Positioning Chair Users Guide part of the Osborn Medical/ACS Ven-View Vascular System

1. Positioning Chair Users Guidepart of the Osborn Medical/ACS Ven-View Vascular System Advanze Cardio Systems, Inc.Confidential

2. Positioning Chair Users Guide • Table of Contents/Guide Sections • 1-0: General Information • 1-1 Introduction • 1-2 Preparing to use the Product • 1-3 General Safety Notices • 1-4 User Safety • 1-5 Operator Requirements • 1-6 Mechanical, Electrical and Safety Certifications • 1-7 Warranty • 1-8 Return Policy • 2-0: Description and Features • 2-1 Product Description • 2-2 Positioning Chair Features • 3-0: Specifications • 3-1 Dimensions, Capacity, Safety and Power Advance Cardio Systems, Inc.Confidential

3. Positioning Chair Users Guide • Table of Contents/Guide Sections (continued) • 4-0: Setup/Patient Loading and Unloading • 4-1 Mains Connection and Power • 4-2 Patient Loading • 4-3 Patient Unloading • 4-4 Positioning Chair Parts Overview • 5-0: Maintenance/Cleaning/Troubleshooting • 5-1 Preventative Maintenance • 5-2 Cleaning and Disinfection • 5-3 Troubleshooting Advanze Cardio Systems, Inc.Confidential

4. Positioning Chair Users Guide • 1-0: General Information • 1.1 Introduction • Prior to operating this product, read and understand this User Guide along with any additional instructions provided by the manufacturer. Review and follow all Danger, Warning and Caution Notices to avoid injury to operator and occupant and damage to the product. • Keep this User Guide and instructions with this product for future reference. Operators need to become familiar with this product before using. Safety is the most important element of any procedure. Knowledge and safe working habits are essential to preventing death, personal injury, or property damage. Use the following statements as a common-sense guide to proper work and equipment use habits. • 1.2 Preparing to Use This Product • Preparation is essential to complete a procedure in a safe and efficient manner. • Always use proper personal protection equipment to prevent potential hazards. • Follow all procedures in this User Guide. Never take shortcuts. • Be prepared for emergencies. Accidents can happen, even under the best conditions and with the best preparation. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

5. Positioning Chair Users Guide • 1.3 General Safety Notices • Throughout this User Guide, the following key safety notices will be used to alert the reader of potential hazards. Become familiar with these notices and their meaning. Take all precautions to avoid the hazards described. This safety alert symbol is used to alert you to potential hazards Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

6. Positioning Chair Users Guide • 1-4 User Safety • Avoid a potentially hazardous situation. Always follow procedures and safety warnings. • Always apply wheel locks when using the Positioning Chair. • Never leave a patient on the Positioning Chair unattended. The chair may tip or move, resulting in serious injury of death to the patient. • Keep hands, fingers and feet on the Positioning Chair’s armrests and away from all moving parts and possible pinch points. Contact with moving parts and possible pinch points may result in injury to the patient or operators. • Reduce the risk of Bloodborne Pathogens:always clean and disinfect the chair properly. Failure to clean and disinfect properly may result in injury to patients and/or operators. • Always follow cleaning and disinfection instructions as explained in this User Guide for cleaning the Positioning Chair. • WARNING: If incorrectly used this product can cause severe injury. Those who use and maintain it should be trained in its proper use, warned of its dangers and should read the entire manual before attempting to set up, operate or adjust this product. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

7. Positioning Chair Users Guide • 1-4 User Safety (continued) • Any misuse of the Positioning Chair may result in injury and damage to the product, and will void any warranty. • The product should be operated only from the type of power source indicated in this Users Guide • Do not use this product near water or a heat source such as a radiator. • Openings in the computer (if provided) and in the back electrical box are provided for ventilation. Do not block or cover these openings. • This product is equipped with a three-wire power cord to make sure that the product is properly grounded when in use. The plug on this cord will fit only into a grounding-type outlet. This is a safety feature. • Do not use an extension cord with this product. Plug the supplied power cord directly into a three-wire wall outlet. • Do not walk on the power cord or allow anything to rest on it. • When the system is turned off, a small amount of electrical current still flows through the system. To avoid electrical shock, always unplug all power cables from the wall outlets before cleaning the system. • Class I, type B equipment. Not suitable for use with flammable anesthetics, continuous operation and/or ordinary equipment Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

8. Positioning Chair Users Guide • 1-5 Operator Requirements • Safety is the most important element of any procedure. Knowledge and safe work habits are essential to preventing death, personal injury or property damage. • Only properly trained personnel should be permitted to operate this product. • A skilled operator should have a complete understanding on the following patient handling procedures: • Patient positioning/moving patients • Familiarity with automated, electrical medical equipment • Patient assessment • Loading and unloading patients from automated medical equipment (such as hospital beds, wheel chairs) • An understanding of how the Positioning Chair works Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

9. Positioning Chair Users Guide • 1-6 Mechanical, Electrical and Safety Certifications • The Positioning Chair complies with test for Electrical Safety in accordance with IEC 60601-1. • The Positioning Chair complies with testing for EMC Emissions and Immunity in accordance with IEC 60601-1-2:2007 and is rated Class A for EMC (commercial/clinical environments, not residential use): • Radiated emissions • Conducted emissions • Flicker • Harmonics • ESD • Radiated immunity • EFT • Surge • Conducted immunity • Magnetic field immunity • Voltage drops • Voltage interruptions Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

10. Positioning Chair Users Guide • RoHS Compliance • All parts and components used in the design of the Positioning Chair meet RoHS Directive 2002/95/EC unless otherwise stated by the manufacturer. • IPX (Water Ingress) Rating • The Positioning Chair is considered to have an IPX2 rating in accordance with ANSI/IEC 60529:2004 Degrees of Protection Provided By Enclosure (IP Codes) and should never be subjected to water jet hose spraying or aggressive spraying of any kind to clean. This rating is applicable to the provided foot control, but not occlusion and sensing pressure cuffs or accessories used with the product and not authorized by the manufacturer. • 1.7 Warranty • Advanze Cardo Systems (ACS) warrants to the original purchaser that its products should be free from manufacturing non-conformances that affect product performance and customer satisfaction for periods as defined below for the Positioning Chair: • 6 months from purchase: parts and labor covered • 3 years from purchase: parts covered (only) Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

11. Positioning Chair Users Guide • Advanze Cardio Systems’ obligation under this warranty is expressly limited to supplying replacement parts and labor for, or replacing, at its own option, any product that is, in the sole discretion of Advanze Cardio Systems, found to be defective. Any improper use or alteration or repair by unauthorized service providers in such a manner as is Advanze Cardio Systems’ judgment affects the product materially and adversely, shall void this warranty. Any repair of Advanze Cardio Systems’ products using parts not provided or authorized by Advanze Cardio Systems shall void this warranty. No employee or representative of Advanze Cardio Systems is authorized to change this warranty in any way without the approval of the Company President. This statement constitutes Advanze Cardio Systems’ entire warranty with respect to the aforesaid product and associated parts and components. • ADVANCE CARDIO SYSTEMS MAKES NO OTHER WARRANTY OR REPRESENTATION, EITHER EXPRESSED OR IMPLIED, EXCEPT AS SET FORTH HERIN. THERE IS NO WARRANTY OF MERCHANTABILITY AND THERE ARE NO WARRANTIES OF FITNESS FOR ANY PARTICULAR PURPOSE. IN NO EVENT SHALL ADVANZE CARDIO SYSTEMS BE LIABLE HEREUNDER FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING FROM OR IN ANY MANNER RELATED TO SALES OR USE OF ANY SUCH EQUIPMENT OR PRODUCT. • 1.8 Return Policy • Product cannot be returned without an authorization number provided by ACS’ Customer Service department. Please call 1-507-932-5028. • Unused and undamaged product, along with accessories, may be returned up to 30 days of shipment. Custom or modified product is not subject to return. All product must be returned in the original packaging for the return policy to be effective and receive an RMA number before shipment back to the Company. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

12. Positioning Chair Users Guide • Damaged Product • Claims for damaged product must be made within 5 days of receipt. Short shipment claims must be made within 15 days of receipt. Notification to ACS under ICC Regulations outlined above result in a freight bill claim issued to the appropriate carrier for damage incurred, not to exceed actual replacement cost. In the event ACS is not within the guideline above, the customer will be responsible for the original invoice in full. • 2-0: Description and Features • 2.1 Product Description • The ACS Positioning Chair is designed with both patient and operator in mind. Helping to reduce back injuries, the product is used to position a patient during patient assessment. • The Positioning Chair may be used with the Ven-View Examination Module as part of the Ven-View System, or as a standalone option for other areas of patient assessment as determined by the healthcare provider. • Whether used with or without the Ven-View Examination Module, the Positioning Chair provides hands-free, ergonomically sound patient movement from a sitting position to supine and everywhere in between. • A description of the main Positioning Chair parts are found in section 4 of this User Guide. • 2.2 Positioning Chair Features • While the ACS Positioning Chair is simple to use, the product contains many valuable features for the user. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

13. Positioning Chair Users Guide • Large Backrest and Footrest • Unlike other patient assessment positioning chairs, the ACS Positioning Chair utilizes a large back cushion to accommodate larger patient size and weight. In fact, the ACS Positioning Chair has been tested for patient load up to 400 lbs. • Footrest Adjustment to Flat • The Positioning Chair has the ability to be affixed in a completely flat (lying) position. As shown in the figure below, simply pull on the T-bar handle labeled “Pull to Lay Flat” to position the chair. • When the T-bar is pulled back, this will allow the main “leg” to be released from its holding notch and position in a flat orientation. Support legs will comedown from under the footrest when in this position. ALWAYS MAKE SURE THAT MAIN LEG “PINS” ARE NOTCHED BEFORE LOADINGPATIENT! FOOT REST SHOULD NEVER BE USED TO SUPPORT A PERSON’S WEIGHT! DO NOT SIT ON THE FOOT REST AT ANY TIME! Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

14. Positioning Chair Users Guide • Footrest Adjustment Based on Patient Length • A unique product feature is the ability to adjust the footrest to accomodate various patient height. As shown in the figure below, once the product is moved to the flat position, pull on the T-bar handle labeled “Pull to Adjust Foot Rest Position.” The footrest will slide toward and away from the user for perfect patient positioning. To minimize injury, keep hands away from footrest adjustment mechanism. • Complete Patient Access • The ACS Positioning Chair has been designed to provide full access to the lower extremities (under legs, calves, ankle region) which is often required for complete patient assessment. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

15. Positioning Chair Users Guide • Hands Free Control • Movements for the ACS Positioning Chair are done using the provided foot control. Please note that there are two directional modes for the foot control: Lay Down and Sit Up. • The Lay Down position takes the product from a sitting position to a laying down or flat (supine) position. This motion leans back the back cushion and raises the foot rest. • The Sit-Up position takes the product from the Lay Down position to an upright or sitting position. This motion raises the back rest cushion and lowers the foot rest. • When moving the Positioning Chair from the sitting to supine position (Lay Down) and back to Sit Up, ensure the following: • All hands, fingers, head and feet are cleared from product movements. • The patient is situated on the Positioning Chair and is warned about movement and direction before product moves from a stopped position. • PLEASE CONSIDER ALL SAFETY LABELING before operating this product. The following labels are used on the Positioning Chair and should be referenced before operation to ensure safety to user and patient. • When moving the Positioning Chair, ensure feet are cleared from the wheels to avoid crushing. The label below provides a warning on all product wheel/caster areas: Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

16. Positioning Chair Users Guide • The main product “leg” which resides under the seat cushion while in the upright position will contact the area under the seat cushion. DO NOT PLACE HANDS OR FINGERS UNDER THE SEAT CUSHION AT ANY TIME to avoid pinching and digits being crushed! The label below resides on the product “leg” area and shows where this pinch/crushing location is. • In the same location under the seat cushion is a sensing bumper. If hands and fingers happen to be located under the seat cushion when the product moves from a sitting to lying down position, the sensing edge will shut off the power supply (and motor) to the actuator, stopping chair movement. To reset the sensing edge, power OFF the product and turn the power back ON. The power supply will power on and the product is ready to use. • The figure below shows the sensing edge below the seat cushion and the potential pinch point that should be avoided at all times by both user and loaded patient. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

17. Positioning Chair Users Guide • When moving the Positioning Chair from a seated position to the laying down position (supine), ensure that all body parts are cleared from under the back cushion. The warning label below is affixed to the panel covering the mechanical parts of the product. • Narrow Seat • The Positioning Chair seat cushion is specially designed to keep venous and arterial flow open, ensuring patient assessments are accurate. • 3.0: Specifications • 3.1 Chair Specifications, Dimensions, Capacity, Safety and Power • Class I, Type B Equipment. Not suitable for use with flammable anesthetics, continuous operation and/or ordinary equipment • Only personnel familar with servicing electrical medical devices should service this product. • Grounding Reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “hospital only” or “hospital grade.” Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

18. Positioning Chair Users Guide • The ACS Positioning Chair has the following specifications: • Positioning Chair Weight (approximate) 450 lbs. • Lift Capacity (maximum) 400 lbs.(181.4 kg) • Patient Weight Capacity (maximum) 400 lbs. (181.4 kg) • Loading Height (upright pos. on seat) 27 in. (68.5 cm) • Total Length (upright, sitting) 75 in. (190.5 cm) • Total Length (laying position) 100 in. (254 cm) • Patient Surface Width (seat cushion) 31 in. (78.7 cm) • Patient Surface Width (back cushion) 31 in. (78.7 cm) • Patient Surface Length (minimum) 89 in. (226 cm) • Patient Surface Length (maximum) 98 in. (248.9 cm) • Total Overall Width (with back cushion) 31 in. (78.7 cm) • Power Supply Input Rating: 100-240V, 50-60Hz, 12A-6A • Power Supply Output Rating: 24V, 900W • Power Inlet Circuit Breaker: Thermal type, 10A, 50VDC,250VAC Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

19. Positioning Chair Users Guide • 4-0: Setup/Patient Loading and Unloading • 4-1 Mains Connection and Power • Plug the power line cord into the power inlet receptacle on the back of the Positioning Chair. • The other end should be plugged into a mains power receptacle of 110V, 10A (minimum). The Positioning Chair is powered Only a Medical Grade power cord should be used with the Positioning Chair. Medical Grade power cords are indicated with a green dot near the male plugs. • The Positioning Chair is powered ON by toggling the power inlet switch located on the back of the chair (electrical panel). When chair is powered ON, the power inlet green LED light will illuminate and the power supply fan will start. • 4-2 Patient Loading • Load the patient onto the Positioning Chair seat cushion with the chair position upright. NEVER LOAD OR UNLOAD PATIENT IN THE SUPINE (LYING) POSITION. • After checking to ensure the footrest is securely placed fllush with the ground, the patient may load by either stepping on the footrest to sit, or straddling the main leg of the chair and turning backwards. • The patient’s feet should be spaced evenly on the footrest and should not be positioned at the near or far end of the footrest pad. • Instruct the patient to slide clear back on the seat cushion to avoid falling forward. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

20. Positioning Chair Users Guide • Instruct the patient to ALWAYS PLACE BOTH HANDS SECURELY ON THE HANDRAILS. To avoid pinch points and crushing areas, always have both hands remain on the handrails. • Always provide a verbal notice to the patient before moving the Positioning Chair in either direction. This is especially important when moving the chair from a lying position (supine) to upright as the chair moves quickly (4.5 seconds or less travel) when moving upright. • 4-3 Patient Unloading • When unloading the patient from the Positioning Chair, NEVER LOAD OR UNLOAD PATIENT IN THE SUPINE (LYING) POSITION. • Always ensure that the footrest is securely placed flush with the ground. The footrest is properly grounded when the pad under the footrest is secure and the footrest does not “give” or move when weight is applied to any edge or corner of the footrest cushion. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

21. Positioning Chair Users Guide • 4-4 Parts Overview Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

22. Positioning Chair Users Guide • 5-1: Maintenance/Cleaning/Troubleshooting • 5-1 Preventative Maintenance • Preventative maintenance can be very important in keeping the ACS Positioning Chair in an operational state. • Daily/Monthly Checks • The Positioning Chair is designed to be maintenance-free in the area of adjustments, lubrication and greasing. All mechanical components have been tested to over 10,000 cycles during product development without signs of wear. • On a monthly basis, it is always good to check for bolts, screws and other hardware that may have loosened or “backed out” during use. • No other preventative or routine maintenance is required to keep the ACS Positioning Chair performing as designed. • 5-2 Cleaning and Disinfection • Disinfect the Positioning Chair after each use. Following each examination, the seat and back cushions should be wiped with either a 70% IPA 30% water mixture or Theracide ® Plus cleaner before re-use. Cleaned areas should be allowed to dry for 15 minutes. • In addition, the Permablok3® cushion material on the footrest andseat and back cushions may be cleaned with a1:1 mix of ammonia and water or a 1:4mix of bleachand water if blood,urine or feces are present. Rinse with clean water and dry. • All steel and plastic parts can be wiped with a lint-free cloth. Do not use liquid cleaners on plastic parts. • Always follow cleaning and disinfection instructions as explained in this User Guide for cleaning the Positioning Chair. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

23. Positioning Chair Users Guide • Reduce the risk of Bloodborne Pathogens, always clean and disinfect the chair properly. Failure to clean and disinfect properly may result in injury to patients and/or operators. • Always wear the proper protective clothing when cleaning and disinfecting. Keep the appropriate chemical neutralizer, first aid kit and eyewash bottle nearby in case of splashing. • Do not use corrosive products such as bleach, phenolics, or iodines when cleaning as they may cause premature corrosion to components. • 5-3 Troubleshooting • The following conditions are considered the more common instances of troubleshooting concerns. Please call the Companyif an issue outside of those listed below arises. • Positioning Chair Will Not Move • Possible causes/Solutions: • Chair is unplugged • Solution: plug chair into walls mains outlet • Power inlet (ON/OFF button) is not selected to ON. Green light should be illuminated. • Solution: Select ON mode by pressing toggle switch. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

24. Positioning Chair Users Guide • Power has been interrupted/no fan noise or LED lights illuminated on OFF/ON power button. • Solution: Check circuit breakers and reset. Breaker is found on backside of power box panel, underneath chair by actuator and motor. To locate, remove side panel and look towards back of chair (see picture below). If breaker needs to be re-set, button toggle position will be down. Picture below shows the breaker in an operational position To re-set, toggle switch to up position and select power inlet to ON position. • Foot Control Will Not Move Chair • Possible causes/Solutions: • Chair is unplugged • Solution: Plug chair into wall mains outlet (100V, 10A). • Power inlet (ON/OFF button) is not selected to ON. Green light should be illuminated. • Solution: Select ON mode by pressing toggle switch on back of chair. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

25. Positioning Chair Users Guide • Power has been interrupted/no fan noise or LED lights illuminated on OFF/ON power button. • Solution: Check circuit breaker and reset. Breaker is found on backside of power box panel, underneath chair by actuator and motor. To locate, remove side panel and looks towards back of chair. If breaker needs to be re-set, button toggle position will be down. To re-set, toggle switch to UP position and select power to ON position on back of chair. • Foot control is not plugged into chair or is loose • Solution: Foot control locking connector must be plugged into the chair or adjusted. Remove the side panel to locate connector near the actuator/motor area. • E-STOPs are depressed and need to be re-set • Solution: Re-set ESTOPs by turning clockwise slightly. ESTOP will “pop” out and power supply will start, making chair operational. ESTOPs are located on either side of the Positioning Chair, below the seat cushion as shown: Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

26. Positioning Chair Users Guide • Foot Rest Will Not Re-position • Possible causes/Solutions: • T-handle has not been pulled to release positioning mechanism. • Solution: Pull back the T-handle labeled “Pull to Adjust Foot Rest Position.” While handle is pulled back, push or pull foot rest on its slide to position. Movement of the foot rest may be done in both lying and sit-up chair positions. • TAKE CAUTION when moving the foot rest while the chair is in the lying down (supine) position. When chair is in this position, foot rest is elevated. • TAKE CAUTION when releasing positioning mechanism as foot rest may slide quickly downward when mechanism is released by pulling T-handle. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

27. Positioning Chair Users Guide • Positioning Chair Will Not Power Up When Foot Rest Is Lowered • Possible causes/Solutions: • The ACS Positioning Chair is designed for patient and user safety. One safety function designed into the Chair are limit switches in the knee gatch area. When the foot rest is in the supine position (laying down flat), or in any position other than when the pins are found in the notch area, power to the Chair will be cut-off. • Solution: To re-activate electricity to the Chair, re-position the foot rest pins into the main leg notch area by using the T-handle labeled “Pull To Lay Flat”. • The picture below (left) shows the foot rest in the supine (laying down flat) position. The limit switch magnets are separated, cutting power from the Positioning Chair. As shown in the picture below (right), the foot rest must be raised with pins secured in the notch area for power to be restored to the Positioning Chair. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential

28. Positioning Chair Users Guide • Positioning Chair Movement Seems to “Drift” or Not Stop In Same Position • Possible causes/Solutions: • Limit Switches and/or potentiometer may require adjustment. • Solution:ACS does not recommend adjustment of the limit switches to compensate for drifting or misalignment of chair positions. The Company recommends the user to contact Advanze Cardio Systems and schedule a service call. For reference, the limit switches are found under the left arm rest handle and the potentiometerunder the right arm rest. Version: 001 PHLB5004 Advanze Cardio Systems, Inc.Confidential