SafeAir Compact Smoke Evacuator Instructions for Use Rev AA July 2019

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700000406523 Rev-AA

Contents

Introduction

Introduction... 2

This instructions for use manual contains the information intended to ensure the safe, effective, and compliant use of your product. Keep and consult this reference manual during the life of the product.

Audience... 2 Conventions... 2 Contact Information... 2 Indications For Use... 2

Audience

Contraindications... 2

This product is to be used only by qualified healthcare providers who are trained in the particular techniques and surgical procedures to be performed.

System Overview... 3 Safety Directives... 3 General Safety... 3

Conventions

Electrical Safety... 4

The following conventions are used in this manual:

Supplied Components... 4 For Use With... 4 Features... 5 Front Panel Controls... 5 Rear Panel Controls... 5 To Install and Operate the Foot Pedal... 7 Definitions... 7 Symbols... 7 Abbreviations... 8 Instructions... 8 Before First Use... 8 Before the Procedure... 8 During the Procedure... 10 After the Procedure... 10 Cleaning... 10 Inspection and Preventive Maintenance... 11 Storage and Handling... 11 Troubleshooting... 12 Service... 13 Disposal/Recycle... 13 SafeAir ULPA Filter... 13 SafeAir Compact Smoke Evacuator... 13 Power Supply Unit and Power Cord... 13 Specifications... 14

▪▪ 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.

Contact Information For additional information, including safety information, inservice training, or current literature, contact your Stryker sales representative or call Stryker Customer Service at 1-800-253-3210. Outside the U.S., 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 SafeAir Compact Smoke Evacuator is intended to remove and filter smoke generated during electrosurgical and laser procedures.

Contraindications None known.

Product Safety Certification... 15 Product Safety Compliance... 15 Electromagnetic Compatibility... 15

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System Overview The SafeAir Compact Smoke Evacuator is non-sterile and is used for suction and evacuation of surgical smoke from a surgical site. The SafeAir Compact Smoke Evacuator is designed for use in a patient environment. The compact unit is assembled around a vacuum pump and a disposable SafeAir ULPA Filter with activated carbon. The SafeAir Compact Smoke Evacuator can work together with smoke evacuation monopolar electrosurgical pencils or with tubing used only for smoke evacuation. Both monopolar electrosurgical pencils and tubing are applied parts. See the For Use With section for a complete list of required components and optional accessories.

Safety Directives General Safety WARNINGS: ▪▪ Before using this equipment, read and understand the instructions for use. Pay particular attention to safety information. Become familiar with the equipment before use. ▪▪ Equipment is limited to professional use within a professional healthcare environment. ▪▪ 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 customer service for in-service training if you have questions. ▪▪ 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. ▪▪ The SafeAir Compact Smoke Evacuator is not intended for use in laparoscopic procedures as device effectiveness in these procedures has not been established. ▪▪ ALWAYS turn on the smoke evacuation function to avoid the potentially harmful effects of smoke, generated during laser-based procedures, on the patient and the surgical team. ▪▪ DO NOT disassemble, modify, service, or repair any equipment without the authorization of the manufacturer. For assistance, contact Stryker.

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▪▪ The Foot Pedal must be cleaned and checked regularly, especially if it is exposed to fluids and/or chemicals. ▪▪ The synchronization sensor can only be used with IEC 60601-2-2 tested monopolar electrosurgical devices. The Foot Pedal should be used and activated when using Bi-polar electrosurgical devices with the SafeAir Compact Smoke Evacuator. ▪▪ DO NOT connect more than one instrument at a time. Doing so may cause simultaneous activation of the instruments. ▪▪ Do not connect wet instruments to the machine. Prior to use, ensure all instruments are connected correctly to avoid electric shock hazard. ▪▪ In case of malfunction or irregular sounds, the SafeAir Compact Smoke Evacuator must be turned off immediately by pressing the On/Off button and removing the power plug. Contact Stryker for service. See the Contact Information section. ▪▪ ALWAYS avoid blockage of the evacuator exhaust. Blockage can lead to leakage in the system, uncontrolled release of evacuated smoke and damage to the evacuator. ▪▪ DO NOT block the air inlet and cooling air outlet, located on the bottom plate. Blocking the inlet could damage the electronics and the vacuum pump. ▪▪ The use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment, and other equipment should be observed to verify that they are operating normally. ▪▪ The SafeAir Compact Smoke Evacuator is intended for filtration of surgical smoke and not intended to evacuate liquids. Liquids must not enter the evacuator. Always protect the evacuator and its filter against fluids. If liquid enters the filter accidentally, discontinue use and replace the filter immediately. ▪▪ Before using this equipment with any compatible accessory (monopolar tools or smoke tubing), be sure to read and understand the instructions for use. Follow manufacturer’s instructions for disposal or disinfecting and resterilization. ▪▪ The SafeAir Compact Smoke Evacuator must only be connected to the external Power Supply Unit (PSU) provided as part of this product. ▪▪ Position the SafeAir Compact Smoke Evacuator and Power Supply Unit so that the main plug is within easy reach. ▪▪ Transport should only be undertaken in the original packaging.

▪▪ To lift the SafeAir Compact Smoke Evacuator, use the empty filter tray and the upper edge of the rear panel, as handles.

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▪▪ Prior to activation of the SafeAir Compact Smoke Evacuator, the suction should be set on the low setting. When the SafeAir Compact Smoke Evacuator is activated, check to ensure the smoke from the surgical site is completely evacuated by the suction. The time delay function should be set for the level of smoke generated (e.g., large volume = slightly longer delay). In the event the surgical smoke is not being cleared effectively, the suction can gradually be increased until the smoke is completely evacuated from the surgical site. Care should be taken to avoid suction coming in contact with tissue surfaces as powerful suction could damage to the surrounding tissues.

▪▪ The SafeAir Compact Smoke Evacuator may not operate as intended, or it may fail, if used in the vicinity of portable or mobile HF (High Frequency) communication devices that emit electromagnetic waves. See the Electromagnetic Compatibility section for recommended distances between portable and mobile HF communication equipment and the SafeAir Compact Smoke Evacuator.

▪▪ If the SafeAir Compact Smoke Evacuator has been dropped, the SafeAir Compact Smoke Evacuator should not be used until the unit has been checked/ serviced by an local authorized service representative.

DESCRIPTION SafeAir Compact Smoke Evacuator Power Cord External Power Supply Unit Silencer/Filter (mounted on the rear panel) SafeAir ULPA Filter (not inserted in the filter tray)

▪▪ DO NOT wrap the instrument cords around metal objects. ▪▪ Do not place any other instruments on the top of the device as this may cause the machine to overheat. ▪▪ Do not place anything adjacent to the sides to avoid the risk of damage.

Electrical Safety WARNINGS: ELECTRICAL SHOCK HAZARD ▪▪ ALWAYS connect this equipment to a hospital-grade, facility power receptacle with protective earth ground. ▪▪ DO NOT connect wet instruments to the machine. Prior to use, ensure all instruments are connected correctly to avoid electric shock hazard. ▪▪ DO NOT use the SafeAir Compact Smoke Evacuator with plug adapter surge protector strips or extension cords. ▪▪ To isolate equipment from the Supply Mains, disconnect the power cord. ELECTROMAGNETIC INTERFERENCE HAZARD ▪▪ Take special precautions regarding electromagnetic compatibility (EMC) when using this medical electrical equipment. Install and place this medical electrical equipment into service according to the EMC information contained in this manual. ▪▪ The use of accessories and/or cables other than those specified, with the exception of those sold by the manufacturer as replacement parts for internal components, could result in increased emissions or decreased immunity of the equipment or system.

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Supplied Components This table identifies supplied components with the purchase of REF 0703-045-000.

▪▪ Symbol Definition Chart Symbol Definition Chart Instructions for Use (IFU)

QUANTITY 1 1 1 1 1

1 1

NOTE: If any component is missing or damaged, contact Stryker for assistance. See the Contact Information section.

For Use With This section identifies components intended to be used with the equipment to obtain a safe combination. WARNING: Use only Stryker-approved equipment, unless otherwise specified. NOTE: For a complete list of components or ordering information, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. The following Stryker-approved accessories are sold separately: DESCRIPTION Accessories SafeAir ULPA Filter Smoke Tubing, Canister, Fluid Trap Foot Pedal, Compact, Smoke Evacuator

REF 0703-040-000 0703-045-100 0703-045-001

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Features Front Panel Controls B

C

A

D

Filter Life

E

F

Vacuum Suction

Suction Activation

High

Time Delay

G

10 sec

Sensor Continuous

Replace Filter Reset

Press

Low

0 sec

Figure 1 – Front Panel Controls A

Stand-by button (ON/OFF)

E

Vacuum Suction Control

B

Synchronization Sensor

F

Suction activation mode selector

C

Filter tray (filter not inserted in Figure 1)

G

Time Delay Control

D

Filter life indicator (LED)

Rear Panel Controls

Figure 2 – Rear Panel Controls H

Power Cord

L

Grounding pin

I

External Power Supply Unit

M

USB Port Type B

J

Power Supply Cord receptacle

N

Carrying handle

K

Foot Pedal socket

O

Silencer/Filter

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A - Stand-by button (ON/OFF) Pressing the On/Off button enables power to the SafeAir Compact Smoke Evacuator. A green LED light indicates confirmation. Pressing the On/Off button again places the SafeAir Compact Smoke Evacuator in standby mode.

Indicator Lights Light

Green

NOTE: User customized settings are memorized.

B - Synchronization Sensor The SafeAir Compact Smoke Evacuator can be synchronized with an electrosurgical unit (generator) through the synchronization sensor and a IEC 60601-2-2 tested monopolar electrosurgical pencil with smoke evacuation tubing. Synchronization is possible with most electrosurgical units that has been tested to and complies with the IEC 60601 and EN 60601 standards (e.g., Valleylab Force Triad).

Definition Ready for use and visually displays the level of selection. Indicates that the SafeAir ULPA Filter is at or near the end of its useful life. Replacement is required to enable the normal function of the equipment.

Red

E - Vacuum Suction Control The Compact Smoke Evacuator provides individually adjustable suction power in 10 levels ranging from Low to High. The suction power can be adjusted by pressing the or button.

Vacuum Suction High

The below table and chart shows the suction flow rate values.

Low

Vacuum Suction: 0 = Low, 10 = High. Flow Rate: ▪▪ 0 L/min = Low.

C - Filter Tray

▪▪ 90 L/min = High.

The SafeAir ULPA Filter contains active carbon which removes odors and smoke contaminants from the evacuate air. When empty, the filter tray serves as a handle for lifting the device in combination with the upper edge of the rear panel. If no SafeAir ULPA Filter is inserted in the filter tray, the filter life indicators flash on and off and the SafeAir Compact Smoke Evacuator cannot be activated.

SUCTION FLOW RATE VALUES VACUUM SUCTION FLOW [L/MIN] 0 0 1 40 2 45 3 50 4 55 5 60 6 65 7 75 8 80 9 85 10 90

D - Filter Life Indicator

SafeAir™ Compact Smoke Evacuator Suction flow value for different levels

Suction flow (L/min)

The SafeAir ULPA Filter lifetime is 5 hours of usage. See the Specifications section. The filter operating time is indicated by green LEDs. One LED indicates one hour of usage. A red LED illuminates, when the filter has been used for 5 hours and needs to be replaced. See the Indicator Lights section.

100

...

90

...

80

...

70

...

60

...

50

...

40

...

30

...

20

...

10

...

0 1

2

3

4

5

6

7

8

9

10

Suction power level (adjustable menu)

Figure 3 – Suction Flow Chart

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NOTE: The values stated in Figure 3 are specific to the suction flow rate when the unit is connected to a SafeAir Smoke Pencil.

L

F - Suction Activation Mode Selector

M

Suction Activation

Continuous

The SafeAir Compact Smoke Evacuator can initiate smoke evacuation with three different variations and activates suction by pressing one of the following buttons.

Connect grounding cable to provide an alternative path for current back to the ground.

▪▪ Foot Pedal activation when using the Foot Pedal accessory. NOTE: The Foot Pedal is sold separately. See the For Use With section.

USB Port Type B The USB port Type B is for Stryker service access only.

N

Carrying handle The upper edge of the rear panel is used for lifting the device in combination with the empty filter tray on the front.

▪▪ Electrosurgical pencil activation when the evacuator is synchronized with the electrosurgical unit. ▪▪ Continuous activation for uninterrupted suction.

Grounding pin

O

Silencer/Filter The SafeAir Compact Smoke Evacuator is supplied with a silencer to reduce noise and filter to purify exhaust air.

To Install and Operate the Foot Pedal

G - Time Delay Control Time Delay 10 sec

0 sec

The Time Delay function only operates when the SafeAir Compact Smoke Evacuator is synchronized with the electrosurgical unit. The Time Delay function delays the stop of aspiration by up to 10 seconds when the electrosurgical pencil activation is stopped. To operate the Time Delay controls, hold or repeat, by pressing the buttons and .

H

Power Cord

I

The Power Cord has a output IEC320-C14 connector and is inserted in the Power Supply Unit to deliver 100-240 VAC electrical power. The plug with protruding pins is placed into a hospital-grade, facility power receptacle. External Power Supply Unit The Power Supply Unit (PSU) provides DC electrical power to the SafeAir Compact Smoke Evacuator. The PSU has a inlet connection socket to connect with the Power Cord.

J

Power Cord receptacle

K

The SafeAir Compact Smoke Evacuator external Power Supply Unit is connected to the Power Cord receptacle. Foot Pedal socket The Foot Pedal, if used, is connected to the plug-in connection on the rear of the SafeAir Compact Smoke Evacuator

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Figure 4 – Foot Pedal 1. Connect the Foot Pedal in Figure 4 to the SafeAir Compact Smoke Evacuator at the Rear Panel. See the Features section. 2. Press the Foot Pedal button located on the front panel to active the Foot Pedal for suction. 3. When suction activation is required, press the Foot Pedal to deliver suction to the electrosurgical pencil. 4. To remove suction from the electrosurgical pencil via Foot Pedal control, release the Foot Pedal.

Definitions Symbols 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. SYMBOL

DEFINITION General warning sign New, empty SafeAir ULPA Filter

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SYMBOL

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DEFINITION Filled, used SafeAir ULPA Filter Electrosurgical pencil (Suction Activation) Directional Flow Stand-by button (ON/OFF)

Synchronization Sensor

Instructions Before First Use WARNINGS: ▪▪ ALWAYS operate the equipment within the specified environmental condition values: Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Foot Pedal receptacle Equipotentiality (See the Service section) Protective earth (ground) For Use With Type CF applied part Medical Device Keep away from sunlight

▪▪ If the machine has been stored or transported at temperatures below 10 °C or above 40 °C, allow it to acclimatize for approximately three hours at room temperature. 1. Remove the exterior packaging materials from the SafeAir Compact Smoke Evacuator and keep the original box and packaging material for potential future transportation.

Before the Procedure To Prepare the SafeAir Compact Smoke Evacuator WARNINGS:

Refer to instruction manual/booklet Direct Current (DC) Alternating Current (AC) USB port Type B (See the Service section)

Abbreviations ABBREVIATION COAG CUT EFUP EMC LED MPSO PSU PCB Compact ULPA USB

DEFINITION Coagulate Cut Environment Friendly Use Period Electromagnetic Compatibility Light Emitting Diode Multiple Portable Socket Outlets Power Supply Unit Printed Circuit Board Ultra Low Particulate Air Universal Serial Bus

▪▪ Before each use, inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. ▪▪ DO NOT operate the SafeAir Compact Smoke Evacuator with a damaged Power Cord or plug. ▪▪ DO NOT modify the Power Cord. ▪▪ ALWAYS position the equipment so that the Power Cord may be easily disconnected as required. ▪▪ ALWAYS wear gloves when manipulating contaminated filters. ▪▪ ALWAYS clean and disinfect the equipment as indicated upon initial receipt and before each use. See the Cleaning section. CAUTION: ALWAYS place the Power Cord where it will not be stepped on, tripped over, or otherwise subjected to damage or stress. NOTES: ▪▪ Make sure a SafeAir ULPA Filter is installed in the SafeAir Compact Smoke Evacuator before using smoke evacuation. ▪▪ Make sure the SafeAir Compact Smoke Evacuator is placed on a sturdy, flat surface.

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▪▪ If selecting the electrosurgical pencil or continuous suction activation modes and not using the Foot Pedal, then place the Foot Pedal in a safe and secure storage area to avoid potential deterioration. ▪▪ If electrical power is lost, the SafeAir Compact Smoke Evacuator adjustable settings, such as the Foot Pedal selection and operating modes, will revert to the default configuration or the last selected preset. Always verify the SafeAir Compact Smoke Evacuator settings before use.

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1. If using a Foot Pedal, secure the Foot Pedal input connector to Foot Pedal socket located at rear panel of SafeAir Compact Smoke Evacuator. See the To Install and Operate the Foot Pedal section. 2. Connect the Power Cord output connector to Power Supply Unit inlet socket. 3. Connect the power adapter output connector to the SafeAir Compact Smoke Evacuator at the rear panel. See the Features section.

Figure 6 – Eject Synchronization Sensor 11. Place the electrosurgical pencil cable onto the sensor tray cable channel and push the sensor tray back until the sensor tray locks. See Figure 7.

4. Insert and place the Power Cord connector to a hospital grade receptacle. 5. Press the On/Off button located at the front panel to enable power to the SafeAir Compact Smoke Evacuator. A green light LED will illuminate for confirmation. 6. Place the SafeAir ULPA Filter in the filter tray and push until the SafeAir ULPA Filter is fully inserted as shown in Figure 5. WARNING: If a SafeAir ULPA Filter is installed from a previous procedure, replace after one week of use or as indicated by the SafeAir Compact Smoke Evacuator. See the Indicator Lights section.

Figure 7 – Set up Synchronization Sensor

To Adjust the Synchronization Sensor The sensor sensitivity can be adjusted to optimize synchronization with the electrosurgical unit. The sensor reacts to current flow in the electrosurgical pencil cable and should be adjusted to the weakest signal of the two functions CUT and COAG. The blinking LED represents the sensitivity level of the sensor. The solid LEDs represent the signal strength from the electrosurgical unit.

Figure 5 – Filter Installation 7. If inserting a new filter, press the Reset button for 3 seconds on front panel to reset the timer. 8. Insert the tubing connector of the electrosurgical pencil into the filter inlet nozzle. 9. Synchronize the SafeAir Compact Smoke Evacuator with the electrosurgical unit via synchronization sensor tray or use alternative activation modes. NOTE: If selecting Continuous or Foot Pedal suction activation modes, then proceed to the During the Procedure section. 10. Press the synchronization sensor tray 1 and release 2 . See Figure 6.

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WARNING: DO NOT touch the electrode when adjusting the synchronization sensor. 12. Press the button in the suction activation mode selector for 3 seconds. 13. Verify the Time Delay function shows a single blinking LED. 14. Activate the suction with the COAG button on the electrosurgical pencil. 15. Verify the Time Delay function shows one or more solid LEDs. 16. Press the control buttons or blinking LED to the top solid LED.

to move the

17. Release the COAG button on the electrosurgical pencil. 9

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18. Activate suction with the CUT button on the electrosurgical pencil.

2. Disconnect any accessory devices and Power Cord from the SafeAir Compact Smoke Evacuator.

19. If the single blinking LED light is above the threshold of the solid LEDs, press the control buttons or to move the blinking LED to the top solid LED.

CAUTION: Disconnect the cord plug by grasping and pulling the connector only. DO NOT pull on the cord itself.

20. Release the CUT button on the electrosurgical pencil.

During the Procedure To Operate the SafeAir Compact Smoke Evacuator WARNINGS: ▪▪ Prior to activation of the SafeAir Compact Smoke Evacuator, the suction should be set on the low setting. When the unit is activated, check to ensure the smoke from the surgical site is completely evacuated by the suction. The time delay function should be set for the level of smoke generated (e.g., large volume = slightly longer delay). In the event the surgical smoke is not being cleared effectively, the suction can gradually be increased until the smoke is completely evacuated from the surgical site. Care should be taken to avoid suction coming in contact with tissue surfaces as powerful suction could damage to the surrounding tissues. ▪▪ Strong vacuum can be produced when activated on a high suction level. Prior to initiation of use, adjust the suction power to the lowest level whereby the smoke is evacuated with minimal impact (suction) on the surrounding tissues. 1. Select the required level of the vacuum suction power. 2. Select a suction activation mode. Use activation via button if you have synchronized the smoke evacuator with an electrosurgical unit.

3. Clean the equipment as indicated. See the Cleaning section for care information.

Cleaning WARNING: Before cleaning, turn off the unit and disconnect power cord. CAUTIONS: ▪▪ DO NOT immerse any component in liquid. ▪▪ DO NOT allow liquids or moisture to enter any electrical connection. ▪▪ DO NOT use solvents, lubricants, or other chemicals, including glutaraldehyde or similar chemical cleaners, unless otherwise specified. ▪▪ DO NOT allow water to collect on top of the SafeAir Compact Smoke Evacuator. ▪▪ DO NOT allow water to enter the cooling vents on the back of the SafeAir Compact Smoke Evacuator. ▪▪ DO NOT sterilize the SafeAir Compact Smoke Evacuator, Foot Pedal, cords, or cables. 1. Disconnect the Power Cord from facility power. 2. Place the SafeAir Compact Smoke Evacuator on a dry and clean surface. 3. Wipe all external surfaces of the equipment with a soft, lint-free cloth moistened with a non-abrasive, hospital disinfectant prepared according to the manufacturer’s instructions.

NOTES:

4. Upon the removal of visible gross soil, use a clean cloth moistened with disinfectant and wipe all surfaces. Surfaces must remain visibly wet at room temperature for at least the minimum time specified in the instructions for use supplied by the disinfectant manufacturer.

▪▪ Selecting time delay also ensures that smoke inside the tubing of the electrosurgical pencil is fully aspirated.

5. Remove any excess disinfectant solution using a soft, lint-free cloth moistened with water if required by the instructions supplied by the disinfectant manufacturer.

▪▪ Side covers may heat up after hours of continuous operation.

6. Visually inspect the equipment for any remaining soil or disinfectant solution. If soil or disinfectant solution remains, repeat the cleaning procedure using a fresh disinfectant solution.

3. During the procedure, ensure smoke from the surgical site is completely evacuated by suction. Depending on the surgical site and the amount of smoke generated, adjust the time delay function on the front panel.

After the Procedure To Shut Down the SafeAir Compact Smoke Evacuator 1. Turn the SafeAir Compact Smoke Evacuator off by pressing the Stand-by button. Confirm green LED light is not illuminated.

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7. Inspect the equipment for damage. See the Inspection and Maintenance section. 8. Place the SafeAir Compact Smoke Evacuator in the operation area or in storage for future use.

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Inspection and Maintenance WARNINGS: ▪▪ Upon initial receipt and before each use, check the equipment for proper function and verify cord and cable insulation is intact. ▪▪ DO NOT disassemble, modify, service, or repair this equipment without authorization of the manufacturer.

COMPONENT SafeAir Compact Smoke Evacuator Foot Pedal

Power Supply Unit and Power Cord

ACTION Preventative maintenance should be done at one year intervals for minor service and three year intervals for a major service. In the event that the equipment falls outside of specifications, contact Stryker. See the Service section for more information. Inspect the cord before each use and replace the Foot Pedal upon evidence of any deterioration. CAUTION: DO NOT store the Foot Pedal with the cord tightly wrapped around the pedal. Allow sufficient slack to prevent stress on the cord. Inspect the Power Supply Unit and Power Cord before each use and replace it upon evidence of deterioration. Poor contact between the Power Cord and input connectors can cause intermittent performance.

SafeAir ULPA Filter

YEAR OF USE SafeAir Compact Smoke Evacuator REF 0703-045-000

Badly oxidized surfaces can impede current flow. Use an abrasive cloth to gently clean plug surfaces to keep them clean and bright. Inspect the SafeAir ULPA Filter before use and replace the filter upon evidence of any deterioration or damage and when indicated by the product. In the event of liquids entering the filter, dispose of the SafeAir ULPA Filter immediately. See the Disposal/Recycle section.

1

st

a

a

X=One year service interval

b

O=Three year service interval

X

PERIODIC MAINTENANCE PLAN 2 3rd 4th nd

a

X

b

O

a

X

5th a

X

6th b

...

O

Storage and Handling CAUTION: ALWAYS transport and store the equipment within the specified environmental condition values: Temperature Limitation

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Humidity Limitation

Atmospheric Pressure Limitation

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Troubleshooting SYMPTOM The vacuum pump does not start.

POSSIBLE CAUSE Fuses are defective

Green LED light is not illuminating by the On/Off Stand-by button.

Power Supply Unit not connected to the SafeAir Compact Smoke Evacuator Power Supply Unit is faulty or damaged No electrical power is present from the Power Supply Unit

The vacuum pump does not start. The whole filter life display is blinking. After start-up all LEDs are blinking, the device does not respond in any way. All 10 LEDs of Vacuum Suction power indicator are blinking. All 10 LEDs of Time Delay indicator are blinking.

The vacuum pump will not start when the pencil is activated.

The vacuum pump will not stop when the electrosurgical unit is not active. The vacuum pump is running, but there is no or reduced suction capability.

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No power at hospital-grade, facility power receptacle There is no SafeAir ULPA Filter in the filter tray. As a security feature the pump cannot run without a SafeAir ULPA Filter

ACTION Contact Stryker. See the Contact Information section. Connect the Power Supply Unit to the SafeAir Compact Smoke Evacuator. Contact Stryker for a replacement Power Supply Unit. See the Contact Information section. Connect the output connector on the Power Cord to the Power Supply Unit inlet connector port. See the Features section. Check electrical service. Insert the SafeAir ULPA Filter into the filter tray. See the Before the Procedure section.

Power-on self-test failed

Contact Stryker. See the Contact Information section for Stryker service.

Lost communication between PCBs (Main board and Pump controller PCBs)

Contact Stryker. See the Contact Information section for Stryker service.

The SafeAir Compact Smoke Evacuator is overheating and is not cooling

Check if the cooling air vents are not blocked. If any blockage is present by the cooling air vents, remove the blockage.

The SafeAir Compact Smoke Evacuator is not synchronized with the electrosurgical unit The synchronization sensor does not record the signal Time Delay is at its maximum The synchronization sensor is too sensitive and reacts to electrical disturbances Exhaust tube is kinked

Check the fan airflow at the exhaust vent located underneath the SafeAir Compact Smoke Evacuator. If no airflow is present, then turn off the SafeAir Compact Smoke Evacuator to preventive further overheating. See the Contact Information section for Stryker service. Synchronize by following the instructions in the To Adjust the Synchronization Sensor section. Adjust sensitivity of the sensor. See the To Adjust the Synchronization Sensor section. Decrease Time Delay. Adjust sensitivity of the sensor. See the To Adjust the Synchronization Sensor section. Ensure the exhaust tube is straightened with no kinks.

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Service WARNING: DO NOT disassemble, modify, service, or repair this equipment without authorization of the manufacturer. CAUTIONS: ▪▪ ALWAYS comply with the specified one year and three year service intervals to ensure the safe and effective use of the equipment. The USB Type B port is only dedicated for use to the Stryker servicing department. Any additional equipment connected to SafeAir Compact Smoke Evacuator must comply with the respective IEC or ISO standards (e.g. IEC 60950 or IEC62368 for data processing equipment). Furthermore, all configurations shall comply with the requirements for medical electrical systems (see clause 16 of the latest valid version of IEC 60601-1). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. If in doubt, consult your Stryker sales representative or call Stryker customer service. ▪▪ Equipotential bonding involves the joining together of all metalwork and conductive items that are in the same potential (voltage) everywhere and is an important countermeasure in reducing the risk of equipment damage and personal injury. For additional information, refer to IEC 60601 series requirements for medical electrical systems. NOTES: ▪▪ The useful life of this equipment is dependent upon many factors including, but not limited to, the method and duration of each use, and the handling of the equipment between uses. ▪▪ Routine and careful inspection of the equipment is the best method for determining the serviceable life span of the equipment. ▪▪ Maintenance documentation for this equipment is available upon request to Stryker-authorized service personnel only. ▪▪ For service information, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary.

Disposal/Recycle WARNINGS: ▪▪ Follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the equipment at the end of its useful life. ▪▪ ALWAYS follow the current local regulations governing biohazard waste to safely handle and dispose of surgical waste.

SafeAir ULPA Filter ▪▪ The SafeAir ULPA Filter REF 0703-040-000 shall be disposed of in accordance with hospital policy.

SafeAir Compact Smoke Evacuator To comply with European Community Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/ EU, this device should be collected separately for recycling. DO NOT dispose of as unsorted municipal waste. Contact local distributor for disposal information. Ensure infected equipment is decontaminated prior to recycling.

Power Supply Unit and Power Cord To comply with European Community Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/ EU, this device should be collected separately for recycling. DO NOT dispose of as unsorted municipal waste. Contact local distributor for disposal information. Ensure infected equipment is decontaminated prior to recycling. Environment Friendly Use Period (EFUP) of ten years after manufacturing date, per China RoHS standard.

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Specifications Model: Catalog Number: Dimensions: Height: Width: Length: Mass: Mode of Operation: SafeAir Compact Smoke Evacuator Power Requirements: Input: Output: Ingress Protection (IP):

SafeAir Compact Smoke Evacuator 0703-045-000 5.51 in (140 mm) 14.96 in (380 mm) 11.81 in (300 mm) 27.77 Ibs (12.6 kg )+ 2.20 Ibs (1 Kg) (Power Supply Unit) Continuous Operation

100-240 V 2.2 A 50/60 Hertz (Hz) 24 V (Direct current), 175 W (7.5 A) IP 21, normal tight Type CF Applied Part

Equipment Type:

Class I Medical Electrical (ME) Equipment Protective Earth (ground); when connected to facility power receptacle

Ground Type: Power Consumption:

In operation: maximum 175 W

Standby:

35 W maximum suction at the filter inlet: approximately 110 L/min

Suction capacity:

maximum suction at the tip of electrosurgical pencil: 90 L/min ± 10% minimum suction at the tip of electrosurgical pencil: 40 L/min ± 10%

Vacuum:

approximately 550 mbar

Noise level:

46 dBa

Filter:

SafeAir ULPA Filter

Filtration efficiency:

99.999% at 0.1 μm

Filter life: Power Supply Unit: Input:

5 hours of total use or 1 week from initial use if less than 5 hours

Output:

24 VDC

Connector Type:

IEC320-C14

Means Of Protection:

2 x MOPP (Means of Patient Protection)

Environmental Rating:

IP22

Output Connector Type:

Equivalent to KPPX-4P

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100 - 240 VAC 2.2A, 50/60 Hz (Direct current), 7.5 A

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700000406523 Rev-AA

EN

Product Safety Certification ANSI/AAMI ES60601-1 CAN/CSA C22.2 No. 60601-1 IEC 60601-1 American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES60601-1:2005/(R) 2012 and A1: 2012, Medical Electrical Equipment - Part 1:General Requirements for Basic Safety and Essential Performance; Consolidated Reprint (2009); Amendment 2 (2010); 3rd Edition, 3.1, includes Amendment 1 (2012). Canadian Standards Association (CSA) CAN/CSA-C22.2 No. 60601-1:14, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance; (IEC 60601-1:2005+A1:2012, MOD)

Product Safety Compliance European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006+A12:2014, Ed: 3.1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); CENELEC Corrigendum (2010); CENELEC Amendment A11 (2011); IEC Amendment 1 (2013); IEC Corrigendum 3 (2014); CENELEC Amendment A12 (2014) International Electrotechnical Commission (IEC) IEC 60601-1:2012, Ed: 3.1, Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum2 (2007); Amendment 1 (2012) IEC 60601-1-6:2010+A1:2013, Ed: 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance – Usability IEC 62366:2007+A1:2014, Ed: 1.1, Medical Devices – Part 1: Application of Usability Engineering to Medical Devices

Electromagnetic Compatibility Guidance and manufacturer's declaration - electromagnetic emissions The SafeAir Compact Smoke Evacuator, REF 0703-045-000, is intended for use in the electromagnetic environment specified below. The customer or the user of the SafeAir Compact Smoke Evacuator REF 0703-045-000 should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

The SafeAir Compact Smoke Evacuator, REF 0703-045-000, use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A

NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radio frequency communication services. The user might need to take mitigation measures, such as relocating or reorienting the equipment.

CISPR 11 RF emissions CISPR 11 Harmonic emissions

Class A

IEC 61000-3-2

The SafeAir Compact Smoke Evacuator, REF 0703-045-000, is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Voltage fluctuations/flicker emissions IEC 61000-3-3

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Complies

WARNING: This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the SafeAir Compact Smoke Evacuator, REF 0703-045-000, or shielding the location.

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700000406523 Rev-AA

Electromagnetic Compatibility (continued) Guidance and manufacturer's declaration - electromagnetic immunity The SafeAir Compact Smoke Evacuator REF 0703-045-000 is intended for use in the electromagnetic environment specified below. The customer or the user of the SafeAir Compact Smoke Evacuator REF 0703-045-000 should assure that it is used in such an environment. NOTE: The values provided in the table below have changed due to 60601-1-2 4th Edition requirements. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD)

± 8 kV contact

± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 20%.

± 1 kV at 100 kHz repetition frequency for power supply lines

± 1 kV at 100 kHz repetition frequency for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

± 0.5 kV, ± 1 kV line(s) to line(s)

± 0.5 kV, ± 1 kV line(s) to line(s)

Mains power quality should be that of a typical commercial or hospital environment.

± 0.5 kV, ± 1 kV, ± 2 kV line(s) to earth

± 0.5 kV, ± 1 kV, ± 2 kV line(s) to earth

0% UT (100% dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0% UT (100% dip in UT) for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0% UT (100% dip in UT) for 1 cycle at 0°

0% UT (100% dip in UT) for 1 cycle at 0°

70% UT (30% dip in UT) for 25 and 30 cycles at 0°

70% UT (30% dip in UT) for 25 and 30 cycles at 0°

0% UT (100% dip in UT) for 250/300 cycles

0% UT (100% dip in UT) for 250/300 cycles

3 A/m at 50 and 60 Hz

30 A/m at 50 and 60 Hz

IEC 61000-4-2 Electrical fast transient/ burst IEC 61000-4-4 Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic fields

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SafeAir Compact Smoke Evacuator REF 0703-045-000 requires continued operation during power mains interruptions, it is recommended that the SafeAir Compact Smoke Evacuator REF 0703-045-000 be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8 NOTE: UT is the a.c. mains voltage prior to application of the test level.

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700000406523 Rev-AA

EN

Electromagnetic Compatibility (continued) Guidance and manufacturer's declaration - electromagnetic immunity The SafeAir Compact Smoke Evacuator REF 0703-045-000 is intended for use in the electromagnetic environment specified below. The customer or the user of the SafeAir Compact Smoke Evacuator REF 0703-045-000 should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Conducted RF

3 V 0.15 MHz – 80 MHz

3 V 0.15 MHz – 80 MHz

IEC 61000-4-6

6 V in ISM bands between 0.15 MHz and 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz

Radiated RF

b 10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz

b 10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz

27 V/m 385 MHz, pulse modulation 18 Hz, Maximum power = 1.8 W

27 V/m 385 MHz, pulse modulation 18 Hz, Maximum power = 1.8 W

28 V/m 450 MHz, FM ± 5 kHz deviation, 1 kHz sine, Maximum power = 2 W

28 V/m 450 MHz, FM ± 5 kHz deviation, 1 kHz sine, Maximum power = 2 W

9 V/m 710, 745, 780, 5240, 5500, 5785 MHz, pulse modulation 217 Hz, Maximum power = 0.2 W

9 V/m 710, 745, 780, 5240, 5500, 5785 MHz, pulse modulation 217 Hz, Maximum power = 0.2 W

28 V/m 810, 870, 930 MHz, pulse modulation 18 Hz, Maximum power = 2 W

28 V/m 810, 870, 930 MHz, pulse modulation 18 Hz, Maximum power = 2 W

28 V/m 1720, 1845, 1970, 2450 MHz, pulse modulation 217 Hz, Maximum power =2W

28 V/m 1720, 1845, 1970, 2450 MHz, pulse modulation 217 Hz, Maximum power =2W

IEC 61000-4-3

Electromagnetic environment - guidance WARNING: Portable RF equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the SafeAir Compact Smoke Evacuator REF 0703-045-000, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

(Non-ionizing electromagnetic radiation)

NOTE 1: At 80 MHz and 800 MHz the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SafeAir Compact Smoke Evacuator REF 0703-045-000 is used exceeds the applicable RF compliance level above, the SafeAir Compact Smoke Evacuator REF 0703-045-000 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SafeAir Compact Smoke Evacuator REF 0703-045-000. a

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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

2019-07

700000406523 Rev-AA

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