Maestro Pneumatic System Instructions for Use Rev AA Jan 2020

EN

5400-200-700 Rev-AA

Contents Introduction... 3 Indications For Use... 3 Contraindications... 3 User/Patient Safety... 3 Accessories... 4 For Use With... 5 Features... 6 Definitions... 7 Symbols... 7 Colors... 7 Instructions... 8 To Prepare the Footpedal... 8 To Connect the Footpedal to the Regulated Gas Supply ... 9 To Apply Regulated Gas... 10 To Prepare the Handpiece for Operation... 10 Care Instructions... 11 To Clean the Footpedal... 11 To Clean the Hose Adapter... 11 To Clean the Attachment and Handpiece... 11 Inspection and Testing... 11 Troubleshooting... 12 Storage and Handling... 14 Disposal/Recycle... 14 Specifications... 14

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5400-200-700 Rev-AA

Introduction This Instructions For Use manual is the most comprehensive source of information for the safe and effective use of your product. This manual may be used by in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians. Keep and consult this reference manual during the life of the product. The following conventions are used in this manual: • A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information. If additional information, especially safety information, or in-service training is required, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. NOTE: The user and/or patient should report any serious product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.

Indications For Use The Stryker CORE Maestro Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Contraindications

EN

User/Patient Safety WARNINGS: • Only trained and experienced healthcare professionals should use this equipment. • Healthcare professionals should be thoroughly familiar with the instructions for use, handling characteristics, and the indicated and intended uses of this equipment. Contact your Stryker sales representative or Stryker customer service for in-service training. • Before using any system component or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the system components prior to use. • The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique used for each patient. Stryker, as a manufacturer, does not recommend surgical procedure or technique. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the Care Instructions section and/or care instructions manual supplied with the handpiece. • Perform recommended inspection and testing as indicated in these instructions. See the Inspection and Testing section and/or the care instructions manual supplied with the handpiece. Only trained and experienced healthcare professionals should maintain this equipment. • Inspect the equipment for damage, as indicated, upon initial receipt and before each use. DO NOT use any equipment if damage or leakage of oil and/or lubrication is apparent. • DO NOT use this equipment in the presence of a mixture consisting of flammable anesthetic and air, or with oxygen or nitrous oxide.

None known.

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5400-200-700 Rev-AA

Accessories WARNINGS: • Use only Stryker-approved components and accessories, unless otherwise specified. • DO NOT modify any component or accessory. • ALWAYS use an appropriate cutting accessory and attachment combination for the handpiece. Other combinations may not fit properly in the handpiece and may bend or come out of the handpiece during operation. See the instructions for use supplied with the attachment for a list of appropriate cutting accessories and installation instructions. • DO NOT reuse, reprocess, or repackage a device that is intended for single use only. - A single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. - Design features may make cleaning difficult. - Reuse may create a contamination risk and compromise structural integrity resulting in operational failure. - Critical product information may be lost during repackaging. Failure to comply may lead to infection or cross infection and result in patient and/or healthcare staff injury. NOTES: • See instructions for use supplied with each attachment for bur installation instructions and specific attachment information. • Contact your Stryker sales representative for a complete list of accessories. Outside the US, contact your nearest Stryker subsidiary.

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The following Stryker-approved accessories are sold separately: DESCRIPTION

REF

Signature Portfolio Attachments

5407-XXX-XXX series

SaberTM Attachments

5100-120-XXX series

Maestro Attachments

5400-210-XXX series

Maestro Oil Cartridge (QTY 10)

5400-005-000

Maestro Diffuser (QTY 10)

5400-006-000

Oil Cartridge/Diffuser Kit

5400-005-006

CORE Auto Irrigator

5400-206-000

CORE Auto Irrigator Sensor Cable

5400-206-001

Maestro Nonexhausting Footpedal

5400-207-000 5400-207-000S1

Maestro Footpedal

5400-208-000

Maestro Universal Footpedal

5400-218-000

Maestro Sterilization Case

5400-279-000

Maestro Sterilization Plugs

5400-200-007

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5400-200-700 Rev-AA

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For Use With NOTES: • See the To Connect the Footpedal to the Regulated Gas Supply section for United States (US) and international connection procedures. • Contact your Stryker sales representative for a complete list of hose adapters. Outside the US, contact your nearest Stryker subsidiary. COUNTRY

HOSE ADAPTER

REF

GAS

United States (US)

DISS to Schrader Air Adapter

5400-200-002

Air

United States (US)

DISS to ARO Air Adapter

5400-200-003

Air

United States (US)

DISS to Instrument Air (US)

5400-200-004

Instrument Air

United Kingdom (UK)

UK Adapter

5400-200-005

Medical Air

Australia (AU)

Australia Adapter

5400-200-006

Surgical Tool Air

Germany (DE)

DIN Adapter

5400-200-008

Medical Air

France (FR)

AFNOR Adapter

5400-200-009

Medical Air

Italy (IT)

UNI Adapter

5400-200-011

Medical Air

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Definitions

A

Cutting Accessory – A variety of cutting accessories are sold separately.

B

Attachment – A variety of attachments are sold separately. See the Accessories section.

C

Handpiece – A high-speed pneumatic motor assembly, hard-connected to a two-tube hose with an exhaust port and a hose connector.

Symbols

D

Handpiece Hose – Connects the handpiece to the exhaust port.

SYMBOL

E

Exhaust Port – Discharges exhaust gas from the handpiece motor assembly.

F

Diffuser – Disperses exhaust from the handpiece motor assembly and collects oil mist.

G

Footpedal – Provides variable speed control and start/stop options.

H

Hose Connector – Allows connection of the handpiece to the footpedal.

I

Oil Cartridge – Provides lubrication for the handpiece motor assembly.

J

Coaxial In-line Oiler with Locking Collar – Retains the oil cartridge and securely locks the hose connector into the footpedal.

K

DISS Nitrogen Hose Adapter (US) – Allows connection of the gas supply hose to the gas supply.

L

Stryker Proprietary Connection – Connects the gas supply hose to the appropriate Stryker-approved hose adapter.

M

Gas Supply Hose – Provides gas to the footpedal.

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The symbols located on the equipment and/ or labeling are defined in this section or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment.

These symbols are located on the fittings of the hose adapters and indicate the type of connector. FITTING TYPE

N2

Nitrogen

AIR

Air, Medical Air, Surgical Tool Air, or Instrument Air

SYK

Stryker Proprietary

Colors A specific color or color combination is present on the hose of each hose adapter and indicates the type of supply gas used with each hose adapter. COLOR

SUPPLY GAS

COUNTRY

Red/White

Instrument Air

US

Black/White

Medical Air

US, UK, DE, FR, IT, AU

Aqua

Surgical Tool Air

AU

Black

Nitrogen

US, UK, DE, FR, IT, AU

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5400-200-700 Rev-AA

Instructions WARNINGS: • DO NOT use oxygen and/or medical oxygen as a gas supply to operate the handpiece. • DO NOT attempt to insert or remove any cutting accessory or attachment while operating the handpiece. • With the attachment lock collar in the RUN position, gently twist and tug the cutting accessory to ensure the cutting accessory is locked in the handpiece before operation. • DO NOT actuate the attachment collar while operating the handpiece. Actuation will suddenly stop and/or overheat the handpiece. • DO NOT kink, pinch, or step on the handpiece hose. DO NOT allow cart wheels to run over the handpiece hose.

To Prepare the Footpedal 1. If the hose connector was wrapped with a surgical huck towel before sterilization, point the end of the connector down and remove the towel from the connector (figure 1). If sterilization plugs were used instead of a towel, point the end of the connector down and remove the plugs. Use a disposable cloth to wipe any excess fluid from the connector.

CAUTION: ALWAYS remove the plug from the oil cartridge and install the oil cartridge into the coaxial in-line oiler to allow gas to pass through the system. If the plug has not been removed, or the oil cartridge has not been installed, the system will not operate. 3. Pull out and remove the plug from the oil cartridge, then install the cartridge into the coaxial in-line oiler. Refer to the arrow on the cartridge for proper installation orientation (figure 3).

Figure 3 – Install the Oil Cartridge 4. Push the hose connector into the coaxial inline oiler (figure 4).

Figure 4 – Install the Hose Connector Figure 1 – Unwrap the Hose Connector 2. Install the diffuser onto the exhaust port of the handpiece hose (figure 2).

5. Pull up on the hose connector to ensure the hose connector is locked into the coaxial in-line oiler. NOTE: To remove the hose connector from the footpedal, push down on the locking collar of the coaxial in-line oiler to unlock the hose connector.

Figure 2 – Install the Diffuser

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5400-200-700 Rev-AA

To Connect the Footpedal to the Regulated Gas Supply WARNING: ALWAYS use Stryker-approved hose adapters. NOTES: • Connecting two or more hose assemblies in series is not recommended due to the loss of pressure and flow. However, two hose adapters may be connected in series only as specified in these instructions. • See the For Use With section to make sure you have the appropriate hose adapter to connect to your regulated gas supply system. • If you are an international customer, see the For International Customers - To Connect to Regulated Gas Supply section. For US Customers - To Connect to the Regulated Gas Supply NOTES: • If using nitrogen, connect the nitrogen end of the DISS Nitrogen Hose Adapter (US) to the regulated gas supply (figure 5). • The illustrated regulated gas supply is representational only. Your regulated gas supply may vary in appearance based on specific facility requirements.

Figure 5 – Connect the DISS Nitrogen Hose Adapter (US) NOTES: • If using air or instrument air, you will need to install the appropriate hose adapter onto the nitrogen end fitting to allow connection to your regulated gas supply. See the For Use With section. • Install the appropriate hose adapter between the DISS Nitrogen Hose Adapter (US) and the regulated gas supply (figure 6). Hand tighten the DISS connection.

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• The illustrated hose adapter is representational only. The supply end fitting of your hose adapter may vary in appearance based on specific facility requirements.

Figure 6 – Install the Appropriate Hose Adapter For International Customers - To Connect to the Regulated Gas Supply 1. Remove the DISS Nitrogen Hose Adapter (US) from the footpedal using a 3/4 inch [19 mm] open-end wrench (figure 7).

Figure 7 – Remove the DISS Nitrogen Hose Adapter (US) NOTES: • You will need to install a country-specific hose adapter with the correct fitting to allow connection to your regulated gas supply. • See the For Use With section or contact your Stryker sales representative for a complete list of hose adapters. Outside the US, contact your nearest Stryker subsidiary.

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Instructions (continued) 2. Install the country-specific hose adapter between the gas supply hose and the regulated gas supply. Use a 3/4 inch [19 mm] open-end wrench to tighten the SYK proprietary connection (figure 8).

Figure 8 – Install the Country-specific Hose Adapter NOTE: The illustrated country-specific hose adapter and regulated gas supply are representational only. Your hose adapter and regulated gas supply may vary in appearance based on specific country requirements.

To Apply Regulated Gas CAUTION: Use compressed nitrogen, air, medical air, surgical tool air, or instrument air from a facility source or from a tank. The gas pressure must be regulated. Particulate matter and moisture will adversely affect the life and performance of the handpiece and footpedal. 1. Turn on the gas supply to pressurize the system. 2. Adjust the pressure regulator to the recommended gas pressure of 830 kPa [120 psi, 8.3 bars]. NOTES: • The recommended gas pressure during handpiece operation is 830 kPa [120 psi, 8.3 bars]. • The static gas pressure is typically 35 to 70 kPa [5 to 10 psi, 0.35 to 0.70 bars] higher than the gas pressure during handpiece operation.

5400-200-700 Rev-AA

To Prepare the Handpiece for Operation WARNINGS: • ALWAYS wear eye protection to prevent eye injuries. • DO NOT rest the handpiece on the patient. Improper handling of the handpiece could result in injury to tissue. • DO NOT apply excessive pressure, such as bending or prying, with the cutting accessory. Excessive pressure may bend or fracture the cutting accessory and cause tissue damage and/or loss of tactile control. • Follow the recommended duty cycle to prevent the components from overheating. See the Specifications section. • Monitor long periods of operation and/or use irrigation to prevent overheating of the cutting accessory. • ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section. 1. Install the attachment and cutting accessory onto the handpiece (figure 9). NOTE: See the instructions for use supplied with the attachment for complete installation information.

Figure 9 – Install the Attachment and Cutting Accessory NOTES: • Elite and Saber burs may be installed in the attachments at several bur exposures. • Compare the incremental marks on the bur shaft to the distal end of the Saber attachment to determine the exposure (figure 10).

Figure 10 – Determine Bur Exposure

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5400-200-700 Rev-AA

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2. Operate the handpiece briefly to make sure the cutting accessory is rotating properly. 3. Adjust the pressure regulator as required to achieve the recommended gas pressure of 830 kPa [120 psi, 8.3 bars] during handpiece operation.

To Clean the Attachment and Handpiece

Care Instructions

NOTE: See the care instructions manual supplied with the handpiece for instructions on inspecting and testing the handpiece.

To Clean the Footpedal 1. Remove and discard the oil cartridge from the coaxial in-line oiler. 2. Wipe the surfaces of the footpedal and the gas supply hose with a disposable cloth moistened with the prepared cleaning solution and rinse with water. 3. Visually inspect the equipment for any remaining soil. If soil remains, repeat the cleaning and rinsing procedure using fresh cleaning solution. 4. Allow the equipment to drain on disposable absorbent wipes. 5. Dry the equipment with a soft, lint-free cloth or medical-grade compressed air, < 138 kPa [< 20 psi, < 1.4 bars]. 6. After cleaning, inspect and test the equipment immediately. See the Inspection and Testing section.

To Clean the Hose Adapter 1. Wipe the surfaces of the hose adapter with a disposable cloth moistened with the prepared cleaning solution and rinse with water. 2. Visually inspect the equipment for any remaining soil. If soil remains, repeat the cleaning and rinsing procedure using fresh cleaning solution. 3. Allow the equipment to drain on disposable absorbent wipes. 4. Dry the equipment with a soft, lint-free cloth or medical-grade compressed air, < 138 kPa [< 20 psi, < 1.4 bars]. 5. After cleaning, inspect and test the equipment immediately. See the Inspection and Testing section.

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See the care instructions manual supplied with the handpiece.

Inspection and Testing

COMPONENT

ACTIVITY (BEFORE EACH USE)

Regulated Gas Supply

Listen for leaks. If leaking is apparent, see the Troubleshooting section.

Footpedal

Inspect the equipment for loose or missing components. Make sure the surface of the gas supply hose and the DISS Nitrogen Hose Adapter (US) is not cut, cracked, or damaged. Check all moving parts for free movement. If damage is apparent, replace the footpedal. See the Accessories section.

Hose Adapter

Inspect the equipment for loose or missing components. Make sure the surface of the hose adapter is not cut, cracked, or damaged. If damage is apparent, replace the hose adapter. See the For Use With section.

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5400-200-700 Rev-AA

Troubleshooting CAUTION: DO NOT service this equipment. If you require service, contact your Stryker sales representative. Outside the US, contact your nearest Stryker subsidiary. PROBLEM

CAUSE

ACTION

Cutting accessory does not turn or the handpiece exhibits reduced power.

Hoses are not connected properly.

Ensure connections between the gas supply, footpedal and handpiece are secure. Ensure the hose connector is locked into the footpedal.

Lubrication is inadequate.

Ensure the plug has been removed from the new oil cartridge. Install a new oil cartridge before every procedure.

Attachment is in the LOAD position.

Rotate the attachment collar to the RUN position.

Gas supply is inadequate.

Ensure the gas supply is set at the recommended operating pressure of 830 kPa [120 psi, 8.3 bars].

Lubrication is inadequate.

Ensure a new oil cartridge is installed before every procedure.

Handpiece hose is cut or damaged or the gas is escaping.

Protect the handpiece hose from damage. If damaged, return the handpiece for repair.

Attachment is loose.

Ensure the attachment is secure.

Motor bearings are worn.

Return the handpiece for repair.

Attachment bearing is worn.

Return the attachment for evaluation.

Lubrication is inadequate.

Ensure a new oil cartridge is installed before every procedure.

Handpiece bearings are worn.

Return the handpiece for repair.

Cool down period after sterilization was inadequate.

Allow the handpiece to cool adequately after sterilization.

Attachment is difficult to remove or install onto the handpiece.

Connectors require a breaking-in period.

Install and remove the attachment from the handpiece repeatedly until the connectors function smoothly.

Attachment will not seat onto the handpiece properly.

Debris is present inside the attachment or handpiece connector.

Clean and sterilize the attachment and handpiece. See the care instructions manual supplied with the handpiece.

Pin and notch are not aligned.

Align the pin with the notch and push the attachment into the handpiece firmly.

Cutting accessory rotates and a grinding or unusual noise occurs.

Handpiece motor assembly is hot to the touch.

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PROBLEM

CAUSE

ACTION

Cutting accessory will not lock in the attachment.

Cutting accessory is not engaged properly.

Insert the cutting accessory into the attachment to at least exposure line mark 5 (Saber/Elite only). Insert the cutting accessory at slightly different rotations until you feel the cutting accessory engage with the attachment.

Handpiece will not function.

Attachment collar is not in the RUN position.

Rotate the collar to the RUN position.

Attachment becomes hot.

Debris is present in the attachment.

Clean and sterilize the attachment. See the care instructions manual supplied with the handpiece.

Attachment bearings are worn.

Return the attachment for evaluation.

The regulated gas supply is not turned on or the pressure regulator is not adjusted properly.

Turn on the regulated gas supply or properly adjust the pressure regulator. See the To Apply Regulated Gas section.

The handpiece hose is not connected properly.

Secure the connections between the handpiece and handpiece hose.

The connection between the gas supply hose and the hose adapter is loose.

Make sure the connection between the gas supply hose and the hose adapter is secure.

The connection between the hose adapter and the regulated gas supply is loose.

Make sure the connection between the hose adapter and regulated gas supply is secure.

Oil cartridge has not been installed in the coaxial in-line oiler.

Install a new oil cartridge into the coaxial in-line oiler.

Oil cartridge plug was not removed.

Remove the plug from the oil cartridge.

Oil appears on the surface of the equipment after sterilization.

Vacuum pressure forced oil out of the handpiece hose during sterilization.

Wrap the hose connector with a surgical huck towel or use sterilization plugs before sterilization. See the care instructions manual supplied with the handpiece.

Excessive hiss is present.

Gas is leaking from the hose adapter.

Make sure all the hose fitting connections are tight. If the hiss persists, replace the hose adapter. See the For Use With section.

The hose adapter will not connect to the gas supply connector.

The hose adapter is not compatible with the gas supply connector.

See the For Use With section to make sure you have the appropriate hose adapter to connect to your regulated gas supply system. See the To Connect the Footpedal to the Regulated Gas Supply section to connect to your regulated gas supply system.

Footpedal is depressed and no gas is delivered to the handpiece.

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5400-200-700 Rev-AA

Storage and Handling See the care instructions manual supplied with the equipment.

Disposal/Recycle See the care instructions manual supplied with the equipment.

Specifications NOTE: Specifications listed are approximate and may vary from unit to unit, or as a result of pressure fluctuations. Model:

CORE Maestro Drill REF 5400-200-000

Dimensions:

7.6 cm [3.0 inch] length 1.7 cm [0.7 inch] diameter

Mass:

130 g [0.29 lb]

Speed:

75,000 rpm at 830 kPa [120 psi, 8.3 bars]

Motor Type:

High-speed, high-torque pneumatic vane

Mode of Operation:

Non-continuous

Duty Cycle:* Cycle Time: Cycle Frequency: Rest Between Cycles:

20 seconds on/20 seconds off 10 times 40 minutes

Power Source:

Compressed nitrogen, air, instrument air, surgical tool air, or medical air

Pressure:

830 kPa [120 psi. 8.3 bars]

Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation:

Humidity Limitation:

Atmospheric Pressure Limitation:

*Recommended duty cycle when the handpiece is used in an environment with an ambient temperature of 27 °C [80 °F] or less.

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ES/DE/FR/IT/NL 5400-200-713 JA/ZH/KO 5400-200-729 SV/DA/FI/PT/NO 5400-200-730 PL/EL 5400-200-750

Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210 2021-01

Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210 5400-200-700 Rev-AA

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