Medela Dominant Flex Surgical Suction Pump - Instructions for Use

Introduction

The Medela Dominant Flex is a high-quality surgical suction pump designed for various medical suctioning needs. It offers three selectable flow rates for flexibility and combines ease of handling with safety features for optimal operation. The pump is intended for creating a constant vacuum in hospitals and clinics for aspirating surgical fluids, tissue, gases, bodily fluids, or infectious materials.

Warnings and Safety Instructions

WARNINGS indicate potentially hazardous situations that could result in death or serious injury if not avoided.

CAUTIONS indicate potentially hazardous situations that could result in minor or moderate injury if not avoided.

SAFETY RELATED TIP provides useful information about the safe use of the device.

General Safety Precautions:

• For use only by medically trained personnel adequately trained in suction procedures and aspirator use.
• Ensure the equipment is connected to a power socket with protective ground to avoid electric shock.
• Do not use for suctioning explosive, flammable, or corrosive liquids.
• Connecting tubing must not directly contact the suction area; always use a sterile suction catheter.
• Disconnect the power plug before cleaning.
• No modifications to the equipment are allowed.
• Consult indications for use, risk factors, and contraindications before use. Failure to follow instructions may result in serious or fatal injury.
• Not suitable for low vacuum needs (e.g., thoracic drainage) without specialized accessories. Not approved for outdoor or transport applications.
• Do not connect to a passive drainage tube.
• Avoid using anti-static tubing with endoscopes to maintain patient safety.
• When used for aesthetic body contouring, be aware of potential risks like weight reduction limitations, caution with chronic conditions, and fluid loss impact.
• The pump may shut down due to electrostatic discharge (ESD) events.
• Keep wireless communication equipment at least 1 ft (30 cm) away to prevent interference.
• Ensure adequate ventilation for rack versions (5 cm clearance).
• Monitor the patient and the device status regularly. Report any signs of infection or complications immediately.
• The Dominant Flex is MR Unsafe; do not take it into an MR environment.
• Contact Medela Customer Service for repairs if the power cord, plug, device, or its safety features are damaged or malfunctioning.
• Keep the power cord away from hot surfaces.
• Ensure the mains plug does not contact moisture.
• Never pull the plug by the cord.
• Do not leave the device unattended when switched on.
• The pump must stand upright during use.
• Avoid use in high room temperatures, when tired, or in explosive environments.
• Never place the device in water or other liquids.
• Single-use products are not intended for reprocessing; reuse can cause cross-contamination.
• Use Medela suctioning equipment only for removal of bodily fluids, not administration.

Product Overview

Description

The Dominant Flex is a high-quality suction pump powered by a piston/cylinder system, providing maximum suction performance. It features three selectable flow rates (40, 50, or 60 l/min) for surgeon preference and combines easy handling and reprocessing with safety features. A comprehensive range of Medela accessories can be used to configure the pump for various medical applications.

Intended Use/Indications

The Dominant Flex suction pump is intended for creating a constant vacuum (0 to -95 kPa) for use in hospitals and clinics. It is indicated for general surgery, liposuction, endoscopy, epicardial ablation, nasopharyngeal suction, neurosurgery, OPCAB, vacuum-assisted cesarean/delivery, and wound drainage.

Intended User

The Dominant Flex should only be operated by properly trained healthcare professionals with adequate hearing and visual faculties. Training should be refreshed annually.

Intended Patient Population

The Dominant Flex is intended for use on patients exhibiting conditions described in the indications for use.

Contraindications

Specific contraindications apply for epicardial ablation (do not apply suction over an artery or aneurysmal tissue) and off-pump coronary artery bypass (do not position stabilizers over coronary arteries, infarcted/aneurysmal tissue, or fragile tissue). For aesthetic body contouring, contraindications include current infection, bleeding history, emboli, thrombophlebitis, edema, certain medications, poor skin elasticity, diabetes, poor circulation, severe lung/heart disease, collagen disorders, and pregnancy.

Complications (Aesthetic Body Contouring)

Potential complications include infections, embolism, visceral perforations, seroma, nerve compression, swelling, skin necrosis, fluid imbalance, hematomas, scarring, discoloration, fainting, and tissue damage.

Important Note

Physicians are responsible for proper surgical procedures and techniques and must evaluate treatment appropriateness based on their knowledge and experience.

Installation and Setup

Initial Delivery Check

Verify the delivery package for completeness and condition. The package typically includes the Dominant Flex pump (portable or rack version), power cord, Allen key, reusable jar (0.25l), and silicone tubing.

Main Elements of the Suction Pump

Key components include:

• Vacuum Gauge
• Vacuum Regulator
• On/Off Button
• Safety Set (includes mechanical overflow protection, tubing port, lid with clamps)
• Flow Change Buttons
• Standard Rail (for rack version)
• Mobile Trolley (optional accessory)
• Foot on/off switch (trolley)
• All castors with brakes (trolley)
• Back of device: Cable holder, Port for optional foot on/off switch, Fuses, Appliance inlet, Equipotential conductor.

Assembly Steps (General)

The document outlines several assembly and setup procedures, often illustrated with diagrams:

• Removing Transport Lock: Remove a red note and screws.
• Setting up Mobile Version: Assembling the trolley, positioning the pump on the trolley, and attaching the cable holder.
• Setting up the Safety Set: Attaching mechanical overflow protection to the lid, attaching the lid to the jar, and closing lid clamps. Attaching the Safety Set to the pump.
• Assembly of Basic Configuration: Ensuring the Safety Set is attached, optionally attaching a filter, and connecting necessary accessories.
• Assembly of Optional Foot Switch: Connecting the foot switch plug and testing its function.
• Assembly of Collection Systems: Refer to specific instructions for Medela Disposable/Reusable Collection Systems and filters.

Vacuum Assisted Delivery (VAD) Setup

This section details connecting a foot vacuum regulator, attaching tubing from a suction cup to the collection system (liner or jar), switching on the pump, setting maximum vacuum, and verifying it against specifications. The process involves using the foot regulator to control vacuum levels.

Preparation for Use

Checks Before Use

• Inspect the pump for damage to the power cord/plug, obvious device damage, or safety defects.
• Check the completeness and condition of the delivery package.
• Inspect all accessories: suction jars, lids, and liners for cracks or damage; tubing for cracks and secure connectors.
• Perform an additional safety test by evacuating the system to maximum vacuum before actual use.

Connecting to Power

Connect the power cord to the appliance inlet at the back of the pump, secure it with the mounting bracket, and plug into a mains socket. An internal self-test is performed, indicated by a green LED.

Verifying Maximum Vacuum

Switch on the pump, set the vacuum regulator to maximum, clamp the patient tubing, and check the vacuum gauge against specifications. If vacuum is not reached, refer to troubleshooting.

Operating Instructions

Changing Flow Rate

After switching on, the pump defaults to 50 l/min. Touch the flow change buttons to select 60 l/min (turbo), 50 l/min (nominal), or 40 l/min (whisper) modes.

Changing Vacuum Level

Clamp the patient tubing. Turn the vacuum regulator clockwise to increase vacuum or counter-clockwise to decrease it, checking the vacuum gauge for the desired setting.

Placing Out of Operation After Use

Touch the on/off button to switch off the pump. Disconnect the mains plug. Clean and disinfect the device as per the "General Reprocessing Guidelines".

Troubleshooting

No LED Lit

Check power connection or fuse replacement.

Yellow LED Indicator Lit

Minor case (pump on/off): Contact technical department/service center.

Major case (pump not on/off): Contact technical department/service center for repairs.

Motor Not Running

Verify the pump is switched on (standby LED illuminated), the mains plug is correctly inserted, and the fuse is not defective. Refer to "Replacing Defective Fuse" if needed.

Insufficient Vacuum

Check vacuum regulator setting, tubing integrity, connection tightness, overflow protection status, suction jar/lid/disposable system condition, and filter for clogs. Contact technical department if unresolved.

Replacing Defective Fuse

WARNING: Disconnect the power plug before replacing the fuse. Refer to the service manual for instructions on replacing fuses (T 1.6AH, 250 VAC, 5x20mm).

General Reprocessing Guidelines

WARNING: Wear gloves. Parts in contact with secretions must be cleaned, disinfected, sterilized, or disposed of according to instructions. Disconnect power before cleaning.

General Principles:

• The product is delivered non-sterile and must be cleaned and disinfected before first use and after each use.
• If used on a patient with pathogens resistant to standard procedures, the device must be disposed of.
• Follow manufacturer instructions for cleaning/disinfection agents regarding mixing ratios and dwell times.
• Use validated cleaning and disinfection procedures.
• Do not use disinfectants containing phenols, chlorine, or peracetic acid without corrosion protection.

Reprocessing Steps:

1. Disassembly: Separate all parts.
2. Manual Cleaning: Wipe external surfaces with a lint-free wipe moistened with water (<40°C). For manual cleaning before disinfection, use a validated cleaning/disinfectant wipe (e.g., CaviWipes™, Incidin OxyWipe S™), ensuring all surfaces are clean.
3. Manual Disinfection: Wipe all surfaces with a disinfectant wipe, ensuring surfaces remain visibly moistened for the specified dwell time. Remove residuals with a lint-free wipe moistened with purified water.
4. Drying and Inspection: Dry external surfaces with a lint-free cloth or medical-grade compressed air. Inspect for remaining soil or disinfectant.
5. Automatic Cleaning: Use an automatic washer-disinfector with a validated procedure and alkaline cleaner (e.g., neodisher® MediClean forte). Ensure parts are fixed and properly exposed to cleaning liquids. Do not use drying aids in the final rinse.
6. Automatic Disinfection: Thermal disinfection with purified water at 90°C for 1 minute (A0=600) or as per local regulations.
7. Sterilization: Conduct steam sterilization using a fractional pre-vacuum cycle (e.g., 132-134°C for 3-4 mins, 20-30 mins drying). Ensure packaging conforms to DIN EN ISO 11607-1.
8. Visual Inspection after Reprocessing: Check sterile packaging for damage and remaining water.
9. Storage: Store sterile packaging in a dry, clean, dust-free environment.

Note: Specific reprocessing instructions for parts like PSU jars, lids, tubing, filters, and VAD cups are detailed in the document, often referencing specific product codes and validated agents.

Warranty and Servicing

Warranty

Medela AG warrants the device against defects in materials and workmanship for 5 years from delivery. This excludes parts subject to wear and tear. Exclusive use of Medela accessories is recommended. Medela is not liable for consequential damages from incorrect operation, misuse, or unauthorized repairs.

Servicing/Routine Check

Maintenance must be performed by authorized personnel. Medela recommends an annual routine check as per the service manual.

Disposal

Handle and dispose of products according to medical practice and local regulations. Reprocess reusable devices before disposal. Pump and electrical parts should be disposed of according to WEEE directive (EU) 2012/19/EU, collected separately from municipal waste. The manufacturer or vendor must take back waste equipment in the EU/Switzerland/UK.

Accessories Overview

A wide range of accessories are available, including various tubing types (disposable sterile/non-sterile, silicone), collection systems (jars, lids, liners), filters, foot controls, VAD cups, and holders. It is crucial to use only Medela-verified accessories for correct and safe operation. Third-party patient interfacing devices (cannulas, catheters) must have CE marking and be compatible.

Technical Specifications

• High Vacuum: -95 kPa / -713 mmHg (Tolerance: ±15%)
• High Flow: 40, 50, or 60 l/min (Tolerance: +10 l/min)
• Weight: 9.3 kg (20.5 lbs)
• Power: 100–240V, 50/60Hz, 120W
• Dimensions (Rack version): 210x305x375 mm (8.2x12.0x14.8 inches)
• Certifications: ISO 13485, CE (93/42/EEC), IIa

EMC Information

The Dominant Flex is EMC-tested according to IEC 60601-1-2. It requires special safety precautions regarding electromagnetic compatibility. It is approved for professional healthcare and home healthcare environments. Use only specified accessories. Avoid use adjacent to or stacked with other equipment. Electromagnetic emissions are low (Class B), and immunity tests confirm compliance with typical environments. Guidelines are provided for separation distances from portable and mobile RF communication equipment.

Signs and Symbols Glossary

The document includes a glossary of symbols used, such as:

• CE Mark: Compliance with EU medical device requirements.
• UL/CSA Mark: Compliance with USA/Canada safety requirements.
• [Read and follow instructions for use] symbol.
• [General safety alert] symbol.
• [Safety related tip] symbol.
• [Earth/Ground] symbols.
• [Type CF applied part] symbol.
• [MRI Unsafe] symbol.
• [Equipotential conductor] symbol.
• [Manufacturer identification], [Date of manufacturing], [Expiration date].
• [Single-use] symbol.
• [Part number], [Serial number], [Batch code].
• [Temperature range], [Humidity range], [Atmospheric pressure range].
• [Do not use if package is damaged] symbol.
• [WEEE disposal] symbol.
• [Fragile goods] symbol.
• [Fuse] symbol.
• [Model number] symbol.
• [Sterilization symbols] (Ethylene Oxide, sterile barrier systems).
• [UDI - Unique Device Identifier] symbol.
• [RF identification tag] symbol.
• [Authorized representative] symbol.