Amsino iReceptal 3 Operating manual

SL 5107 Rev. D
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iReceptal Digital Surgical Suction System
Site Preparation, Installation, and Maintenance Guide
100～240 VAC Docking Station
REF iRD301
Instructions For Use RxONLY

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Contents
Introduction.........................................................................................................................................3
Conventions..............................................................................................................................3
Contact Information..................................................................................................................3
Indications For Use...........................................................................................................................3
Contraindications For Use................................................................................................................3
Intended patient.................................................................................................................................3
For Use With......................................................................................................................................4
Accessories........................................................................................................................................4
Description..........................................................................................................................................4
User/Patient Safety...........................................................................................................................5
General......................................................................................................................................5
Electrical Safety........................................................................................................................5
Environmental/Biological.........................................................................................................6
Features..............................................................................................................................................7
Symbols..............................................................................................................................................8
Instructions.........................................................................................................................................9
To Install the Docker................................................................................................................9
1. To Install the Docker and Connect Utilities...........................................................10
2. To Apply Power, Water, and Detergent ................................................................11
To Test the Docker.................................................................................................................11
1. To Prepare the Rover...............................................................................................12
2. To Prepare the Docker.............................................................................................12
3. To Perform a Wash Cycle.......................................................................................13
To Shut Down the Docker.....................................................................................................14
Inspection and Cleaning Maintenance.........................................................................................14
Add the Detergent..................................................................................................................15
To Wipe Down the Docker....................................................................................................16
Storage and Handling.....................................................................................................................16
Disposal/Recycle.............................................................................................................................17
Troubleshooting ...............................................................................................................................17
Error Messages ...............................................................................................................................18
Specifications...................................................................................................................................18
Electromagnetic Compatibility.......................................................................................................20

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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.
The iReceptal Digital Surgical Suction System Manifold is non-patient contacting, non-sterile, disposable device
that provide a fluid path from the suction tubing lines of a iReceptal Digital Surgical Suction System to the
receiving collection canisters of this system.
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.
NOTE: A note supplements and/or clarifies procedural information.
Contact Information
For additional information, including safety information, or in-service training, contact your AMSINO sales
representative or call AMSINO iReceptal Customer Service at XXXXXX.
Indications For Use
The iReceptal Digital Surgical Suction System is intended to be used in the operating room, pathology, surgical
centers, and doctor’s offices to collect and dispose of surgical fluid waste as well as collect smoke generated
from electrocautery or laser devices.
Contraindications For Use
The iReceptal Digital Surgical Suction System is contraindicated against:
▪Connection directly to chest tubes.
▪Connection to closed wound drainage systems.
Intended patient
The general patient population is anyone excluding newborn subject to general surgery or diagnostic procedures
where the device can be used.

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For Use With
The following components are required to be used with the equipment described in this manual to create a
complete system:
Description
REF
iReceptal 3 Rover
iRR301 100～120V
iRR302220～240V
iReceptal 3 Docking Detergent
iRC003
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.
The following AMSINO-approved accessories are sold separately:
Description
REF
iReceptal 3 Docking Detergent
iRC003
Power Cord (US)
iRA105-01
Power Cord (UK)
iRA106-01
Power Cord (EU)
iRA107-01
NOTE: For a complete list of accessory information, contact your AMSINO sales representative or call AMSINO
iReceptal Digital Surgical Suction System Customer Service.
Description
The iReceptal Docking Station (docker) is a component of the iReceptal Digital Surgical Suction System. The
Stryker Rover (rover), another component of the system, is a mobile unit used to suction and collect fluid waste
and surgical smoke from a surgical site in an operating room.
After collection, the rover is relocated and mated to the docker. Once the rover is connected to the docker, the
emptying of the fluid waste and cleaning of the canisters occurs automatically (Figure 1).
The rover chambers are rinsed with clean water and iReceptal Docking Detergent REF iRC003 to clean the
chambers of any residual fluid waste (Figure 2).

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Figure 1 To Empty the Canister Figure 2 To Clean the Canister
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.
•Healthcare professionals should be thoroughly familiar with the instructions for use, handling
characteristics, and the indicated and intended uses of this equipment. Contact your AMSINO sales
representative or AMSINO iReceptal Digital Surgical Suction System Customer Service for in-service
training.
•DO NOT disassemble, modify, service, or repair any system component or accessory, unless otherwise
specified. Call AMSINO iReceptal Digital Surgical Suction System Customer Service.
•Upon initial receipt and before each use, inspect each component for damage. DO NOT use any
equipment if damage is apparent or the inspection criteria are not met. See the Inspection and
Maintenance section for inspection criteria.
•ALWAYS operate the equipment within the specified environmental condition values. See the
Specifications section.
•MANUFACTURER will provide circuit diagrams, component part lists, descriptions, calibration instructions
to assist to SERVICE PERSONNEL in parts repair.
•Do not use iReceptal Digital Surgical Suction System in the presence of magnetic resonance imaging
(MRI) devices.
Electrical Safety
•Use only AMSINO-approved system components and accessories, unless otherwise specified. Using other
electronic components and accessories may result in increased electromagnetic emissions or decreased
electromagnetic immunity of the system.
•Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical
equipment like this system. Install and place this system into service according to the EMC information
contained in this manual. See the Specifications section. Portable and mobile radio frequency (RF)
communications equipment can affect the function of this system.
•ELECTRICAL SHOCK HAZARD-ALWAYS connect this equipment to a hospital-grade, facility power
receptacle with protective earth (ground). Failure to comply may cause electrical shock and result in patient

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or healthcare staff injury.
•Please take attention that changes or modification not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
•This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired
operation.
•This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the
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. L'exploitation est autorisée aux deux conditions suivantes :
•(1) l'appareil ne doit pas produire de brouillage, et
•(2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est
susceptible d'en compromettre le fonctionnement.
•This equipment complies with FCC/IC RSS-102 radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with minimum distance 20cm between the
radiator & your body.
•ce matériel est conforme aux limites de dose d'exposition aux rayonnements, FCC / CNR-102 énoncée dans
un autre environnement.cette eqipment devrait être installéet exploitéavec distance minimale de 20 entre
le radiateur et votre corps.
•Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and
maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio
interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically
radiated power (e.i.r.p.) is not more than that necessary for successful communication.
•Conformément àla réglementation d'Industrie Canada, le présent émetteur radio peutfonctionner avec une
antenne d'un type et d'un gain maximal (ou inférieur) approuvépour l'émetteur par Industrie Canada. Dans
le but de réduire les risques de brouillage radioélectrique àl'intention des autres utilisateurs, il faut choisir le
type d'antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse
pas l'intensiténécessaire àl'établissement d'une communication satisfaisante.
Environmental/Biological
•FIRE HAZARD –DO NOT use this equipment in areas in which flammable anesthetics or flammable agents
are mixed with air, oxygen or nitrous oxide. Failure to comply may cause a fire and result in burn injury or
property damage.
•BLOODBORNE PATHOGEN HAZARD
•The Bloodborne Pathogens Standard provided by the United States Occupational Safety and Health
Association (US OSHA 29 CFR 1910.1030) requires those with employees having occupational
exposure to potentially infectious materials to establish a written Exposure Control Plan. The
Exposure Control Plan is designed to eliminate or minimize employee exposure through use of
personal protective equipment (PPE), appropriate vaccinations (e.g. hepatitis B), and other control
measures.

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•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.
•CONTAMINATION HAZARD-ALWAYS follow local regulations for safe handling, recycling, and disposal of
biohazard fluid waste and equipment. See Disposal/Recycle section. Failure to comply may cause
environmental contamination and result in injury.
Features
Figure 3 Docking Station Front view Figure 4 Docking Station Back view
A
Magnet–Provide for the automatic connection of the rover to the docker.
B
Infrared Communication Port –Allow infrared data transfer between the docker and rover. Data
transfer is necessary during the docking procedure.
C
Detergent canister lid –Allows add detergent into the canister
D
Detergent canister- Stores the detergent
E
Fluid Connectors (two) –One connector allows fresh water to enter the rover. The other connector
provides for the disposal of waste water from the rover.
F
Guides (two) –Facilitate the alignment of the rover to the docker.
G
Waste Outlet Port –Allows for the disposal of fluid waste from the rover when the rover is connected
to the docker.
H
Water Inlet Port –Allows fresh water to enter the rover when the rover is connected to the docker.
I
Fixing Casters (four)--Allows adjust the height of each docking station to align with the rover.
Increase caster height by turning the dial counterclockwise. Decrease caster height by turning the
dial clockwise.
J
Power Cord –Allows for the connection of facility electrical power to the docker. Power cord
configurations may vary. See the Accessories section for options.
K
Water Inlet Hose –Allows fresh water to flow from the facility water source to the docker water inlet
port.
L
Waste Outlet Hose –Allows fluid waste to flow from the docker waste outlet port to the drain of the
facility waste disposal system.

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M
Power Cord Receptacle –Allows for the connection of facility power using the docker power cord.
O
Power Switch –Allows for the application or removal of facility power.
N
Specification Label –
Symbols
The following symbols appear on the device and/or its labeling. For more information, see “Technical
specifications”
Symbol
Description
ON (POWER)
OFF (POWER)
ALTERNATING CURRENT (AC)
General warning
Consult instructions for use
Follow instructions for use
This symbol is located near the protective ground locations
on this device
DETERGENTADD PORT
WASTE OUTLET PORT
WATER INLET PORT

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Instructions
To Install the Docker
⚠WARNING：HEAVY EQUIPMENT –ALWAYS have more than one person unpack and move this
equipment from the shipping pallet. See the Specifications section for rover weight. Failure to comply may result
in personal injury.
Figure 5 Docker Lift Points
CAUTIONS:
•Make sure the pressure and temperature values of the facility water supply are within the required specified
ranges. See the Specifications section.
•If mounting the docker to a wall, make sure no gap exists between the docker mounting bracket and the
wall. ALWAYS align the mounting hardware (not supplied) with the wall studs to make sure the docker is
mounted to the wall securely. Failure to comply may cause inadvertent docker movement and result in wall
or product damage.
•ALWAYS use the correct power cord. Configurations may vary. See the Accessories section for power cord
options
NOTES:
•Only individuals trained and experienced in the maintenance of reusable medical devices should install,
inspect, and test this equipment.
•The docker is installed in a utility closet or disposal area with access to electrical power, a water supply,
and a fluid waste drain. The healthcare facility is responsible for the preparation of the installation site and
the availability of utilities. See the Specifications section for electrical power, water, and drainage
requirements. Make sure the installation area meets utility and space requirements.
•If the installation site does not meet local ventilation requirements, obtain and install a ventilation device
that will meet the necessary local requirements.
•The docker is equipped with an internal backflow prevention device. See the Specifications section for
details. Refer to local plumbing codes to determine whether an external backflow prevention device is also

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required.
•Make sure the plumbing configuration is NOT susceptible to water hammer conditions.
•Make sure the waste outlet hose is connected properly to minimize the escape of noxious fumes and
odors.
Figure 6 Minimum Floor Space Requirements
A
Left-Side Clearance
No minimum requirement
B
Right-Side Clearance
15 cm
C
Front Clearance
120cm
1. To Install the Docker and Connect Utilities
a. Place the docker on the floor and against a wall with access to electrical power, water, and a fluid waste
disposal drain.
b. Recommended: Install mounting screws (not supplied) through the mounting bracket of the docker and secure
the docker to the wall.
NOTE: If allowed by current local building and electrical codes, mounting the docker to the wall is strongly
recommended. The docker is not to be installed in a patient environment.
c. Connect the water inlet hose between the water inlet port of the docker and the facility water supply.
d. Connect the waste outlet hose to the waste outlet port of the docker and the drain emptying into the fluid
waste disposal system.