iReceptal Digital Surgical Suction System Installation, Operation and Maintenance Guide 100～120 VAC Rover REF iRR301-01 220～240 VAC Rover REF iRR302-01 Instructions For Use 1 Rx ONLY SL5019 Rev.
�WARNING: HIGH SUCTION DEVICE Only trained and experienced healthcare professionals may use this equipment. DO NOT connect directly to chest tubes. DO NOT connect to closed wound drains. DO NOT connect directly to tracheal tubes. ALWAYS use the minimum suction setting required to achieve the desired clinical outcome. NOT FOR USE as a suction source for organ stabilizer/ positioner or patient positioner devices. NOT FOR USE as a suction source for intermittent suction applications.
Contents Introduction .......................................................................................................................................... 5 Conventions................................................................................................................................. 5 Contact Information .................................................................................................................... 5 Indications For Use ...............................................
6. To Test the 4.5-liter Chamber light ................................................................. 31 7. To Test the UV light .......................................................................................... 31 To Adjust the Rover Settings .......................................................................................... 32 Before the Procedure ............................................................................................................... 32 To Setup the Rover ........
Introduction This Instructions For Use manual is the most comprehensive source of information for your product. Keep and consult this reference manual during the life of the product. Conventions The following conventions are used in this manual: WARNING: A warning highlights a safety-related issue. ALWAYS comply with this information to prevent patient or healthcare staff injury. CAUTION: A caution highlights a product reliability issue. ALWAYS comply with this information to prevent product damage.
Fluid suction tubing NOTE: Smoke Evacuator tubing and other accessories are also required for a complete system. These components may not be sold by AMSINO. See the Contact Information section for more information. Accessories This section describes system components that may be ordered to replace original equipment that is damaged, worn, or must be replaced. This section may also contain optional components used with the system.
Figure 1 To collect Fluid Waste Figure 2 To Evacuate Surgical smoke Surgical smoke may also be evacuated from the surgical site through smoke tubing connected to the smoke evacuator filter installed in the rover. The surgical smoke is filtered inside the rover (Figure 2). After collection, the rover is relocated and mated to the iReceptal Digital Surgical Suction System Docking Station (docker).
User/Patient Safety � WARNINGS： General • Before using any system component, or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the system components prior to use. • Only trained and experienced healthcare professionals may use this equipment.
Low Suction • LOW SUCTION HAZARD NOT FOR USE as a suction source for the following applications: • Organ stabilizer/positioner devices • Patient positioner devices Death or serious injury can result from fluctuating suction levels. High Suction • HIGH SUCTION DEVICE [MAX = 528 mmHg/70kPa] • The effectiveness of aspiration is dependent upon the intensity of the vacuum applied. • ALWAYS use the minimum suction setting required to achieve the desired clinical outcome.
following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. • Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radioexempts de licence.
• ALWAYS wear PPE when operating or handling this equipment. • ALWAYS follow local regulations regarding proper handling and disposal of biohazard waste. Failure to comply may cause infection and result in healthcare staff injury. • ALWAYS clean the equipment as indicated upon initial receipt and before each use. DO NOT place the rover within the sterile field. Failure to comply may cause infection and result in patient or healthcare staff injury.
Features Figure 5 A Rover Front View Figure 6 Rover Back View 22L (22-liter) Lower Chamber of Canister – Allows for the containment of liquids. The 22-liter Lower Chamber receives fluid through the upper chamber during the collection of fluid waste. The Lower Chamber contains a fluid level sensor to provide input to the LCD display. B 4.5L (4.5-liter) upper chamber of Canister – Allows for the collection and containment of liquids. The 4.
prevents foreign objects from entering the canister. F Powered IV Pole – This motor-powered IV pole is capable of holding four three-liter [3000 mL] IV bags, one bag per hook. G LCD Display – Provides the operation of rover. Provides visual display of the fluid volume values of each chamber. Display brightness may also be adjusted. See the To Adjust the Rover Settings section. Provides suction values for the canister, system status and error messages.
Physical Buttons A Suction Off/Stop Docking Button– Push the button to stop fluid suction or stop docking. B Pop the manifold out Button – Push the button to pop the manifold out. Graphical user interface iReceptal Digital Surgical Suction System Rover display is a touch screen, where you slide (1) or tap (2) the icons and soft keys gently with your fingertip to select them. • 1．Tapping soft key • 2．Sliding soft key Touch screen colors When a screen item is interactive, it is displayed in green.
with available functions appear green. Disabled items or inactive items appear grey. When you tap a screen item, the item is filled with green to give feedback on successful action. System On The system will present a “welcome screen” automatically after connected to the facility power with the switch turned “ON”. High suction device warning view Without any operation, the “high suction device warning view’’ will pop up.
Manifold installation view Please follow the requirements to install the manifold. For help information about installation, see the "Help View" section. Install a new disposable manifold into the manifold socket. Make sure the manifold is fully inserted and locked into place. See the instructions for use supplied with the manifold for more information The Manifold installation view is divided into three functional sections: 1.
Main view The main view is divided into five functional sections: 1. The left section (1) contains four soft keys for switching the view of the interface: Main, Settings, Data, and Help. 2. The middle sections (2) (3) allow start the pump and the adjustment of the suction setting level, also, right the suction regulator shows a graphical presentation of the upper chamber and Lower Chamber of the canister status and collected fluid. 3.
Middle section Notification Message area – The area displays Notifications//Warnings. The area flashes "High vacuum in operation" as the negative Suction Setting value is in the high negative pressure range. when the canister is full, this area flashes "Canister full, Dock the Rover". Suction Level Value Area – Provides the suction level value for the canister. The actual negative pressure value is displayed in the middle, indicating the current suction level actually present in the canister.
Right section Smoke Filter Indicator – Displays the smoke filter’s remaining usable time as a percentage. Note: When the maximum filter is consumed, “Smoke Filter about to its useful life" voice message will be heard with Message area flashes the relative notification. Smoke Evacuator Power Setting bar – Tap any position on the Setting bar or slide the point to adjust the Smoke evacuator power.
System Setting Options Menu Settings Function Default Date YYYY-MM-DD Tap the year box. The selected box is highlighted. Adjust the year with the arrow keys. The arrow keys only affect the selected box. 2020-01-01 Time hh : mm Tap the hours box. The selected box is highlighted. Adjust the hours with the arrow keys. The arrow keys only affect the selected box. 00：00 Suction unit kPa, mmHg Tap the key to select the suction unit shown on the screen.
another one for docking operations, change the view by tapping the Data key. The following data is saved for every fluid suction operation: Time Date Hospital Rover ID Manifold ID Patient ID Vacuum name Fluid Filter ID Volume Filter Exp.
The Help view is divided into two sections: 1. The left section is the operation instructions, including: Manifold, Rover Operation, and Docking Drain and Clean. 2. The right section is the Troubleshooting, including: Manifold Troubles, Rover Troubles, and Docker Troubles. Operation Instructions Manifold Operation instruction key-Tap the key opens the Manifold related operation instructions. For more information, see “Operation Instructions table”.
2. Make sure the manifold door is open 3. Insert the Manifold 4. Make sure the Manifold is inserted completely in place 1. Eject Manifold Manifold To take out the manifold, please hold the uninstallation manifold with one hand and push the “Eject Manifold” button with the other hand. Rover Smoke operation installation filter 1. Please use new ULPA Filter with Encrypted RFID chips instruction 2. Insert the ULPA Filter 3.
The Wash Cycle View is divided into four functional sections: 1. The left section presents the internal connections of the system. 2. The middle section is the three Wash Cycle keys, for the wash cycle options, please refer to the “Wash Cycle Options Table”. 3. The right section shows the shows a graphical presentation of the detergent volume and the pressure of the fresh water. 4.
socket. No Smoke Filter is detected. please install a smoke filter. No Smoke Filter detected. Replace smoke filter. The smoke filter will expire in XX minutes. It can work about another XX minutes. please replace the filter timely. Smoke filter shortly. Replace smoke filter. Smoke filter expired. Please replace with a new one. Smoke filter expired. Replace smoke filter. Please attempt to dock again. Docker communication error Dock rover again.
Lower chamber full Lower chamber full Dock Docking in place Smoke evacuator filter Smoke evacuator filter about to its useful life Symbols The following symbols appear on the device and/or its labeling.
Do not connect directly to tracheal tubes Do not connect to closed wound drains This symbol signifies that the device is in conformity to the specifications of the Council Directive 93/42/EEC for medical products. Manufacturer. Date of manufacture. Catalog number Serial number Marking of electric and electronic equipment in accordance with Directive 2002/96/EC indicating separate collection for WEEE-Waste of electrical and electronic equipment when disposed.
Humidity limitation: 10% ~95% Atmospheric pressure limitation: 500 hPa ~ 1060 hPa Operating conditions Temperature limit: 10℃ ~+60 ℃ Humidity limitation: 10% ~95% Atmospheric pressure limitation: 700 hPa ~ 1060 hPa Symbols used in graphical user interface are explained in section System Overview. Instructions Before First Use To Unpack the Rover ⚠ WARNING: HEAVY EQUIPMENT - ALWAYS have more than one person unpack and move this equipment from the shipping pallet.
Figure 7 High Suction Device Warning 2. To Test Fluid Suction a. After control the user interface, following the instructions of Patient information input view to input the patient information by scanning the patient’s barcode with the scanner supplied with the rover or input the patient information directly or skip it by tapping the “skip” key below. See the Patient information input view section for more information. b.
a. Tap the "Smoke Evacuator" key (Figure 9) or Depressing and releasing the footswitch (if connected). Figure 9 To Test Smoke Evacuation b. Figure 10 To Adjust Smoke Evacuation Tap the "Smoke Evacuator Power Setting" key to input or use the " Smoke Evacuator Power Setting" bar to adjust the smoke evacuator power. Make sure the smoke evacuation functions correctly. If not, see the Troubleshooting section. NOTE: See the “To Adjust the Rover Settings” section to make setting changes as required. 4.
Figure 12 To Test Upper and Lower Chamber access door 6. To Test the 4.5-liter Chamber light Tap the Chamber light key that control the Upper Chamber light (Figure 13). Make sure the 4.5-liter Chamber light functions correctly. If not, see the Troubleshooting section. Figure 13 To Test 4.5-liter Chamber light 7. To Test the UV light Tap the UV light key that control the UV light (Figure 14). Make sure the UV light functions correctly. If not, see the Troubleshooting section. 31 SL5019 Rev.
Figure 14 To Test UV light To Adjust the Rover Settings 1. Make sure the power cord is connected between the rover and facility power. 2. Make sure the power switch is in the ON position and the HIGH SUCTION DEVICE WARNING has been acknowledged. Make sure the manifold is installed correctly. 3. From the user interface, tap the Settings key to open the system setup view (Figure15). 4. From the system settings view, tap as needed to select the system settings you want to adjust. 5.
Maintenance section for inspection criteria. DO NOT use the rover until it has been tested properly to ensure functionality. See the To Test the Rover section. • ALWAYS clean the equipment as indicated upon initial receipt and before each use. DO NOT place the rover within the sterile field. Failure to comply may cause infection and result in patient or healthcare staff injury. CAUTION: DO NOT clamp or attach any accessory onto the pole or base of the powered IV pole assembly.
NOTE: The fluid suction tubing and suction accessory are applied parts. a. After control the user interface, following the instructions of Patient information input view to input the patient information by scanning the patient’s barcode with the scanner supplied with the rover or input the patient information directly or skip it by tapping the “skip” key below. See the Patient information input view section for more information. b.
Figure 18 To Prepare for Smoke Evacuation 4. To Use the IV Pole a. Hang one irrigation bag on each IV pole hook, if required. The maximum volume allowed per hook is 3000 milliliters (Figure 19). b. Tap and hold the IV pole UP arrow key to raise the IV pole to the desired height. c. See the To Operate the Rover section. Figure 19 To Use the IV Pole 5. To Use the 4.5-liter Chamber light a． Tap the Chamber light key to turn on the 4.
Figure 20 To Use 4.5-liter Chamber light During the Procedure To Operate the Rover � WARNINGS： • HIGH SUCTION DEVICE [MAX = 528 mmHg/ 70kPa] • The effectiveness of aspiration is dependent upon the intensity of the vacuum applied. • ALWAYS use the minimum suction setting required to achieve the desired clinical outcome. • ALWAYS follow your institution’s guidelines for suction limits. • DO NOT connect directly to chest tubes. • DO NOT connect to closed wound drains.
NOTES: • This equipment provides an adjustable suction limit of 37 to 528 mmHg/5 to 70kPa measured with all ports closed. • Make sure the rover has been prepared for collection properly. See the To Setup the Rover section. 1. To Control Fluid Suction NOTE: See the High Suction Indicator table for important condition, indication and action information. a.
Figure 23 To Control Smoke Evacuation 3. Figure 24 To Adjust Smoke Evacuation To Adjust the IV Pole Tap and hold the IV pole UP or DOWN arrow keys to raise or lower the pole height, respectively (Figure 25). Figure 25 To Adjust IV Pole 4. To Open or Close the Chamber access doors Tap the Upper or Lower Chamber access door keys to open/close the Upper and Lower Chamber access door (Figure 26). Figure 26 To open or close Upper and Lower Chamber access door 5. To Open or Close the 4.
Figure 27 To turn on or turn off the 4.5-liter Chamber light 6. To Manage Full Canister NOTE: See the Fluid Volume Indicators table for conditions, indications and actions related to a full or almost full canister. a. If the 4.5-liter chamber is full, the contents in the 4.5-liter chamber would flows into the 22-liter chamber automatically. Tap the EMPTY 4.5L CANISTER key on the user interface anytime if you want to empty the 4.5-liter chamber (Figure 28). b.
Lower Chamber is full – The fluid volume level is near full capacity. Fluid suction will soon stop in the full canister. One “Lower chamber full” voice; the Lower Chamber area flashes “Lower Chamber full” Prepare to relocate and dock the rover to dispose of waste. Canister full – The fluid volume level is at full capacity. Fluid suction has stopped in the full canister.
Figure 30 To Shutdown Suction d. Push the pop the manifold out Button until the manifold is unlocked, then pull the manifold and attached suction tubing out of the receptacle, always keeping the manifold in a horizontal orientation (Figure 31). Figure 31 To Release Manifold e. Figure 32 To Remove Manifold and Tubing Properly dispose of the used manifold and attached suction tubing always maintaining the manifold in a horizontal orientation (Figure 32). f.
3. To Remove IV Pole Components a． Tap the IV POLE DOWN key to lower the IV pole. b． Remove any irrigation bags on the IV pole as required. Figure 34 To Remove IV Pole Components 4. To Remove Power a． Turn off the 4.5-liter chamber light by tapping the 4.5-liter light key on the user interface, if required. b． Close the chamber access doors by tapping the chamber access door keys on the user interface, if required. c． Push the power switch to the OFF position.
Figure 36 Transport Configuration 6. a. To Relocate the Rover If both chambers are full or the rover contains fluid waste and will not be used within two hours, relocate the rover to the docker. See the To Dock the Rover section. b. If the chambers are not full and the rover will be used within two hours, relocate the rover to the desired location. See the To Setup the Rover section.
• The docker provides power to the rover during the docking process. • After docking the rover, DO NOT lock the rover casters. 1. To Prepare the Docker a. Make sure the power switch is in the ON position and illuminated. b. Make sure the bottle of Detergent has enough detergent to perform a wash cycle. Figure 37 To Prepare the Docker 2. To Perform a Wash Cycle a． Push the rover toward the docker and between the guides until the rover and docker attach automatically (Figure 38). b.
• During the first rover docking procedure, the information on the user interface display may appear inconsistent. The procedure may also take a few more minutes than specified in the Wash Cycle Options table. Both conditions are normal and temporary. • If a specific wash cycle is not selected within ten seconds, the “Wash” cycle will be performed automatically. See the Wash Cycle Options table.
equipment if damage is apparent or the inspection criteria are not met. • DO NOT disassemble, modify, service, or repair any system component or accessory, unless otherwise specified. Call AMSINO iReceptal Customer Service. NOTES: • Only individuals trained and experienced in the maintenance of reusable medical devices should install, inspect, and test this equipment. • For service, contact your AMSINO sales representative or call AMSINO iReceptal Customer Service.
Cleaning � WARNING：ALWAYS clean the equipment as indicated upon initial receipt and before each use. Failure to comply may cause infection and result in patient or healthcare staff injury. CAUTIONS: • DO NOT immerse any system component in liquid. DO NOT allow liquids or moisture to enter any electrical connection. • DO NOT sterilize any system component. • DO NOT use solvents, lubricants, or other chemicals, including glutaraldehyde or similar chemical cleaners, unless otherwise specified.
Figure 40 To wipe down the rover 3. Using a clean cloth moistened with disinfectant, wipe all surfaces. Make sure all surfaces remain visibly wet at room temperature for at least the minimum time specified in the instructions supplied by the disinfectant manufacturer. 4. Remove any excess disinfectant solution using a soft, lint-free cloth moistened with water if required by the instructions supplied by the disinfectant manufacturer. 5. Inspect the rover. See the Inspection and Maintenance section.
• Call AMSINO iReceptal 3 Customer Service for rover decontamination procedures. • Discarded electromedical equipment must not be disposed together with waste but must be collected separately to guarantee ecologically correct disposal to prevent dispersion of potential pollutants into the environment. Please hand in the device at the end of its useful life to the local collection and recycling point for electrical and electronic devices.
instructions for use supplied with the manifold. The SUCTION SETTING Adjust the SUCTION SETTING . are too low. The vacuum pump or internal Remove the rover from use. Contact sensor is damaged. AMSINO iReceptal Customer Service. The rover’s suction capability is The vacuum pump is damaged. lost. Remove the rover from use. Contact AMSINO iReceptal Customer Service. A filter error appears on the user The smoke evacuator filter has Replace the smoke evacuator filter. interface display.
Customer Service if the clog persists. An error occurs during EMPTY More than four EMPTY 4.5L 4.5L CHAMBER procedures have been CHAMBER procedure. attempted. The contents of the 4.5-liter Dock the rover. Dock the rover. chamber cannot fit into the 25-liter chamber. Sporadic electrical interference Electrical noise is present. is experienced. Turn off all the electrical equipment not in use in the room. Relocate the electrical equipment to maximize the distance between the equipment.
docked and the rover cannot be removal of the rover from the the docker. Wait 10 seconds. removed from the docker. docker. Pull the rover away from the docker. Wait 60 seconds. Dock the rover. The rover cannot be removed If the problem persists, the fluid Contact connectors may be damaged. Customer Service. The four casters are locked. Make sure the four casters are from docker. AMSINO iReceptal unlocked. The casters do not need to be locked when the rover is docked.
Specifications TABLE 1. Rover specifications REF iRR301-01 iRR302-01 Electrical Power Requirements: 100-120V~, 50/60 Hz, 8 A, single 220-240V~, 50/60 Hz, 4.
Pollution Degree 2 Environmental Conditions: Operation： Temperature Limitation：10℃ ~ 40 ℃ Humidity Limitation： 30% ~ 75% Atmospheric Pressure Limitation:：70kPa ~ 106kPa Storage and Transportation (before initial use)： Temperature Limitation：-20℃ ~ 40 ℃ Humidity Limitation： 10% ~ 75% Atmospheric Pressure Limitation：50kPa ~ 106kPa Storage and Transportation (after initial use)： Temperature Limitation：10℃ ~ 40 ℃ Humidity Limitation： 10% ~ 75% Atmospheric Pressure Limitation：50kPa ~ 106kPa Installation
Smoke evacuation Maximum Smoke Evacuator Flow Standard Hose I.D. Flow Rates Setting 22mm (7/8’’). 707LPM (25CFM) 9.5mm (3/8’’). 130LPM (4.6CFM) 6.4mm (1/4’’). 60LPM (2.1CFM) NOTE: The specified flow rates were obtained using smoke tubing with a 1.8m length. Actual flow rates may vary depending on the length and diameter of the smoke tubing used. Smoke evacuation tube connection 6.4mm, 9.5mm, 22mm RFID Operating frequency range 13.
Electromagnetic Compatibility Guidance and manufacturer's declaration - electromagnetic emissions The iReceptal 3 Rovers, REF iRR301-01 iRR302-01, is intended for use in the electromagnetic environment specified below. The customer or the user of the iReceptal 3 Rovers, REF iRR301-01 iRR302-01 and, should assure that it is used in such an environment.
variations on power 40% UT 40% UT Rovers, REF iRR301-01 iRR302-01, supply input lines (60% dip in UT) (60% dip in UT) requires continued operation during power IEC 61000-4-11 for 5 cycles for 5 cycles mains interruptions, it is recommended that 70% UT 70% UT the IReceptal 3 Rovers, iRR301-01 (30% dip in UT) (30% dip in UT) iRR302-01, be powered from an for 25 cycles for 25 cycles uninterruptible power supply or a battery.
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 IReceptal 3 Rovers, iRR301-01 iRR302-01, are used exceeds the applicable RF compliance level above, the IReceptal 3 Rovers, iRR301-01 iRR302-01, should be observed to verify normal operation.
Appendix To Use Auxiliary Suction Ports (optional) The auxiliary suction ports allow connection to a hospital wall suction regulator if an alternate suction source is required. � WARNINGS： • The rover CAN regulate hospital wall suction. ALWAYS use a hospital wall suction regulator to first control suction level and use the rover to second control and monitor suction level when using the auxiliary suction ports. Failure to comply could result in serious injury or death.
Figure 42 High Suction Device Warning 3. Install a new disposable manifold into the manifold socket. Make sure the manifold is fully inserted and locked into place. 4. Attach suction tubing between the hospital wall suction regulator and the auxiliary suction ports on the rover (Figure 43). 5. Apply and regulate the suction level provided to the rover from the hospital wall suction regulator. 6.
