DOUBLEFLO Inflow/Outflow Pump Instruction Manual

EN

Instruction manual p.4 - 50

Table of contents EN

Introduction: presentation of the pump

6

General description 1.1 Operator profile 1.2 Target population 1.3 Intended use and contraindications 1.4 Symbols description 1.5 Warnings and general precautions 1.6 Technical characteristics

7 10 10 10 11 15 16

Product description 2.1 System indicators 2.2 Consumable tubing 2.3 Accessories 2.4 Audible indicators 2.5 Light indicators 2.6 Error messages

17 17 19 21 24 24 24

Receiving the equipment 3.1 Transport 3.2 Service life listing

27 27 27

Setup procedures 4.1 Installing the pump 4.2 Connecting the tubing 4.3 Connecting the footswitch 4.4 Communication with the remote control 4.5 Connecting the Hand Control Interfaces (HCI) 4.6 Connecting the Foot Control Interfaces (FCI)

28 28 28 34 34 35 37

Tubing life cycle 5.1 During the operating day: after surgery 5.2 Connection of a new Patient Tube Set for the next operation 5.3 End of operating day

40 40 41 41

Pump functions 6.1 Starting the pump 6.2 Pressure setting adjustment 6.3 LAVAGE mode 6.4 RINSE mode 6.5 Using the equipotential terminal

42 42 42 43 43 43

4

Table of contents EN

Maintaining the device 7.1 Cleaning

44 44

Contact 8.1 Legal manufacturer 8.2 Warranty

45 45 45

Technical characteristics 9.1 Physical dimensions (pump) 9.2 Storage conditions (pump and accessories) 9.3 Operating conditions (pump and accessories) 9.4 Performance specifications (pump) 9.5 EMC compliance matrix

46 46 46 46 46 47

Stock keeping units

50

5

Introduction: presentation of the pump EN

Dear Customer, Thank you for purchasing your arthroscopy pump. This device is delivered with the technical documentation. Please always ensure that this manual is close at hand; it describes your equipment and its operation. This arthroscopy pump must be used with its own tubing. Its system manages irrigation automatically as a function of suction, thereby providing a flow rate and a precisely controlled pressure. Its user-friendly and easy to use Human/Machine Interface (HMI) allows optimum control of the device for the practitioner. The pump is intended for use during arthroscopy operations by orthopaedic surgeons and operating theatre nurses. The pump was developed in collaboration with surgeons in order to meet their expectations and be capable of offering them maximum convenience. The performance of the pump allows: •

conveyance of the irrigation liquid from the bags of physiological saline to the joint via an arthroscopy sleeve, precisely controlling the pressure and flow rates,

•

recovery of the contaminated fluids from the joint via a cannula or a surgical instrument to the waste collection bag,

•

precise control of intra-articular pressure, regardless of the outgoing flow rate,

•

selection of the appropriate suction level (LOW, MED, HIGH),

•

communication with the shaver consoles,

•

integration with the arthroscopic tower.

6

General description EN

The arthroscopy system consists of a pump, accessories and consumables. Accessories:

Consumable tubing:

• • • •

• • • •

Footswitch - Wired Hand Control Interfaces (HCI) Foot Control Interfaces (FCI) Infrared remote control

Day Tube Set Patient Tube Set Inflow Tube Set Outflow Tube Set

Reading this manual is compulsory before any use of the pump, its accessories and its consumable tubing. Inflow Tube Set Outflow Tube Set Arthroscopy sheath / cannula Handpiece Shaver cable Shaver unit (DYONICS POWER II) DYONICS POWER II footswitch S+N Pump / Shaver Interface Cable The Pump J Infrared remote control

A B C D E F G H I

I F

A

B

E

J H D C

G This diagram represents the arthroscopy system with the use of the S+N Pump / Shaver Interface Cable.

7

General description EN

Inflow Tube Set Outflow Tube Set Arthroscopy sheath / cannula Handpiece Hand Control Interface F Shaver unit G Footswitch - Wired H Shaver cable I The pump J Infrared remote control A B C D E

I F

A

B E

H G

D

J C

This diagram represents the arthroscopy system with the use of a hand control interface except for S+N Hand Control Interface.

8

General description EN

Inflow Tube Set Outflow Tube Set Arthroscopy sheath / cannula Handpiece Foot Control Interface Shaver unit Footswitch - Wired Infrared remote control Shaver cable J The Pump

A B C D E F G H I

J

A

F

I B

E D

G C

H

This diagram represents the arthroscopy system with the use of a Foot Control Interface.

9

Precautions for use

1

EN

1.1 Operator profile The DOUBLEFLO system is to be used in the operating theatre; the users include nurses and orthopedic surgeons.

1.2 Target population 8-years-old or older pediatric and adults patients requiring an arthroscopic surgery, regardless of gender.

1.3 Intended use and contraindications Indications The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.

Contraindications The use of the DOUBLEFLO system is prohibited whenever arthroscopy is disallowed.

10

1

Precautions for use

EN

1.4 Symbols description A - Symbol used within this user manual Symbol

Name

Description

Warning

Indicates a hazardous situation which, if not avoided, could result in serious injury or damage. Obey all safety messages that follow this symbol to avoid possible injury or damage.

B- Symbols for pumps and accessories Symbol

Name

Description

Fuse

External fuse rating: T5AH-250V

Manufacturer

Identifies the manufacturer of the medical device

Manufacturing date

Indicates the date on which the medical device was manufactured

Equipotential bonding symbol

Indicates presence of an earth contact on the rear of the pump

Symbol for electrical and electronic equipment waste

This device is subject to separate collection. Return the device to Hemodia at the end of its service life

Refer to the instruction manual

Reading the manual is compulsory before using the pump for the first time

Consult the instruction for use

Indicates to the user that it is necessary to consult the instruction for use

11

1

Precautions for use EN

Symbol

Name

Description

Serial number

Indicates the serial number assigned by the manufacturer in order to formally identify a specific medical device

Manufacturing batch

CE marking

Medical device

Distributor UL marking

Indicates the number of the manufacturing batch Indicates that this equipment complies with the medical device regulations (MDR 2017/745). If applicable, there is also the identification of the notified body (four digits). Indicates that a medical device as defined by the regulations (MDR 2017/745). Indicates the entity that distributes the medical device in the region concerned. Certification mark for components recognized by Underwriters Laboratories in Canada.

RFID technology

Allows communication between the tubing and the pump.

Standby

Identifies the button or button position as well as the activated piece of equipment to put it on standby, and identifies the control to switch to or the state of low power consumption. Each of the power consumption states can be indicated with a corresponding color.

Quantity

Indicates the quantity of product present in the packaging.

Prescription device

Federal law restricts this device to sale by or on the order of practitioner

Catalog reference

Indicates the manufacturer's catalog reference to allow formal identification of the medical device

12

1

Precautions for use

EN

C- Symbol for tubing Symbol

Name

Description

Use-by date

Indicates the date after which the medical device may no longer be used

Do not reuse

Indicates that a medical device may only be used once or on a single patient for one treatment only

Manufacturing date

Indicates the date on which the medical device was manufactured

Sterilized using ethylene oxide

Indicates that the medical device was sterilized with ethylene oxide

Manufacturing batch

Indicates the number of the manufacturing batch

Do not re-sterilize.

This product has not been designed to be re-sterilized

Prescription device

Federal law restricts this device to sale by or on the order of practitioner

Manufacturer

Identifies the manufacturer of the medical device

Warning

Informs the user that the precautions for use need to be consulted for any important information concerning safety, such as warnings and precautions to be taken, which for various reasons cannot appear on the device itself

Protect from humidity

Indicates that the medical device is humidity-sensitive

Catalog reference

13

Indicates the manufacturer's catalog reference to allow formal identification of the medical device

1

Precautions for use EN

Symboll

Name

Description

Unique sterile barrier system with inner protective packaging

Indicates a unique sterile barrier system with a packaging of protection inside.

Do not use if the packaging is damaged and consult the instructions for use

Indicates a medical device which should not be used if the packaging has been damaged or opened and whose user should consult the instructions for use for more information

Quantity

Indicates the quantity of product present in the packaging

14

Precautions for use

1 EN

1.5 Warnings and general precautions The hospital staff are urged to read this manual before using and cleaning this product and its accessories. Failure to abide by these instructions may cause injuries and possible damage to, or malfunction of the equipment. The manufacturer of this device cannot be held liable for direct or consequential injuries or damage resulting from inappropriate use of the single-use products other than the products. Any modification of the device, any repairs performed by an unauthorized service center or any use of single-use products other than the single-use products specified by the manufacturer shall invalidate the manufacturer warranty and the civil liability coverage in case of material damages or bodily harm. The white silicone membranes from the two force sensors on the front panel of the pump have been designed for normal use and all misuses may lead to breakage of the pump which will no longer be covered by the warranty: • Do not use abrasive tools or sharp objects (like knives, scalpels,...) to avoid to tear the white silicone membranes • Do not remove the irrigation tube set with pressure inside to avoid to deform the white silicone membranes The equipment must only be used by personnel trained in arthroscopy procedures. This medical qualified staff must wear standard operating theater protective equipment (mask, gloves, gown, hood). All electro-medical devices have to be located in the non-sterile zone (except for the remote control). Tubing must not be modified. Reprocessing is liable to change the characteristics of the materials, particularly by deformation and degradation, which may have repercussions on the durability of the device and compromise its performances. These risks may potentially jeopardize patients’ safety. Tubing may contain tissues or cells of animal origin or their derivatives, referred to in the EU regulation n°722/2012. The user has to avoid contact with any liquid to the pump and its accessories during the operation. Do not connect the device to an unearthed or poorly earthed source of power. In order to avoid any risk of electric shock, this equipment must only be connected to a power supply equipped with a protective earth. Do not remove the casing (risks of electrocution). In order to avoid any risk of fire, replace spent fuses with fuses of the same characteristics. The system may be affected by electromagnetic interferences generated by other instruments. Check that the other instruments used in the operating theater comply with electromagnetic compatibility (EMC) standard IEC 60601-1-2. The pump is a class 1 device in accordance with electrical safety standard IEC 60601-1, the currently applicable version. The pressure adjustments (chapter 6.2) suggested by the legal manufacturer are based on observations; the values in the table may be modified and should be adapted depending on the operation. Any serious incidents that have occurred in connection with these devices must be notified to the manufacturer and the competent authority of the Member State in which the user is based.

15

Precautions for use

1

EN

1.6 Technical characteristics A - Sterilization The device and the accessories are not sterile. On the other hand, they must be decontaminated after each day of use (see chapter 7.1). The tubing are sterilized by ethylene oxide (EtO). On receiving the tubing, check that the packaging items have not been damaged. If a consignment is opened or damaged, or the expiry date is exceeded, contact the distributor by telephone or email for advise. Never use a product if its sterile packaging is damaged or if the expiry date is exceeded. This symbol applied to a packaging item means that the tubing are for single use in accordance with harmonized practices in the EU (MDR). They cannot therefore be reused. Retreatment is liable to change the characteristics of the materials, particularly by deforming and degrading the latter, which may have repercussions on the durability of the device and compromise its performance. These risks may potentially jeopardize patients' safety.

B - Electrical characteristics • • • •

Input voltage: 100-240 VAC Frequency: 50-60 Hz Current draw: 500 VA External fuse rating: T5AH-250V The pump is not a BF part but it is considered as a BF part for shaver input according to the IEC 60601-1 standard. There is one part considered as BF part: input dedicated for Hand Control Interfaces and Foot Control Interfaces (25 pin connector) situated on the back of the DOUBLEFLO pump.

16

2

Product description

EN

2.1 System indicators A - Front panel of the Pump 7

5

6

1

2 8 9

3

10 4

11 12 15 13

14

1

Irrigation pump head

2

Suction pump head

3

Retaining bracket for the irrigation tubing  Note : The two circles on the right opening are silicone membranes from force sensors. Avoid touching these white silicone membranes

4

Retaining bracket for the suction tubing

5

Pressure decrease

6

Pressure increase

7

 hite LCD screen: Displays the pressure setting and the error messages (colour of the W characters is black)

8

“ START/STOP” button: Starts or stops the fluid management. The indicator flashes when the pump is stopped (upon stop)

9

“ RINSE SUCTION” button: Cannula suction adjustment: Adjusts the flow rate of the cannula (LOW, MED, HIGH). The LED lights up when the flow rate is activated

17

2

Product description EN

10 “SHAVER SUCTION” button: Adjusts the flow rate of the “shaver” (LOW, MED, HIGH). The

LED lights up when the flow rate is activated

11 “LAVAGE” button: Activates the “LAVAGE” mode. The LED lights up when the “LAVAGE”

mode is activated

12 Red “ERROR” LED. The LED lights up when the device detects a problem 13 “POWER” button: Turns the unit on or off. If the pump is enabled, “mmHg” appears on the

display screen.

14 “PEDAL” connector: Allows the wired DOUBLEFLO footswitch to be connected 15 Infrared opening: Allows the communication with the wireless remote control

B - Back panel of the Pump 19 20

18

23

21 22

17 16

16 Main connector 17 Fuse holder and mains plug 18 Equipotential terminal 19 Product reference number (REF) 20 Device serial number (SN) 21 9 pin connector dedicated to LINK DFP 22 25 pin connector dedicated to DOUBLEFLO interface 23 USB connector hidden behind metal sheat to update the software

18

2

Product description

EN

2.2 Consumable tubing Day Tube Set

Towards the Patient Tube Set

From the bags of saline

The Day Tube Set connects the irrigation bags to the Patient Tube Set. The pressure is read through the pressure sensor membranes situated in the blue connector connected on the pump. No contamination is possible among patients if, and only if, the tubing is used in conjunction with a Patient Tube Set. The procedure for installing and changing the tubing is explained in chapters 4.2, 5.1, 5.2 and 5.3. The Day Tube Set is intended for one day use and can be used for several consecutive operations for different patients.

Patient Tube Set The Patient Tube Set is used to convey the sterile saline solution from the Day Tube Set to the arthroscopy sheath / cannula. Towards the arthroscopy sheath / cannula

From the Day Tube Set

The Patient Tube Set is intended for single use and must not be reused.

19

2

Product description EN

Inflow Tube Set The Inflow Tube Set tubing delivers irrigation fluid from the bag to the arthroscopy sheath / cannula. The pressure is read through the pressure sensor membranes situated in the blue connector connected on the pump.

Towards the arthroscopy sheath / cannula

From the bags of saline

The Inflow Tube Set is intended for single use and must not be reused.

Outflow Tube Set The Outflow Tube Set allows suction from the joint, either via a cannula (when the “SHAVER” tube is pinched) or via another suction device, a shaver (when the “OUTFLOW CANNULA” tube is pinched). Both modes are controlled by the “Pinch Valve”. Towards the waste recovery bag

From the surgical site

The Outflow Tube Set is intended for single use and must not be reused.

20

Product description

2 EN

2.3 Accessories Only connect the accessories dedicated for the pump. Please, check the accessories available on chapter 10. Perform functional tests (as mentionned part 3.2) before use on the patient.

A - Footswitch - Wired The wired 4-way footswitch is connected to the Pump (PEDAL connector 14 ). This footswitch allows activation of suction by the “cannula” and “shaver” tubes at the preconfigured levels and activation or deactivation of “LAVAGE” mode.

24 25

26

27

24 This “

• • •

” button makes it possible to: Activate the LAVAGE mode: the user has to momentarily press the button Activate the RINSE mode: the user has to press and keep pressed the button Deactivate the LAVAGE mode: when the LAVAGE mode is activated, the user has to momentarily press again the button (LAVAGE mode deactivated) or press and keep pressed the button (LAVAGE mode deactivated and RINSE mode activated)

There are two operational mode types when the FCI is connected: TYPE 1 - WHEN USING FCI COMPATIBLE WITH ARTHREX SHAVER CONSOLE 25 The “<< <<” control makes it possible to control a shaver in REVERSE mode from a shaver

console and activate suction by the shaver at the preconfigured level. 26 The “<> <>” control makes it possible to control a shaver in OSCILLATION mode from a shaver console and activate suction by the shaver at the preconfigured level. 27 The “>> >>” control makes it possible to control a shaver in FORWARD mode from a shaver console and activate suction by the shaver at the preconfigured level. TYPE 2 - WHEN USING FCI COMPATIBLE WITH CONMED SHAVER CONSOLE <<” control makes it possible to choose the mode on the handpiece (FORWARD, REVERSE The “<< or OSCILLATION). The “>> >>” control makes it possible to activate the pre-selected mode of the handpiece and activate the suction through the SHAVER tube.

21