RAPIDSORB Injectable Polymer System (IPS) Instructions for Use

In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in craniofacial reconstruction (excluding the upper and lower jaw).

CONTRAINDICATIONS RAPIDSORB IPS is not intended for use in full load bearing applications. These devices are not intended for areas with active or latent infection, limited blood supply, or insufficient quantity or quality of bone. These devices are not intended for use in the spine.

WARNINGS General • The RAPIDSORB IPS is intended to be operated by clinically trained personnel qualified to participate in surgical procedures who are thoroughly familiar with the devices, the method of application, the instruments, and the surgical procedure. • The RAPIDSORB IPS is intended for use only with DePuy Synthes 1.5 mm RAPIDSORB plates, meshes, and sheets, and is not intended to be used with 2.0 mm RAPIDSORB plates, meshes, and sheets. • Do not sterilize or re-sterilize any components of the RAPIDSORB IPS except for the Sterility Shield. • Do not use to fixate metallic implants. • To ensure alignment of drilled holes with plate holes, do not drill multiple holes before the plate is positioned and fixated. • Take care not to damage the plate, mesh or sheet when drilling holes. • The Push Rod is magnetic. Keep away from loose metal objects. • While rare, implantation of foreign materials can result in an inflammatory response or allergic reaction. • The system should not be used adjacent to other electrical equipment. If it is necessary to use adjacent, the system should be observed to verify normal operation. • All sterile packed devices are intended for single use only. Contents are sterile unless inner package is open or damaged. For these items, do not use if previously opened. • Do not use if product or packaging is damaged upon receipt.

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PRECAUTIONS Intended Use • Use only with 1.5mm RAPIDSORB plates, meshes and sheets. • Use only the RAPIDSORB IPS 1.7 mm Drill Bits to ensure proper fixation. • The RAPIDSORB IPS is intended only for fixation of 1.5mm RAPIDSORB plates, meshes, and sheets to bone. The use of RAPIDSORB IPS to attach bone to bone has not been evaluated. • Use a minimum number of four fasteners (2 fasteners on each side of the defect) to ensure proper fixation. • Use only with RAPIDSORB IPS Battery Pack. • Use only with RAPIDSORB IPS Fastener Cartridges. • Use only with RAPIDSORB IPS Power Drive Unit. • Always follow aseptic technique when handling the device.

Environmental • The RAPIDSORB IPS is intended to be used only in an Operating Room Environment. • Do not use in the presence of flammable materials, to prevent the risk of fire. • Not suitable for use in the presence of flammable anesthetics, nitrous oxides, or oxygen rich environment. • Do not operate close to magnetic fields (e.g., MRI), due to risk of device malfunction. • Do not use RAPIDSORB IPS Fastener Cartridges if the temperature indicator located on the packaging is black.

Electrical • Electrical Shock Hazard. Do not immerse system or system components. (See Cleaning Instructions for the Power Drive Unit.) • Fire/Explosion Hazard. Do not recharge or resterilize. • Do not modify this equipment. • Do not disassemble the Power Drive Unit. • Do not disassemble the Battery Pack. • Do not attempt to recharge the Battery Pack

Patient & User • Do not assemble without Sterility Shield. Proper aseptic technique should be used when assembling to prevent device contamination.

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• Surface temperature at device tip may reach, but not exceed 100°C. Avoid prolonged contact (longer than 60 seconds) with this area to reduce exposure to temperatures and risk of burns.

• Consult local laws regarding proper recycling and disposal of system components.

ICONS & SYMBOLS OPERATIONAL ICONS & SYMBOLS LED Name LED Flash Symbol State Ready

Meaning

Solid On

System is ready

Flashing (after creating fastener)

Fastener formation complete

User Action (if any) Press Activation Button to dispense fastener Remove device from implant site

System is in Standby mode. Standby

Solid On

Low Battery

Flashing Solid On

Appears when: 1: System boots to Standby mode 2: System on for longer than 10 minutes without use. Battery Pack is at low power threshold Battery Pack must be replaced

Depress Activation Button to switch to Ready mode

Replace Battery Pack User to wait for Ready State (approximately 1 minute from startup or Standby) Reload RAPIDSORB IPS with the desired Fastener Cartridge size.

Heating

Flashing

System is adding heat to reach or maintain temperature.

Low Polymer

Solid On

Polymer empty.

Fastener Length

Solid On

Selected length of fastener to be dispensed (3 mm-8 mm)

No user action required

Caution/ Fault

Flashing

Indicates RAPIDSORB IPS requires user action

See troubleshooting

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REFERENCE SYMBOLS Description Conforms to ANSI/AAMI STD ES60601-1, UL STD 60601-1, IEC STDS 60601-1, 60601-1-6 & 62366 Certified to CSA STD C22.2 Nos. 601-1 & 60601-1 Type BF Applied Part, not suitable for direct cardiac applications. Note: Applied Part of this device is considered to be the metal tip at the front of the device and the portion of the plastic enclosure immediately near the tip (see assembly graphic). Single Use Only (Do not Re-use) Use By Date (Expiration Date, Expiry) Date of Manufacture Lot Number

REFERENCE SYMBOLS Description Do not dispose/see local regulations for disposal Operator to consult the Accompanying Documents.

CLEANING AND STERILIZATION Components Provided Sterile or Suitable for Sterilization The following item(s) are provided sterile unless inner package is opened or damaged. Do not re-sterilize. Components Provided Sterile Part Number 805.500S 805.505.01S 805.510.01S 805.520.01S 530.552S

Catalog Number Serial Number Sterilization by EO (Ethylene Oxide) Sterilization By Irradiation RAPIDSORB IPS Power Drive Unit: Do not Sterilize RAPIDSORB IPS Battery Pack: Do not Resterilize

530.555.01S 530.553.01S 310.403S 310.404S 310.405S 310.406S 310.407S 310.408S

Description

Sterilization Method

DePuy Synthes RAPIDSORB Gamma IPS Fastener Cartridge Irradiated DePuy Synthes RAPIDSORB IPS Shell and Cap DePuy Synthes RAPIDSORB IPS Replacement Cap DePuy Synthes RAPIDSORB IPS Battery Pack

Ethylene Oxide (EO) Gamma Irradiated

RAPIDSORB IPS 1.7 mm Drill Gamma Bit (3 mm–8 mm lengths) Irradiated

Upper and Lower Limit of Temperature

The RAPIDSORB IPS Sterility Shield is provided non sterile and is suitable for sterilization by the end user.

Lock

Components Provided Non-Sterile, Sterilized by End User Part Number Description 530.554 RAPIDSORB IPS Sterility Shield Sterilization Method Method Cycle Minimum Minimum Minimum Tempera- Exposure *Dry ture Time Time Steam Pre-vacuum 132°C 4 20 (Wrapped) (270°F) Minutes Minutes

Caution Fire Hazard. Not suitable for use in the presence of flammable anesthetics or Oxygen. Do not immerse

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These parameters are validated to sterilize only these devices. The manufacturer’s validated sterilization parameters and the autoclave manufacturer’s operating instructions should be followed. The autoclave must be properly installed, maintained, and calibrated. Only legally marketed, FDA cleared sterilization wrap, pouches, or containers should be used by the end-user for packaging terminally sterilized devices. The manufacturer’s instructions for use for the sterilization wrap, pouches, or containers are to be followed.

Care should be used not to bend or damage the electrical contact pins. After wiping down, allow the Power Drive Unit to air dry for approximately 15 minutes before re-use or storage, or it can be dried using a soft, lint-free clean cloth.

* DePuy Synthes Companies recommends a minimum dry time of 20 minutes for this device when sterilized using the parameters recommended above. However, because dry time can be influenced by various factors such as autoclave performance, sterilization load, sterilization wrap/package materials, steam quality, varying cool-down time, and environmental conditions, adequate drying of this device should be verified by visual inspection.

Service immediately if the Power Drive Unit is found to be damaged or you suspect that the Power Drive Unit is malfunctioning.

Non Sterile Components Not Suitable for Sterilization The Power Drive Unit is provided non-sterile and is not suitable for sterilization. Components Provided Non-Sterile, Used Non Sterile Part Cleaning Number Description Method Not suitable for sterilization. 530.551 Power Drive Unit See cleaning instructions below

CLEANING OF POWER DRIVE UNIT • DO NOT IMMERSE OR STERILIZE THE POWER DRIVE UNIT. • Because the Power Drive Unit does not have patient contact and does not contact bodily fluids, due to it being contained within the sterile IPS Shell and Cap during normal use, please see REPAIR AND PREVENTATIVE MAINTENANCE for wipe down instructions.

Important DO NOT SPRAY, IMMERSE OR STERILIZE THE POWER DRIVE UNIT.

SERVICE AND PREVENTATIVE MAINTENANCE

The RAPIDSORB IPS has no user-serviceable parts. The RAPIDSORB IPS Power Drive Unit is a precision tool which requires periodic service to ensure performance according to specification. It is recommended that the Power Drive Unit [PN 530.551] be serviced once every 12 months.

Please contact DePuy Synthes Repair Department to obtain authorization and instructions for sending the unit in for repair or service. Return Address: Repair Department DEPUY SYNTHES 1101 Synthes Avenue Monument, CO 80132 800-327-6887, option 2

TECHNICAL DATA ELECTRICAL DATA (Assembled Device) Battery voltage Battery type

15 VDC Lithium Manganese Dioxide

Environmental Conditions For Use Temperature Relative Humidity Atmospheric Pressure Elevation Weight (Assembled)

18 – 23°C (64.4 – 73.4°F) 15% – 85%, Non-condensing 645 – 795 mm Hg (12.5 – 15.4 psi) 2000m Max. 0.53 kg. (1.17 Lbs.) Approx.

Storage Conditions Temperature Relative Humidity Atmospheric Pressure Elevation Weight (Assembled)

5 -25°C (41 – 77°F) 15%-85% , Non–condensing 645 – 795 mm Hg (12.5 – 15.4 psi) 2000m Max. 0.53 kg. (1.17 Lbs.) Approx.

After use, the Power Drive Unit should be wiped clean with a damp cloth using a soap and water solution. Solvents and aggressive chemicals should not be used to clean the unit.

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ASSEMBLY RAPIDSORB IPS Delivery Device The RAPIDSORB IPS Delivery Device components are labeled below:

Important: To maximize battery life, RAPIDSORB IPS should be assembled and powered up about 15 minutes prior to its use.

Unpacking Circulating (non-sterile) person 1. Open Starter Kit carton and remove the Starter Fastener Cartridge and the tray-packaged Shell and Cap. 2. Open the outer tray to allow the inner tray to be retrieved by the scrubbed person. 3. Open the sterile pouch containing the foil-packed Fastener Cartridge and allow the scrubbed person to retrieve the foil pouch. Assembly Scrubbed (sterile) person 1. Remove the sterile Shell and Cap from the sterile tray. 2. Press the Push Rod fully forward on the RAPIDSORB IPS Device until it stops. Hold the Shell with the tip pointing down. Position the Sterility Shield securely over the round opening in the back of the device. Circulating (non-sterile) person 3. Align orange line on the Power Drive Unit with orange mark on the inside rim of the Shell. Insert the Power Drive Unit straight into the Shell. Do not rotate the Power Drive Unit after insertion. Note: When seated, the top portion of the NON-STERILE Power Drive Unit will extend beyond the Shell. 4. Hold the upright tabs of the Sterility Shield and carefully remove it from the Shell to avoid contamination.

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Scrubbed (sterile) person 5. Align the green markings on the Cap and Power Drive Unit. Place the Cap over the exposed Power Drive Unit. Important: • Do not allow the NON-STERILE Power Drive Unit to contact the exterior portion of the STERILE Shell and Cap. • If Cap sterility is compromised, a Replacement Cap is available [PN 530.555.01S] 6. Push the Cap down and turn clockwise until the green markings align with the Lock symbol [ ] on the Shell. 7. Insert Battery Pack into handle in the orientation shown. Battery Pack must be fully seated. Low Polymer and Standby icons will illuminate. Loading Fastener (Starter) Cartridge Scrubbed (sterile) person 1. Press the Release Lever forward and hold with one hand while pulling back the Push Rod with the other hand until it stops and the etched ring on the base of the Push Rod is visible. Important: • Be certain that the Push Rod is fully pulled back and etched ring is visible before adding polymer • Be careful not to push the Activation Button during the loading process. 2. Using the Fastener (Starter) Cartridge included in the Starter Kit, insert the tip of the Fastener Cartridge into the Fastener Cartridge Port on the Shell and push only the ribbed portion of the Fastener Cartridge forward until the polymer is inserted into the device. Important: • Ensure Fastener Cartridge is fully collapsed and all polymer rods are inserted into the device. 3. Remove and discard empty Fastener Cartridge and manually advance the Push Rod until it stops. Priming Device Scrubbed (sterile) person The RAPIDSORB IPS must be primed after loading polymer into the device and prior to inserting a fastener. 1. Set the Fastener Length to 4 mm using the Fastener Length Dial on the Cap. 2. Press the Activation Button once on the handle to bring the device out of Standby [ ] mode to Ready [ | ] mode and start heating the polymer. The Heating icon [ ] will begin flashing. Wait until the Heating icon turns off and the green Ready icon [ | ] illuminates. The device is ready to be primed. 3. Press and release the Activation Button once to start the fastener formation cycle. Repeat until polymer is expelled from the tip. Remove excess polymer with sterile gloved fingertips and discard excess polymer. Replace sterile glove if damaged during excess polymer removal. Caution: Surface temperature at device tip may reach 100°C. Avoid prolonged contact (longer than 60 seconds) with this area to reduce exposure to temperatures and risk of burns.

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Starter Cartridge Fastener Production The quantity of fasteners produced will vary depending on length of fasteners being implanted. The fastener length can be adjusted with the Fastener Length Dial on the Delivery Device Cap. See the table below for approximate quantities. Approximate Quantity of Fasteners Produced By Starter Cartridge* After Device is Primed Fastener Length

3 mm 4 mm 5 mm 6 mm 7 mm 8 mm

Approximate Quantity of Fasteners Produced

16

14

11

10

8

7

* Starter Cartridge is included in the RAPIDSORB IPS Device Starter Kit Note: If reloading the device with additional Fastener Cartridges, please see table in the Intra-Operative Polymer Reloading section of this document for approximate fastener quantities.

OPERATING INSTRUCTIONS Note: For complete technique tips of thermally contouring RAPIDSORB plates, sheets, and meshes see the RAPIDSORB Rapid Resorbable Fixation System Technique Guide. Forming Fasteners 1. Select the appropriate RAPIDSORB IPS 1.7 mm Drill Bit according to Desired Hole Depth. Important: Fastener length should be set according to the depth of the drill hole created and plate thickness. Refer to the image and table below for depth information.

Depth Below Mesh/Plate

Depth Depth Below Below 0.25mm 0.5 mm Thick Drill Bit Thick Mesh Mesh Φ1.7 x (mm) (mm) __ mm 3 4.05 3.80 4 5.05 4.80

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Depth Below 0.8 mm Thick IPS Fastener Length Dial Plate Setting* (mm) 3.50 3 4.50 4

Depth Depth Below Below 0.25mm 0.5 mm Thick Drill Bit Thick Mesh Mesh Φ1.7 x (mm) (mm) __ mm 5 6.05 5.80 6 7.05 6.80 7 8.05 7.80 8 9.05 8.80

Depth Below 0.8 mm Thick IPS Fastener Length Dial Plate Setting* (mm) 5.50 5 6.50 6 7.50 7 8.50 8

* Note: These represent Fastener Length Dial Settings for blind holes:

| Blind Hole Insertion For through holes, selecting a longer length setting will produce a bolus of polymer on the underside of the bone. This can improve fastener retention in areas of thin or dense bone.

| Bolus Insertion Caution: When in the cranium, place a narrow brain ribbon retractor between the inner cortical surface and the dura to prevent potential contact between the drill bit and the dura. 2. Place drill bit in appropriate drill with J-latch coupling that provides an optimal speed of 1,800 rpm. 3. Prior to powering drill, ensure that drill bit is secured in J-latch coupling. 4. While maintaining the drill bit perpendicular to the bone surface, drill through the plate/mesh hole or sheet and into the bone until the drill bit stop contacts the plate/ mesh/sheet surface. Irrigation while drilling is important to reduce risk of excessive drill bit wear and thermal necrosis to the bone. Important: • Irrigation is recommended when drilling hole. • Take care not to damage plate while drilling hole. • Remove any bone chips or debris which may have collected in the hole and clean flutes of debris before drilling the next hole 5. Turn the Fastener Length Dial on the Delivery Device Cap to the desired fastener length. The illuminated blue digit above the Fastener Length Dial indicates the fastener length (3 mm – 8 mm). Important: Fastener length should be set according to the depth of the drill hole created and plate thickness. Refer to the image and table above in step 1 for depth information.

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6. Align the Device Tip through the plate hole and into the pre-drilled hole. Press against plate with light pressure. 7. While keeping the device perpendicular to the plate surface, press and release the Activation Button once to form a fastener. Hold the device in place until the device has completed the fastener formation cycle while maintaining light pressure against the plate. Note: The completion of the fastener formation cycle is indicated when the green Ready icon [ | ] blinks 4 times and then remains illuminated. Do not remove the device before this cycle is complete. 8. After the fastener is formed, and while keeping the device perpendicular to the plate, remove the device from the point of fixation. Note: If desired, the fastener head may be smoothed by pressing down on it with sterile gloved finger immediately after removing the device. Note: The device may momentarily enter a Heating [ ] state as indicated by the icons on the back but should quickly return to Ready [ | ] state. 9. Repeat the process until the plate has been adequately fixated. A minimum of 2 fasteners on each side of the defect are necessary for fixation. Important: Plate manipulation should be avoided until fastener has solidified.

Intra-Operative Polymer Reloading 1. Additional Fastener Cartridges may be added to refill the device with polymer if required to complete the procedure. ] will be illuminated to indicate The Low Polymer icon [ when additional polymer is needed. Note: The shaded region on the end of the Push Rod provides a visual indication of when the need to reload is approaching.

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Important: Reloading with polymer prior to this point could lead to overfilling, resulting in damage to the device.

2. See table below for guidance on choosing Fastener Cartridge size according to length and quantity of fasteners required. Approximate Quantity* of Fasteners Produced By Cartridge Size By Fastener Length 3 4 5 6 7 8 Fastener Length mm mm mm mm mm mm 805.505.01S – RAPIDSORB IPS 1.5mm 5 5 4 3 3 2 Fastener Cartridge, small – Sterile 805.510.01S – RAPIDSORB IPS 1.5mm 12 10 8 7 6 6 Fastener Cartridge, medium – Sterile 805.520.01S – RAPIDSORB IPS 1.5mm 25 21 18 15 13 12 Fastener Cartridge, large – Sterile * These quantities are accurate when reloading a device that has previously been used to insert fasteners. 3. Refill the device with polymer according to the loading instructions described above. Important: • Do not add additional polymer until Low Polymer icon [ ] is illuminated. • Be certain that the Push Rod is fully pulled back and etched ring is visible before adding polymer. • Be careful not to push the Activation Button during reloading process. 4. Device must be re-primed following Polymer Reloading by pressing and releasing the Activation Button once to start the fastener formation cycle. Repeat until polymer is expelled from the tip. Remove excess polymer with sterile gloved finger tips and discard (as above).

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Intra-Operative Battery Pack Replacement

Disassembly

1. Additional Battery Packs may be required. Remove the Battery Pack by simultaneously pressing the Release Buttons on both sides of the handle while pulling downward on the Battery Pack. 2. Insert a new sterile Battery Pack into the device according to Assembly instructions described above.

Important: The device must be disassembled prior to disposal. 1. Remove the Battery Pack by simultaneously pressing the Release Buttons on both sides of the handle while pulling downward on the Battery Pack. 2. Hold the device with the tip pointed down. Turn the Cap on the back of the RAPIDSORB IPS device counter-clockwise to detach. Dispose of the Cap. 3. Lift the Power Drive Unit out of the Shell. Dispose of the Shell. 4. Wipe down the Power Drive Unit according to the Service and Preventative Maintenance instructions. 5. Return the Power Drive Unit to the case for storage.

Standby Mode • The device will revert to Standby [ ] after 10 minutes of non-use. Restore to Ready [ | ] state by pressing the Activation Button one time and allowing the device to warm. Note: When not using the device, it may be laid on its side. Do not rest the unit upright on the Battery Pack/handle as device will tip over.

Emergency Fastener Removal To remove a fastener, the fastener may be drilled out using the appropriate length 1.7mm diameter drill bit. Important: Take care not to damage plate hole when drilling into fastener. Visually inspect plate for damage. If plate is damaged, a new plate should be used.

TROUBLESHOOTING Caution/Fault Icon is Flashing LED Symbol LED Flash State Single Flashing (1 Flash every 4 seconds) Double Flashing (2 Flashes every 4 seconds)

!

Caution / Fault

Disposal Important: • Used Fastener Cartridges, Drill Bits, Delivery Device Shell and Delivery Device Cap should be treated as biological hazards and disposed of according to local laws and regulations for like devices. Dispose of worn drill bits in an appropriate sharps container. • The Battery Pack should be disposed of according to local laws and regulations concerning single-use lithium metal battery cells.

Possible Cause

User Action Remove and reinsert Battery Pack. Motor Time Out Error If issue persists replace Shell and Power Drive Unit. Ensure Cap is fully locked. Temperature is not increasing If issue persists replace Shell and Power Drive Unit. Ensure that there is no damage, debris, or excess Temperature is Triple Flashing fluid on the tip area of the device. If so remove with increasing but not sterile wipe. getting to required (3 Flashes every 4 seconds) temperature. If issue persists replace Shell and Power Drive Unit. Ensure Cap is fully locked. If issue persists, remove Battery Pack and wait Quadruple Flashing Temperature is too high, for a minimum of 10 minutes and then reinsert over temp (4 Flashes every 4 seconds) Battery Pack. If issue persists replace Shell and Power Drive Unit.

Electromagnetic Compatibility EMC information, provided in these Instructions for Use, is in accordance with EN/IEC 60601-1-2, clause 5.2.2. The RAPIDSORB Injectable Polymer system is a battery operated device and does not require any additional cables, transducers or other accessories other than those specified. 2021-05-13 04:14:34

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Table 1 – Guidance and Manufacturer’s Declaration – Emissions All ME Equipment and ME Systems Guidance and Manufacturer’s Declaration – Emissions The RAPIDSORB IPS is intended for use in the electromagnetic environment specified below. The customer or user of the RAPIDSORB IPS should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment – Guidance RF Emissions Group 1 RAPIDSORB IPS uses RF energy only for its internal function. Therefore, its RF emissions CISPR 11 are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions Class B The RAPIDSORB IPS is suitable for use in all establishments, other than domestic, and CISPR 11 those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonics N/A IEC 61000-3-2 Flicker N/A IEC 61000-3-3

Table 2 – Guidance and Manufacturer’s Declaration – Immunity All ME Equipment and ME Systems Guidance and Manufacturer’s Declaration – Immunity RAPIDSORB IPS is intended for use in the electromagnetic environment specified below. The customer or user of the RAPIDSORB IPS should ensure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic Environment – Guidance Test Level Level ESD ±6kV Contact ±6kV Contact Floors should be wood, concrete or ceramic tile. If floors IEC 61000-4-2 are synthetic, the r/h should be at least 30% ±8kV Air ±8kV Air EFT IEC 61000-4-4 Surge IEC 61000-4-5 Voltage Dips/ Dropout IEC 61000-4-11

±2kV Mains ±1kV I/Os ±1kV Differential ±2kV Common >95% Dip for 0.5 Cycle 60% Dip for 5 Cycles 30% Dip for 25 Cycles >95% Dip for 5 Seconds

Power Frequency 3A/m 50/60Hz Magnetic Field IEC 61000-4-8

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N/A

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

N/A

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

N/A

Mains power quality should be that of a typical commercial or hospital environment. If the user of RAPIDSORB Injectable Polymer System requires continued operation during power mains interruptions, it is recommended that the RAPIDSORB Injectable Polymer System be powered from an uninterruptible power supply or battery. Power frequency magnetic fields should be that of a typical commercial or hospital environment.

N/A

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Table 4 – Guidance and Manufacturer’s Declaration – Immunity ME Equipment and ME Systems that are NOT Life-supporting Guidance and Manufacturer’s Declaration – Immunity RAPIDSORB IPS is intended for use in the electromagnetic environment specified below. The customer or user of the RAPIDSORB IPS should ensure that it is used in such an environment. IEC 60601 Compliance Immunity Test Test Level Level Electromagnetic Environment – Guidance Portable and mobile communications equipment should be separated from the RAPIDSORB IPS by no less than the distances calculated/listed below: D=(3.5/V1)(Sqrt P) 150kHz to 80MHz D=(3.5/E1)(Sqrt P) 80 to 800 MHz Conducted RF 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz N/A D=(7/E1)(Sqrt P) 800 MHz to 2.5 GHz Radiated RF 3 V/m E1=3V/m where P is the max power in watts and D is the IEC 61000-4-3 80 MHz to 2.5 GHz recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter.

Table 6 – Recommended Separation Distances between portable and mobile RF Communications equipment and the RAPIDSORB Injectable Polymer System ME Equipment and ME Systems that are NOT Life-supporting Recommended Separation Distances for the RAPIDSORB Injectable Polymer System RAPIDSORB IPS is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the RAPIDSORB IPS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the RAPIDSORB IPS as recommended below, according to the maximum output power of the communications equipment. Separation (m) Separation (m) Separation (m) 150kHz to 80MHz 80 to 800MHz 800MHz to 2.5GHz Max Output Power (Watts) 0.01 0.1 1 10 100

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D=(3.5/V1) (Sqrt P) 0.11667 0.36894 1.1667 3.6894 11.667

D=(3.5/E1) (Sqrt P) 0.11667 0.36894 1.1667 3.6894 11.667

D=(7/E1) (Sqrt P) 0.23333 0.73785 2.3333 7.3785 23.333

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CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Manufactured or Distributed by: Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132 Telephone: (719) 481-5300 To order: (800) 523-0322 Fax: (800) 796-8437

Synthes GmbH Luzernstrasse 21 4528 Zuchwil, Switzerland +41 32 720 40 60

www.depuysynthes.com Note: For recognized manufacturer, refer to the product label.

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