Operator's Manual PCP-0001.2 October 2017
Table of Contents Introduction...4 Intended Use...4 Safety Information...5 Specifications...7 Operating Conditions...7 Lifting and Storing...8 Installation...10 Operation...12 Cleaning...20 Troubleshooting...21 Maintenance...25 Warranty...25 Contact Information...26 2017 P&C Pharma 3
Introduction This manual provides detailed information and procedures to safely operate and maintain the QuartetRx. This manual is intended to introduce and guide the user through the latest factory-approved operation and troubleshooting techniques and practices. Before attempting to operate the QuartetRx, the user must be familiar with all aspects of operation. Read all instructions prior to operating the QuartetRx. THE INFORMATION CONTAINED IN THIS MANUAL IS BASED ON MACHINES MANUFACTURED UP TO THE TIME OF PUBLICATION. P&C PHARMA RESERVES THE RIGHT TO CHANGE ANY OF THIS INFORMATION WITHOUT NOTICE. VISIT WEBSITE, QUARTETRX.COM, FOR THE MOST CURRENT VERSION OF THIS MANUAL. Intended Use The QuartetRx is an automated table-top milling unit designed to compound tablets, drug substances, and capsules into oral liquid formulas. The compounding uses a single specialized plastic container to compound, store, and dispense the formulation. Contact your supplier for appropriate compounding instructions. 4 2017 P&C Pharma
Safety Information We have provided important safety messages in this manual and on the machine. Always read and obey all safety messages. This is the safety alert symbol: This symbol alerts you to hazards that can kill or hurt you and others. All safety messages will be preceded by the safety alert symbol and the words "DANGER", WARNING, or CAUTION. These words mean: IMMEDIATE HAZARDS WHICH WILL RESULT IN SEVERE PERSONAL INJURY OR DEATH. Hazards or unsafe practices which COULD result in severe personal injury or death. Hazards or unsafe practices which COULD result in minor personal injury or product or property damage. 2017 P&C Pharma 5
All safety messages will identify the hazard, tell you how to reduce the chance of injury, and tell you what can happen if the instructions are not followed. To avoid risk of serious injury or death, operation should not be performed by unauthorized personnel. P&C Pharma will not be responsible for any injury or property damage from improper operation. When operating the QuartetRx, the operator assumes responsibility for any personal injury or property damage which may result. The QuartetRx has two important safety labels on the machine: 6 2017 P&C Pharma
Specifications Description Specification Overall width 13.6 in. (34.5 cm) Overall height 13.0 in. (33.0 cm) Overall depth 14.6 in. (37.1 cm) Electrical requirements 100 to 240 VAC, 50 to 60 Hz, 3-wire cord with 3-prong plug provided with machine Maximum amp usage 1.6 amps Sound level 70 dba @ 3 ft (0.9 m) Approximate weight (empty) 26.3 lb (11.9 kg) Operating Conditions Description Operating Condition Location Indoor use only Altitude Up to 6,562 ft (2,000 m) Ambient temperature 41 F to 104 F (5 C to 40 C) Maximum relative humidity 80% RH @ 87.8 F (31 C) to 50% RH @ 104 F (40 C) Supply voltage fluctuation Clearance Up to 24 VAC 4.0 in. (10.1 cm) on all sides 2017 P&C Pharma 7
Lifting and Storing To avoid electrical shock, disconnect the QuartetRx from power source before moving. Failure to do so may result in death, fire, or electrical shock. When moving the QuartetRx, keep hands, feet, and all other body parts away from pinch points. Failure to do so may result in injury. The QuartetRx is equipped with lifting handles so that the machine can be easily moved. The QuartetRx weighs approximately 26.3 lb (11.9 kg) and should only be stored on flat, level surfaces capable of supporting the weight of the machine. NOTE: Do not store the QuartetRx in wet or extremely damp locations. 8 2017 P&C Pharma
LIFTING HANDLES Figure 1 2017 P&C Pharma 9
Installation The QuartetRx should only be installed on a flat, level surface capable of supporting the weight of the machine, while allowing for 4.0 in. (10.1 cm) of clearance on all sides of the machine. The QuartetRx should be placed on the provided foam pad during operation to reduce the sound profile of the machine. Install the power supply cord / disconnect device in the back of the machine before plugging into an outlet. The QuartetRx operates on a standard 100 to 240 VAC, 50 to 60 Hz house current. The wattage rating is printed on the label located near the power supply cord / disconnect device. To avoid electrical shock: Plug power supply cord / disconnect device into a grounded outlet. Do not remove ground prong from power supply cord / disconnect device. Do not use an adapter on the power supply cord / disconnect device. Do not use an extension cord. Failure to follow these instructions may result in death, fire, or electrical shock. Use only provided power supply cord / disconnect device. Failure to follow these instructions may result in death, fire, or electrical shock. NOTE: If the power supply cord / disconnect device is too short, have a qualified electrician install an outlet near the machine. Power supply cord / disconnect device should not be impeded when installed. 10 2017 P&C Pharma
NOTE: Do not install the QuartetRx in wet or extremely damp locations. NOTE: For optimal operation and compounding, install the QuartetRx in an indoor, climate-controlled environment where ambient temperatures are 60 F to 82 F (15.5 C to 28 C). SAFETY LABEL LABEL POWER SUPPLY CORD / DISCONNECT DEVICE POWER SWITCH Figure 2 2017 P&C Pharma 11
Operation If liquid is spilled inside of the machine, stop use and unplug power supply cord / disconnect device immediately. Failure to do so may result in death, fire, or electrical shock. Flammable solvents should never be used in or near the machine. Failure to do so may result in death or fire. Never fill or open compounding and suspension bottles near the machine. Failure to do so may result in death, fire, electrical shock, or damage to the machine. NOTE: Contact your supplier for appropriate compounding instructions. 1. Turn power switch located on rear of machine to on position (Figure 2). 2. Lift machine lid. 3. Remove caps from bottle holders. 4. Remove caps from bottles. 12 2017 P&C Pharma
5. Following the prescribed instructions, place formulation for compounding in amber compounding bottles. BOTTLE CAP MACHINE LID BOTTLE HOLDER CAP COMPOUNDING BOTTLE BOTTLE HOLDER Figure 3 DIGITAL DISPLAY START BUTTON 2017 P&C Pharma 13
It is possible for the foam inserts to become dislodged from machine chuck during a run if no bottle is present. Before inserting a bottle in the bottle holder, ensure all foam inserts are placed securely on machine chucks. 6. Ensure all foam inserts are secure on machine chucks. NOTE: Only perform Step 7 if foam insert is dislodged from machine chuck. 7. Use a pen or pencil to secure foam insert on machine chuck (Figure 4). 14 2017 P&C Pharma
FOAM INSERT MACHINE CHUCK Figure 4 2017 P&C Pharma 15
Ensure caps are securely tightened on all bottles prior to inserting them in machine. Failure to do so may result in damage to the machine. 8. Install caps on compounding bottles securely. 9. Place compounding bottles in bottle holders as needed. Ensure bottles are seated to machine chucks properly by trying to rotate the bottles. The bottles will not rotate once seated properly (Figure 5). If an uneven number of formulations are being compounded, ensure a counterweight bottle of equal weight is placed in the bottle holder opposite of the compounding bottle. If two formulations are being compounded and have a weight difference of more than 0.35 oz (10 g), counterweight bottles of equal weights must be placed opposite the compounding bottles. NOTE: Only perform Steps 10, 11, and 12 if counterweights are needed. 10. Use water to fill clear counterweight bottles. Ensure counterweight bottles are filled to a weight equal to the weight of the compounding bottle opposite the counterweight. 16 2017 P&C Pharma
MACHINE CHUCK Figure 5 2017 P&C Pharma 17
Ensure caps are securely tightened on all bottles prior to inserting them in machine. Failure to do so may result in damage to the machine. 11. Install caps on counterweight bottles securely. 12. Place counterweight bottles in bottle holders as needed. Ensure bottles are seated to machine chucks properly by trying to rotate the bottles. The bottles will not rotate once seated properly (Figure 5). Ensure caps are on bottle holders and secure before starting the QuartetRx. Failure may result in damage to the QuartetRx or harm the operator. 13. Install caps on all bottle holders securely. This process is aided by holding the opposite bottle holder stationary while securing the caps. When operating the QuartetRx, keep hands, feet, and all other body parts away from pinch points. Failure to do so may result in injury. 14. Close machine lid. 18 2017 P&C Pharma
NOTE: The QuartetRx has 2 cycle times, 10 minutes and 12 minutes. The 10-minute cycle should be used when running MaestroRx formulations. The 12-minute cycle is preferable when running formulations that contain liquid diluents. Both cycles may be considered for compounding other formulations. 15. Press and hold start button for 3 seconds to select between the 10 or 12 minute cycle time. The display will flash twice, the machine will beep, and the selected cycle time will remain on the display. 16. Press start button once more to begin cycle. 17. Allow machine to run a complete cycle. NOTE: Machine lid will not open until machine comes to a complete stop. 18. Lift machine lid. 19. Remove caps from bottle holders. This process is aided by holding the opposite bottle holder stationary while removing the caps. 20. Remove compounding and counterweight bottles from bottle holders. Amber compounding bottles are single use only. Reusing compounding bottles could result in grave harm to patients. 2017 P&C Pharma 19
Cleaning If liquid is spilled inside of the machine, stop use and unplug power supply cord / disconnect device immediately. Failure to do so may result in death, fire, or electrical shock. The QuartetRx can be cleaned with a damp cloth and normal household cleaners. Never submerge the QuartetRx. 20 2017 P&C Pharma
Troubleshooting The troubleshooting section of this manual covers basic troubleshooting for error codes and common issues with the QuartetRx. If the following troubleshooting guide does not resolve the problem, contact your supplier for further assistance. If liquid is spilled inside of the machine, stop use immediately. Failure to do so may result in death, fire, or electrical shock. SYMPTOM: Machine Does Not Power On Possible Cause Power supply cord is disconnected from machine Power supply cord is disconnected from power source Master power switch is in the off position Solution Connect power supply cord to machine Connect power supply cord to outlet Turn power switch to the on position 2017 P&C Pharma 21
SYMPTOM: Machine Does Not Operate Possible Cause Power supply cord is disconnected from machine Power supply cord is disconnected from power source Master power switch is in the off position Machine lid is in the open position Solution Connect power supply cord to machine Connect power supply cord to outlet Turn power switch to the on position Close machine lid SYMPTOM: Machine Lid Will Not Open Possible Cause Machine has not come to a complete stop Power lost during cycle Solution Allow time for machine to run a complete cycle Power on machine SYMPTOM: Liquid Spilled Inside Machine If liquid is spilled inside of the machine, stop use and unplug power supply cord immediately. Contact your supplier for further assistance. 22 2017 P&C Pharma
SYMPTOM: Err1 shows on digital display Error Code Description Accelerometer error, excessive vibration Solution 1. Stop operation. 2. Check counterweight bottles to ensure they are filled with a weight equal to the weight of the compounding bottle opposite the counterweight. 3. Using power switch located on rear of machine, turn power off. 4. Turn power on. 5. Resume operation. If error code persists, contact your supplier for further assistance. SYMPTOM: Err2 shows on digital display Error Code Description Not up to speed error, first trip, below 320 rpm Solution 1. Stop operation. 2. Check counterweight bottles to ensure they are filled with a weight equal to the weight of the compounding bottle opposite the counterweight. 3. Ensure bottle holder caps are tightened securely. 4. Using power switch located on rear of machine, turn power off. 5. Turn power on. 6. Resume operation. If error code persists, contact your supplier for further assistance. 2017 P&C Pharma 23
SYMPTOM: Err3 shows on digital display Error Code Description Not up to speed error, second trip, below 380 rpm Solution 1. Stop operation. 2. Check counterweight bottles to ensure they are filled with a weight equal to the weight of the compounding bottle opposite the counterweight. 3. Ensure bottle holder caps are tightened securely. 4. Using power switch located on rear of machine, turn power off. 5. Turn power on. 6. Resume operation. If error code persists, contact your supplier for further assistance. SYMPTOM: Err4 shows on digital display Error Code Description Speed dropped below 370 rpm during operation Solution 1. Stop operation. 2. Ensure bottle holder caps are tightened securely. 3. Using power switch located on rear of machine, turn power off. 4. Turn power on. 5. Resume operation. If error code persists, contact your supplier for further assistance. 24 2017 P&C Pharma
Maintenance There are no user serviceable parts in the QuartetRx. Contact P&C Pharma if machine needs serviced. Warranty P&C Pharma provides a one year limited warranty for QuartetRx. P&C Pharma, at their discretion, will repair or replace products found to have manufacturing defects within this time period. P&C PHARMA DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO THE PRODUCTS, INCLUDING, WITHOUT LIMITATION, ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. WITHOUT PREJUDICE TO THE GENERALITY OF THE FOREGOING, COMPANY SPECIFICALLY DISCLAIMS AND HEREBY WAIVES ANY LIABILITY WITH RESPECT TO ANY PRODUCT WHICH: (a) HAS BEEN TAMPERED WITH, OR IN ANY WAY ALTERED OR MODIFIED, OTHER THAN BY COMPANY; (b) HAS BEEN SUBJECT TO MISUSE, NEGLIGENCE, OR ACCIDENT OTHER THAN BY COMPANY; OR (c) HAS BEEN STORED, HANDLED, MAINTAINED, OR USED IN A MANNER CONTRARY TO COMPANY S INSTRUCTIONS, THE PRODUCTS LABELING OR COMMON INDUSTRY PRACTICE The QuartetRx must be registered within 20 days of purchase at http://quartetrx.com/warranty in order to activate the warranty. 2017 P&C Pharma 25
Contact Information Address: 955 Congress Park Drive - Dayton, OH 45459 Phone: 937-813-7800 Email: info@pandcpharma.com 26 2017 P&C Pharma
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