medela Basic Surgical Suction Pump Instruction Manual

medela Basic Surgical Suction Pump

INSTRUCTIONS FOR USE

WARNINGS AND SAFETY INSTRUCTIONS

WARNINGS
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTIONS
Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury.

SAFETY RELATED TIP

Indicating useful information about the safe use of the device. The Basic is approved exclusively for the use as described in these instructions for use. Medela can only guarantee the safe functioning of the system when the Basic is used in combination with the original Medela accessories (collection system, tubings, filters etc. – see chapter “Accessories overview”).

IMPORTANT NOTE

• Please read and observe these warnings and safety instructions before operation. Please also familiarize yourself with associated information signals and troubleshooting instructions before operation (see chapter “Installation” and “Troubleshooting”). These instructions for use must be kept with the device for reference.

• Please note that these instructions for use are a general guide for the use of the product. Medical matters must be addressed by a physician. Compliance with proper surgical procedures and techniques is the responsibility of the physician. Each physician must evaluate the appropriateness of the treatment based on his own knowledge and experience. Medela is only responsible for the effect on basic safety, reliability and performance of the Basic if it is used in accordance with the instructions for use.

• Compliance with proper surgical procedures and techniques is the responsibility of the physician. Each physician must evaluate the appropriateness of the treatment based on his own knowledge and experience.

• Any serious incident that has occurred in relation to the device must be reported to Medela AG and the relevant Competent Authority.
  CAUTION : U.S. Federal law restricts this device to sale by or on the order of a physician. Subject to change.

• WARNINGS

• For use only by medically trained persons who have been adequately trained in suction procedures and in the use of aspirators.

• To avoid risk of electric shock, this equipment must only be connected to a power socket with protective ground.

• The device must not be used for suctioning explosive, easily flammable or corrosive liquids

• The connecting tubing supplied with the device must never come into direct contact with the suction area. A sterile suction catheter must always be used (risk of infection).

• Before cleaning the device, pull the plug out of the power socket.

• No modification of this equipment is allowed.

• Consult the indications for use and consider risk factors and contraindications before using the Basic. Failure to read and follow all instructions in this manual prior to use may result in serious or fatal injury of the patient.

• Not suitable for setting at a low vacuum, as needed for example for thoracic drainage without specialized accessories. Not approved for outdoor use or transport applications.

• Do not connect this device to a passive drainage tube. Do not use anti-static tubing to connect the endoscope to the suction pump as patient safety may be compromised.

• The Basic pump may shortly shut down with electrostatic discharge (ESD) events at the DC port of 15kV.

CAUTIONS

• Incorrect use can cause pain and injury to the patient.
• Do not use sterile accessories when the sterile packaging is damaged.
• Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walki-talkie can affect the Basic pump and should be kept at least a distance 1ft (30cm) away from the equipment.
• The rack version requires a minimum distance of 5cm to the enclosure to prevent overheating of the device. The back of the enclosure must be open.
• The patient should be monitored regularly according to the physician’s instructions and facility guidelines. Objective indications or signs of a possible infection or complication must be reported immediately (e.g., fever, pain, redness, increased warmth, swelling or purulent discharge). Non-observance can lead to considerable danger to the patient. Monitor the Basic frequently for operat ing status.
• To prevent the device from overheating, the exhaust at the bottom of the unit must be unobstructed when the unit is operational.

SAFETY RELATED TIP

• For safety tests, the suction pump requires service and repair throughout its service life in accordance with the service manual.
• The protection of the Basic against the effects of the discharge of a cardiac defibrillator is dependent upon the use of appropriate cables.
• Separation from electrical power is only assured through the disconnection of the mains plug and the fixed mains socket.
• Third party interfacing devices (e.g. cannulas, catheters) must be able to be attached without impacting the performance of the pump.
• Ensure proper performance of the suction pump prior to use, see section on preparation for use
• Avoid contact of fluids with the ends of the mains plug or appliance inlet port.

SAFETY INSTRUCTIONS

• Please consult the IFU of the devices for use with the Basic for any contraindications in the specific indications for use.
• Wear gloves for all operations.
• The Basic is a medical device that requires special safety measures in regard to EMC. It must be installed and put into operation in accordance with the EMC information in chapter “Technical documentation”.
• The Basic is Magnetic Resonance (MR) Unsafe. Do not take the pump into the MR environment.
• In the case of overflow, inform the internal technical service immediately and perform the tasks in the service manual.
• In each of the following cases, the device must not be used and it must be repaired by Medela Customer Service:
• if the power cord or the plug is damaged
• if the device is not functioning perfectly
• if the device is damaged
• if the device shows clear safety defects.
• Keep the power supply cord away from hot surfaces.
• The mains plug must not come into contact with moisture.
• Never pull the mains plug out of the fixed mains socket by pulling on the power supply cord!
• Never leave the device unattended when it is switched on.
• The pump must stand upright during use.
• Never use the device at high room temperatures, if you are very tired or in an environment where there is a risk of explosion.
• Never place the device in water or other liquids.
• When using single use, sterile products, please note that they are not intended to be reprocessed. Reprocessing could cause loss of mechanical, chemical and/or biological characteristics. Reuse could cause cross contamination.
• Contact your local Medela customer service representative for assistance with product operations.
• Use the Medela suctioning equipment for the removal of bodily fluids only. Do not use Medela suctioning equipment for the administration of bodily fluids. These  instructions for use must be kept for later reference.

DESCRIPTION

Introduction

The Basic is a high-quality suction pump, which provides maximum suction performance for many suctioning needs. It ideally combines easy handling and reprocessing with safety features to ensure optimal operation. You can choose from a comprehensive range of accessories from Medela to configure the pump to many medical applications.

Intended use/indications

The intended use of the Basic suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass, and epicardial ablation probes.

Intended user
The Basic should only be operated by properly trained staff. These persons must not be hard of hearing or deaf and must have adequate visual faculty. The training should be refreshed at least once a year.

Intended patient population
The Basic is intended to be used on patients only exhibiting conditions as described in the indications for use.

Contraindications
When used for epicardial ablation: Do not apply suction over an artery or aneurismal tissue. When used for off-pump coronary artery bypass: Do not position the tissue stabilizers over a coronary artery, newly infarcted or aneurysmal heart tissue. Do not attach stabilizers/positioners to: newly infarcted tissue, aneurysmal tissue, directly over a coronary artery, fragile tissue.

Important note
Compliance with proper surgical procedures and techniques is the responsibility of the physician. Each physician must evaluate the appropriateness of the treatment based on his own knowledge and experience.

OVERVIEW

Definition of vacuum
In the application of medical aspiration devices, vacuum is normally given as the difference (in absolute figures) between absolute pressure and atmospheric pressure or as negative values in Kilopascal (kPa). In this document, the indication of –10 kPa for example always refers to a pressure range in kPa below atmospheric ambient  pressure (according to terms and definitions of EN ISO 10079:1999).

Versions and main elements of the suction pump

INSTALLATION

Check initial delivery
Check the delivery package of the Basic for completeness and general condition.

Remove transport lock

1. Remove the red note.
2. Remove 3 screws and store them for later use

Set up mobile version (if available)

1. Position top part of trolley on bottom part, making sure the tubing fits as shown.
2. Connect parts with 4 screws.
3. Position pump on trolley. Make sure that the front of the pump and the standard rail point forward.
4. Connect pump with 4 screws.
5. Attach the cable holder with the two screws to the pump

Assembly of the optional clampholder (when using the optional trolley)

1. Press and hold the blue release knob.
2. Attach the clampholder to the standard rail by releasing the blue knob.

Set up the Safety Set

1. Attach the mechanical overflow protection to the lid. Pull gently downwards to make sure it is open/ deactivated.
2. Attach the lid to the jar.
3. Close the two lid clamps.
4. Attach the safety set to the pump.
5. For reprocessing, remove the safety set from the pump and disassemble by reversing steps 1.3, 1.2, and 1.1

PREPARATION FOR USE

WARNING

• For use only by medically trained persons who have been adequately trained in suction procedures and in the use of aspirators.
• CAUTIONS
• The Basic must remain in an upright position during use.
• The rack version requires a minimum distance of 2.5in (5cm) to the enclosure to prevent overheating of the device.
• Sterile accessories must be checked to ensure the integrity of the packaging before use
• Non-sterile and reusable accessories must be cleaned, disinfected and/or sterilized according to the Medela reprocessing instructions (product code 200.6522).

Check before use

• Check the Basic system before use for damage of the power cord or plug, obvious device damage or safety defects and proper functioning of the device.
• Check for completeness and general condition of the Basic delivery package.
• Check all accessories prior to use:

1. suction jars, lids and liners for cracks, brittle and flawed spots. Replace if necessary.
2. Tubing for cracks, brittle areas and that connectors are firmly attached. Replace if necessary.
3. As an additional safety test, evacuate the system (including jars) to maximum vacuum before actual use.

Assembly of the basic configuration

1. Make sure that the Safety Set is attached to the Basic. See chapter “Installation” and “Set up the Safety Set”.
2. If required attach a filter to the Safety Set with the arrow pointing in the flow direction.
3. Attach all necessary accessories according to your needs. See “Accessories overview”.

Assembly of the optional foot switch

1. Connect the optional foot switch to the pump by plugging in the plug.
2. Test the correct functioning of the foot switch.

Assembly of collection systems
Please refer to the instruction sheets of the Medela Disposable Collection System, Medela Reusable Collection system and Medela Disposable filter provided with the associated articles to find the assembly instructions and all information related to the use of the accessories and collection system.

OPERATING INSTRUCTIONS

CAUTION: The Basic is to be set up in such a way, that a separation from the mains supply can be easily managed.
Note: Wear gloves for all operations.

Connect the Basic to electical power

1. Check the pump before use following the instruction in chapter “Preparation before use”.
2. Connect the power cord to the appliance inlet at the back of the suction pump. Use the mounting bracket to secure the cord in the inlet port.
3. Plug in the mains plug of the power cord to a fixed mains socket.
4. An internal self-test is performed. When the green LED lights up, the device is ready for use.

Verify maximum vacuum

1. Turn the vacuum regulator to the right to set maximum vacuum.
2. Seal the end of the patient tubing with your thumb.
3. Compare the maximum vacuum according to the specification (below). See chapter “Troubleshooting” and “Insufficient vacuum” if vacuum is not reached.

WARNING: The device must not be used for suctioning explosive, easily flammable or corrosive liquids
CAUTION: When the Basic is used for drainage of bodily fluids or infectious materials from wounds, the negative pressure should be set according to the instructions of the special-ist so as to not cause any wound damage.

Changing vacuum level

1. Clamp patient tubing.
2. Turn vacuum regulator to select the correct vacuum according to the particular application. To increase vacuum turn regulator clockwise.
3. Check vacuum gauge for setting.

Placing out of operation after use

1. Touch on/off button to switch off the suction pump.
2. Disconnect the mains plug from electrical power source.
3. Clean and disinfect the Basic. See chapter “General Reprocessing Guidelines”.

VACUUM ASSISTED DELIVERY SETUP

CAUTION
The Basic is to be set up in such a way, that a separation from the electrical power supply can be easily managed.

1. If OK, release vacuum by returning foot vacuum regulator to resting “zero vacuum or ambient pressure” state (rear and down using heel of foot).
2. The pump is now ready for use.

TROUBLESHOOTING

Insufficient vacuum

Verify that:

• the vacuum regulator is set correctly.
• the tubing is not defective or broken. If necessary, replace.
• all plug-in connections are tight.
• the overflow protection is deactivated/open. If the overflow protection is activated, deactivate it as shown under chapter “Installation” and “Set up the Safety Set”.
• the suction jar and lid have no cracks, brittle areas, discoloration. If necessary, replace.
• the disposable system has no cracks, brittle areas, discoloration. If necessary, replace.
• the filter is not clogged. To test if the filter is clogged, refer to instruction sheet provided with the filters. If the issue cannot be resolved, contact the internal technical department.

No LED lit
The Basic is not connected to electrical power or the fuse needs replacement.

Yellow LED indicator lit
Minor case: yellow LED indicator lit but the pump can be switched on and off:

• contact the internal technical department or your authorised service center at next possible occasion. Major case: yellow LED indicator lit and pump cannot be switched on and off:
• contact the internal technical department or your authorised service center for repairs/maintenance.

Motor not running
Verify that:

• the Basic is switched on. The standby LED must be illuminated.
• the mains plug is inserted correctly into the fixed mains socket and into the appliance inlet.
• the fuse on the back of the Basic is not defective. For replacing the defective fuse follow chapter “Replacing defective fuse”. If the issue cannot be resolved, contact the internal technical department.

REPLACING DEFECTIVE FUSE

WARNING: Before replacing the fuse, pull the power plug out of the power socket. Please follow the instruction in the service manual [ 200.6366], how to replace fuses (T 1.6AH, 250 VAC, 5x20mm) of the Basic pump.

GENERAL REPROCESSING GUIDELINES

WARNING: After each use, the parts that have been in contact with the aspirated secretions are to be cleaned, disinfected, sterilzed or disposed of according to reprocessing instructions.

 | PS

wa ho

| U jars, reusable lids, clamps, overflow protection, O-rings (in case of spill thereon), ll holders and PC jars (in case of a spill), connectors (disassembled from tubing), lders, locking clasp
---|---|---
 | Silicone tubing (up to 200 cm only), change over valve (in case of a spill)
 |  Pump housing, cables, foot switch, foot vacuum regulator, wall holders, trolley, PC jars
Additional information| x| x| x| – Per ISO 17664-2, these instructions have been validated by the manu- facturer of the medical device as being capable of preparing a medical device for reuse. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials and personnel in the processing facility,achieves the desired result.

This requires verification and/or validation and routine monitoring of the process.

– For specification of water qualities see AAMI TIR34.

x| x|  | – The washer-disinfector shall be qualified according to ISO 15883 series; cleaning and disinfection was validated in an ISO 15883 certified washer- disinfector of an accredited lab.

– All disassembled parts must be safely fixed in the carriers/on fixation points.

– Do not overload the washer-disinfector. Arrange the disassembled parts in such a way that no areas are left unwashed and inner and outer surfaces are reached by the cleaning liquids.

Limitations| x| x| x| – Discard or service the device (or component as applicable) if it shows visible signs of wear or damage.
General safety instructions| x| x| x| – Always wear personal protective equipment (PPE): disposable gloves and other PPE as per local guidelines and regulations.

– Point-of-use treatment with tap water (≤40 °C, ≤104 °F). Violation of this may result in the fixation of residue and thus inhibit disinfection.

x| x| x| – If the device is used on a patient who suffers from a disease, and whose pathogens cannot be eliminated with procedure outlined below,

the device must be disposed of.

– Consult the cleaning and disinfection agent manufacturer’s instruction for use regarding, including but not limited to exposure times and safety measures.

– Perform point-of-use treatment directly after use of the device (before soil can dry onto the device).

 |  | x| – Disconnect the power cord from the electrical power source.

– Avoid contact of fluids with the ends of the mains plug or appliance inlet port.

– Never immerse the device in or rinse with water or other liquids.

Do not spray cleaning agent and disinfectant directly on the device.

Preparation before cleaning|  | x| x| – Wipe external surfaces of the device to remove all gross soil with

a soft, lint-free wipe moistened with tap water. Take care to wipe away from difficult-to-clean (and disinfect) areas, such as crevices, dead ends, and complex geometry.

 | x|  | – In case of contamination on the lumen of the tubing with connectors or on the mating area between connector piece and hose (if the connector cannot be removed), or in the channels of the change-over-valve, dispo- se of the device per applicable procedures for contaminated material.
x|  | x| – Disassemble into individual parts before proceeding (see installation instructions).

– Remove connector piece(s) from hose of tubing if they are soiled.

– Remove O-rings from connector piece if they are soiled.

– Carefully open the Torx Screw on the holder, compress the spring by pressing the button. After removing the screw, slowly release the push button. Next, remove the push button and the spring. Then remove the lower claw by closing the clamp and then pulling.

x|  |  | – If necessary, and for the removal of gross soil, place the disassembled components in tap water for 10 minutes and wipe off visible staining with a soft, lint-free wipe soaked in tap water.
x| x|  | – If residual soil has dried onto the device, the soil must be rehydrated before the enzymes can be effective.
Manual cleaning|  |  | x| – Wipe all external surfaces of the device with CaviWipes™ or Incidin OxyWipe S™.

– Wipe away from difficult-to-clean areas (e.g., where components that cannot be disassembled meet).

– Use a new cleaning and disinfectant wipe when the wipe is contaminated.

– Clean until all visible soil is removed.

Manual disinfection|  |  | x| – Take a new CaviWipes™ or Incidin OxyWipe S™ wipe and wipe all external surfaces of the equipment.

– Pay special attention to the difficult-to-clean areas of the device.

– After 3 minutes, take a new CaviWipes™ or Incidin OxyWipe S™ wipe and wipe all external surfaces of the equipment.

– To aid exposure of difficult-to-clean areas, a new CaviWipes or Incidin Oxy Wipe S wipe may be wrapped around a spatula or a similar utensil.

– Make sure all surfaces of the device remain visibly moistened at room temperature for the time specified in the wipe manufacturer’s instructions for use. If the used wipe is getting too dry to moisten the surface use a new wipe.

– After the prescribed exposure, remove any residuals using a soft, lint-free wipe moistened with purified water.

Automated cleaning| x| x|  | – Connect tubes to the active rinsing system of the load carrier to ensure the rinsing of the inside and outside.

– Place lids on straight nozzle through inlet (patient side).

– Position all other devices in the load carrier.

– If applicable, position the carrier for small parts on the load carrier.

– Do not use any drying aids (rinsing agents) as these could remain on the surface with a detrimental effect to the device and its biocompatibility.

The cleaning program of the washer-disinfector should adhere to the following:

– 1 minute pre-cleaning with tap water

– 5 minutes cleaning at 55 °C with 0.5 % solution of neodisher® MediClean forte in tap water

– 1 minute rinsing with purified cold water

Autom. disinfect.| x| x|  | – Thermal disinfection with purified water (without an additional agent) at 90 °C for 1 minute (A0=600) or adapt A0 values per local guidelines and regulations.
Drying| x| x|  | – Dry disassembled components in washer-disinfector at 110 °C for at least 45 minutes.
x| x| x| – If drying in the washer-disinfector is not possible or in case of residual moisture, wipe external surfaces dry using a dry, soft lint-free wipe,

or carefully dry with medical grade compressed air.

– Pay special attention to the dryness of hard to reach areas.

Inspection| x| x| x| – Visually inspect the device or disassembled components for any remaining soil or disinfectant solution. If necessary, repeat the cleaning and disinfection.

– Visually inspect the device or disassembled components for damage.

In case of any damage to one or more parts, replace them with new ones.

x|  | x| – Consult the installation section in this IFU for guidance on reassembly.
 |  | x| – Perform full service or routine check as indicated in this IFU.
Storage| x| x| x| – Always store device in a dry, clean, and dust free environment.
Transport|  |  | x| – Reprocess the device before sending it in for service. If this is not possible or can only be done in parts, the package shall indicate the potential biohazard. Local procedures and guidelines apply.
x| x| x| – Take appropriate measures to ensure intactness of the device or the components and to safeguard against re-contamination until use as per local guidelines and regulations.

WARRANTY AND SERVICING

Warranty
Medela AG warrants the device will be free from defects in materials and workmanship for a period of 5 years from the date of delivery. Faulty material will be replaced free of charge during this period if not resulting from abuse or misapplication. This will not apply to parts subject to wear and tear in use. To ensure compliance with this warranty as well as optimum service from Medela products, we recommend the exclusive use of Medela accessories with our pumps. In no event shall Medela AG be liable for claims which exceed the scope of warranty described including liability for consequential damages, caused by incorrect operation, inappropriate use, unauthorized repairs or inappropriate assembly or disassembly. The right to the replacement of faulty parts will not be recognized by Medela if any work has been carried out on the pump by unauthorized persons. This warranty is subject to the device being returned to a Medela service centre.

Servicing/routine check
Maintenance and service work on the suction pump, its modules or accessories must only be performed by authorised maintenance personnel who have been trained. Medela recommends to carry out the routine check 1x per year according to the Medela service manual [ 200.6366], which is available in English upon request.

DISPOSAL

• Handle and dispose of all products in accordance with accepted medical practice and with applicable local guidelines and regulations.
• Reprocess reusable devices prior to disposal. Autoclave accessories that are contaminated with body fluids.

Pump and electrical parts

• Inquire at the point of sale or contact your local authority for appropriate collection points for waste equipment.
• The Basic should be disposed of in accordance with the European directive 2012/19/EU WEEE.
• Do not dispose of electrical or electronic equipment together with unsorted municipal waste, collect it separately instead.
• In the European Union/Switzerland/UK the manufacturer or its vendor must take back waste equipment. Other countries may have similar collection and recycling systems. Please respect the relevant state laws and rules in your country for the disposal of electrical and electronic equipment.
• The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment.

ACCESSORIES OVERVIEW

WARNINGS

• The Basic was verified in combination with the accessories listed below. For correct and safe operation, use the Basic with these accessories only. Further information is supplied on the instruction sheet of the individual accessory.
• Do not connect to passive drainage tubes.

SAFETY RELATED TIP

• A selection of various cannulas is available from different manufacturers. They vary in tip styles, tip shapes, lengths and diameters, straight or curved, 077.0523 077.0531/32 with or without vent holes. A cannula with FDA-certified materials must be used in combination with the Basic. Cannula manufacturers may include: Byron Medical, Inc, and Tulip Medical, Inc. If the pump is used together with third party patient interfacing devices (e.g., cannulas, catheters), they must:

• have the CE label and (if necessary) local registration.

• be able to be attached to Medela accessories safely without impacting the performance of the pump.
  Tubing connection on reusable lids of jars: Ø 6–10mm, Ø 10–14mm Tubing connection on disposable liners: Ø 6.5–11mm

• Note: When combining Medela parts and a new patient interfacing device, you take on the responsibility for the entire system and should test the combination to ensure the vacuum levels are properly maintained.

Connectors

Reusable lids

Reusable sets

Accessories for high volume setups

Wall holders

TECHNICAL SPECIFICATIONS

SIGNS AND SYMBOLS

TECHNICAL DOCUMENTATION

EMC
The Basic is EMC-tested in conformity with the requirements of IEC 60601-1-2:2014/AMD1:2020 Edition 4.1 according to clause 7 and 8.9. The Basic is a medical device that requires special safety precautions and must be installed and placed in operation in accordance with the EMC information. The Basic does not have an essential performance as defined in IEC 60601-1.

WARNINGS

• Do not use other accessories than those specified or sold by the manufacturer as replacement parts for internal components as it may result in increased emissions or decreased immunity of the Basic pump. HF (high-frequency) surgical equipment, radio networks or the like can influence the operation of the device and may not be operated in combination with the Basic pump.
• Basic should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, Basic should be observed to verify normal operation in the configuration in which it will be used.

Electromagnetic emissions
The Basic is only approved for the following electromagnetic environments: professional healthcare facility environment and home healthcare environment.

Emission Tests| Compliance| Electromagnetic environment – guidance
---|---|---
RF emissions CISPR 11| Group 1| The Basic uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference with nearby electronic equipment.
RF emissions CISPR 11| Class B| The Basic is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions

IEC 61000-3-3

| Complies

Electromagnetic immunity
The Basic is only approved for the following electromagnetic environments: professional healthcare facility environment and home healthcare environment.

Immunity Tests

Electrostatic Discharge (ESD) IEC 61000-4-2

| IEC 60601-1-2

test level

± 8 kV contact

± 15 kV air

| Compliance level

± 8 kV contact

± 15 kV air

| Electromagnetic environment

– guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

---|---|---|---
Electrical fast transient/burst IEC 61000-4-4| ± 2 kV

for power supply lines

± 1 kV

for input / output lines

| ± 2 kV

for power supply lines

± 1 kV

for input / output lines

| Mains power quality should be that of a typical commercial or hospital environment.
Surge

IEC 61000-4-5

| ± 1 kV

differential mode

± 2 kV

line-to-earth

| ± 1 kV

differential mode

± 2 kV

line-to-earth

| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 0 % U T

for 0.5 cycle at 0°,

45°, 90°, 135°, 180°,

225°, 270° and 315°

0 % U T

for 1 cycle

70 % U T

for 25 cycles at

50 Hz single phase: at 0°

and for 30 cycles at 60 Hz single phase: at 0°

0 % U T

for 250 cycles

at 50 Hz

and for 300 cycles at 60 Hz

| 0 % U T

for 0.5 cycle at 0°,

45°, 90°, 135°, 180°,

225°, 270° and 315°

0 % U T

for 1 cycle

70 % U T

for 25 cycles at

50 Hz single phase: at 0°

and for 30 cycles at 60 Hz single phase: at 0°

0 % U T

for 250 cycles

at 50 Hz

and for 300 cycles at 60 Hz

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the Basic requires continued operation during power mains interruptions, it is recommended that the Basic be powered from an uninterruptible

power supply or a battery.

Power frequency (50/60 Hz)

magnetic field IEC 61000-4-8

| 30 A/m| 30 A/m| Power frequency magnetic fields should be at levels of a typical commercial or hospital environment.
Proximity magnetic fields

IEC 61000-4-39

| 8 A/m

30 kHz – CW

65 A/m

134.2 kHz –

PM 2.1 kHz

7.5 A/m

13.56 MHz –

PM 50 kHz

| 8 A/m

30 kHz – CW

65 A/m

134.2 kHz – PM

2.1 kHz

7.5 A/m

13.56 MHz –

PM 50 kHz

| Magnetic field intensity should be that of a typical or commercial or hospital environment.

Electromagnetic immunity
The Basic is only approved for the following electromagnetic environments: professional healthcare facility environment and home healthcare environment.

Immunity Tests| IEC 60601-1-2

test level

| Compliance level| Electromagnetic environment – guidance
---|---|---|---

Conducted RF IEC 61000-4-6

|

3 Vrms

0.15–80 MHz

|

3 Vrms

| Portable and mobile RF communication equipment should be used no closer to any part of the Basic, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

6 Vrms in ISM and amateur radio bands between 0.15

and 80 MHz

|

6 Vrms

| Recommended separation distance

d = 1.2 √ P d = 0.35 √ P

80 MHz to 800 MHz

Radiated RF IEC 61000-4-3| 10 V/m

80 MHz to

2.7 GHz

| 10 V/m| d = 0.7 √ P

800 MHz to 2.7 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
NOTE 3: Proximity fields from RF wireless communication equipment were tested according to Table 9 of IEC 60601-1-2:2014/AMD1:2020

• Field strengths from fixed RF transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To 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 Basic are used exceeds the applicable RF compliance level above, the Basic should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as reorienting or relocating the Basic.
• Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Table of frequencies
Table of frequencies of portable and mobile transmitters for which the recommended separation distance is 30cm (12 inches):

Band (MHz)

• 380–390
• 430–470
• 704–787
• 800–960
• 1700–1990
• 2400–2570
• 5100–5800

Service

• TETRA 400
• GMRS 460, FRS 460
• LTE Band 13, 17
• GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5
• GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25;
• UMTS
• Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 WLAN 802.11 a/n.

ADDRESSES
International Sales
Medela AG
Lättichstrasse 4b
6340 Baar

Switzerland
Phone +41 41 562 51 51
Fax +41 41 562 51 00
customercare@medela.ch

Canada
Medela Canada Inc.
4160 Sladeview Crescent Unit # 8
Mississauga, Ontario
L5L 0A1
Canada
Phone +1 800 435 8316
Fax +1 800 995 7867
info@medela.ca

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