrument body. As soon as the drive lockout mechanism is locked in place, on the left hand side of the ratchet a sign “lock closed” will appear.
To deactivate the drive lockout, please pull back the ratchet, this means away from the instrument body. The pressing of a button is not necessary. As soon as the drive lockout mechanism is deactivated, on the right hand side of the ratchet a sign “lock open” will appear.
6.4
After Use
6.4.1
Blade removal ①
②
Press the sleeve backward (①) and remove the blade from the handle (②). REV#: 07
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Instructions for Use / Technical Description BOS Driver 6.4.2
Battery pack removal
WARNING Fire risk! Only use battery packs specified by manufacturer! The device must not be combined with other devices.
Grasp the handle of the BOS Driver in one hand and the battery pack in the other hand. Press from the upper side against the battery pack to disconnect the upper hook of the battery pack first. Please swing the battery pack down and disconnect the lower hook. The battery pack has to be disposed separately from household waste. Further information is available in section 9 “Disposal of the Battery”.
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7
Processing, Cleaning, Disinfection and Sterilization
NOTICE The responsibility for proper cleaning, disinfection, and sterilization of the handpiece rests with the operator/user. Be sure to observe your national/local regulations, including potential restrictions. Use appropriate and approved sterile packaging (e.g. in accordance with ANSI/AAMI ST79 and ISO 11607) for sterilization, subsequent transportation, and storage. For sterilization, KLS Martin recommends the use of an FDA-cleared wrap. The BOS storage (REF 55-969-19-04) is only suitable for the storage of the handle and the tools during sterilization. It is not designed for the purposes of a wash tray.
7.1
Cleaning / Disinfecting
7.1.1
BOS Driver (manual)
We recommend a manual pre-cleaning with non-fixating cleaning and disinfecting detergents available at the operating facility. •
Carefully wipe the external surface of the unit with a non-corrosive disinfectant according to the manufacturer’s instructions.
•
Rinse the handle of the BOS Driver thoroughly. For the final rinsing, the use of fully demineralized water is recommended.
For cleaning, use only neutral or mild-alkaline cleaners certified for cleaning anodized surfaces.
CAUTION Do not immerse the handle in liquids. Do not use any sharp, pointed, scratching or cutting tools – such as metal brushes or similar devices – for cleaning the silicone buttons. Non-observance of this notice can damage the black control buttons, thus leading to failure of the unit.
NOTICE Machine cleaning and disinfection is not possible.
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Instructions for Use / Technical Description BOS Driver Following cleaning, always spray the head of the screwdriver with a medically approved instrument care spray. 7.1.2
Screw driver blades (machine processing)
We recommend a manual pre-cleaning with non-fixating cleaning and disinfecting detergents available in the operating facility. The blades are suitable for machine processing/thermal disinfection. They can be processed with the same programs that have been released for surgical instruments and implants. In regards to cleaning, be sure to follow the instructions provided by the manufacturer of your washer/disinfector(s) (W/D) as well as those provided by the manufacturers of the cleaners and disinfectants used. The process (including loading) must guarantee sufficient removal of residues. 7.1.3
Battery pack
NOTICE The battery pack has been sterilized due to gamma sterilization before delivery. The battery pack is for single use only. The used materials and batteries would be destroyed due to cleaning and disinfection detergents and/or high temperatures. It must not be cleaned, disinfected, or re-sterilized. Recharging of the batteries is not possible. Even after accidental opening of the packaging the battery pack must be discarded.
7.2
Visual Check for Damage
WARNING Danger of infection and injury by damaged components! Do not use the BOS Driver with a damaged handle and/or damaged blades!
Perform a visual check of the handle and the driver blades prior to sterilization. Verify the integrity of the function keys prior to use.
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7.3
Sterilization
WARNING Danger of infection due to non-sterile handling! Improper sterilization and non-sterile handling of the BOS Driver can lead to serious health hazards for patients. Sterilization must be carried out according to a validated steam sterilization process, for example in a sterilizer complying with ANSI/AAMI ST79, validated in accordance with ISO 17665-1. ANSI/AAMI ST79 recommends a minimum cycle time of 4 min at 132°C (270°F) for dynamic air removal steam sterilization cycles. Please follow the instructions of the user manual of your steam sterilizer. The validated procedures require the use of FDA-cleared sterilizers, sterilization trays, sterilization wraps, biological indicators, chemical indicators, and other sterilization accessories labeled for the sterilization cycle recommended. The health care facility should monitor the sterilizer for the facility according to an FDA recognized sterility assurance standard such as ANSI/AAMI ST79. The BOS Driver (without battery pack) and the blades are suitable for steam sterilization.
NOTICE Danger of patient infection or injury! The warranty in regard to cleaning and sterilization of the BOS is limited to 100 reprocessing and sterilization cycles.
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Instructions for Use / Technical Description BOS Driver
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Maintainance / Repair
WARNING Risk of injury due to unauthorized modification of the product! Altering the product in any way can pose a life hazard due to electric shock! Therefore, unauthorized modifications are strictly forbidden under any circumstances. The maintenance is limited to the visual check and the Safety Checks (SC) according to section 8.1. Important Notices The product may only be repaired by KLS Martin or a qualified person or firm expressly authorized by KLS Martin to perform such work. Improper repairs or alterations performed by third parties during the warranty period shall void any and all warranty claims. Performing unauthorized actions on the product is strictly prohibited at any time. Non-compliance will void any liability claims against KLS Martin.
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8.1
Safety Checks (SC)
NOTICE All safety checks must be documented in the medical device logbook together with the inspection and test results!
Frequency and scope of the safety check are described below. (see IEC 62353) Once a year a safety check must be carried out in order to verify that the BOS Driver fully conforms to safety regulations. The results of each check must be documented and the proper working condition of the unit confirmed by the person performing the check. Frequency:
annually
Device:
Device class (MDD):
IIa
Number of applications
BOS Driver
Inv. number:
Visual check
OK
not OK
OK
not OK
Outer unit surfaces (i.e. housing, buttons, contacts) Accessories complete Instruction for Use available
Functional test Device is working (Installation of the battery pack and functional test) Measures taken Technical Service contacted
Date:
Device withdrawn from service
Date:
Person performing the checks/tests:
REV#: 07
Date:
Signature:
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Instructions for Use / Technical Description BOS Driver
8.2
Troubleshooting
Problem
Cause
Detection
Malfunctioning of the batteryoperated screwdriver
No contact between the battery pack and the screwdriver handle
The contacts are too closely impacted
The batteries in the battery pack are discharged
The tool does not turn (despite running motor)
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Correction
Bend the contacts outward, but not more than 45°
Insert a new battery pack
The battery pack is put on incorrectly
The battery pack does not lock with the handle
Insert the battery pack (see page 13)
The drive lockout (ratchet) is activated
The following sign is visible in the front area of the blade mount:
The drive lockout (ratchet) needs to be deactivated (see 6.3 Using the BOS Driver on page 13)
The tool is inserted incorrectly
The tool can be pulled out easily from the blade mount
Insert the tool correctly (see page 14)
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Instructions for Use / Technical Description BOS Driver
8.3
Accessories & Spare Parts
WARNING Danger of injury in the event of using non-approved accessories! Be sure to use only the genuine parts available from the manufacturer.
Description
REF
BOS Driver
50-800-01-07
Battery Pack (1 PC)
50-800-02-71
Blade Centre-Drive 1.0 mm
50-810-10-07
Blade Centre-Drive 1.5 mm
50-810-15-07
Blade Centre-Drive 2.0 / 2.3 mm
50-810-20-07
Blade Centre-Drive 2.0 long, for use in combination with transbuccal set
25-540-98-07
Blade maxDrive® 1.5 mm
50-817-15-07
Blade maxDrive® 2.0/2.3 mm
50-817-20-07
Blade Cross Drive 1.5 mm
50-815-15-07
Blade Cross Drive 2.0 / 2.3 mm
50-815-20-07
Blade Cross Drive 2.0 / 2.3 mm for use in combination with transbuccal set
25-540-97-07
Blade Cross Drive 2.7 mm
50-815-27-07
Blade Cross Drive 2.7 mm, long, for use in combination with transbuccal set
50-018-97-07
Storage BOS storage tray, complete
55-969-19-04
Storage module (without lid)
55-969-50-04
Lid for BOS system
55-963-19-04
Insert for blades
55-964-41-04
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Instructions for Use / Technical Description BOS Driver
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Disposal of the Device and Battery
Be sure to observe the general national rules on handling packaging and contaminated material. The battery pack needs to be removed from its black plastic cover prior to disposal. Separate the batteries from the battery pack as indicated in the following illustrations: Strike the battery pack towards the surface of the table and remove the batteries. After removing the batteries, dispose of the battery pack in accordance with the appropriate Operating Room procedures. The batteries must be disposed of separately in compliance with the corresponding regulations in force in the user’s country, paying due regard to current environmental regulations.
Marking of electric and electronic equipment in accordance with Directive 2002/96/EC (WEEE Directive) and the German Electrical and Electronic Equipment Act (ElektroG) This symbol on the product or its packaging indicates that the product may not be disposed of as normal household garbage.
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