ardo Master Suction Pump Instruction Manual

Suction category		high vacuum / high flow
Suction power max.	Master	50l/min ±15%
Suction power max.	Senator	30l/min ±15%
Vacuum meter		0 to -100kPa / 0 to -700mmHg / ±2.5%
Vacuum regulator		mechanically, continuously 0 to maximum
Vacuum level max. at	2’000m a.s.l.	-72kPa / -540mmHg / ±5%
	1’000m a.s.l.	-84kPa / -630mmHg / ±5%
	500m a.s.l.	-89kPa / -668mmHg / ±5%
	0m a.s.l.	-95kPa / -713mmHg / ±5%

Classification

Protection class	Class I with protective earth ground
Degree of protection	BF
Classification according Regulation (EU) 2017/745	IIa
Foot switch IP-degree of protection	IPX2

Conformity for 230VAC devices

Concerning Regulation (EU) 2017/745

on medical devices 0123

EN 60601-1 / EN 60601-1-2 / EN 60601-1-6 / EN 62366-1 / EN ISO 10079-1 / EN ISO 14971

Conformity for 115VAC devices

With respect to electric shock, fire, and mechanical hazards, only in accordance with UL 2601-1 / 52YA. With respect to electric shock, fire and mechanical and other specified hazards, only in accordance with CAN/CSA C22.2 No.601.1, (CAN/CSA 601.2XX, if

applicable) Medical equipment certified for Canada 52YA E218915.

ardo-Master-Suction-Pump-fig (22)

Operating conditions

Ambient temperature	+10 – +40°C
Relative humidity	30 – 75%RH non-condensing
Atmospheric pressure	700 – 1060hPa

Storage- and Transport conditions

Ambient temperature	-20 – +50°C
Relative humidity	10 – 95%RH non-condensing
Atmospheric pressure	500 – 1060hPa

Dimensions and weight of the device

Width x Depth x Height [W x D x H]	250 x 285 x 335mm
Weight	7.4kg

Dimensions and weight of device with trolley

Width x Depth x Height [W x D x H]	560 x 450 x 981mm
Weight	18.1kg

Dimensions and weight of trolley

Width x Depth x Height [W x D x H]	560 x 450 x 660mm
Weight	10.7kg
Castors	Ø 75mm
Ground clearance	125mm

INTRODUCTION

Before connecting the device to the electrical mains supply, check that the mains supply voltage indicated on the type-label corresponds to the mains supply voltage at the socket. For the operator’s and the patient’s safety and to prevent damage, the following safety instructions and precautions must be observed.

General safety instructions

The device is designed solely for the applications described in the Operating Instructions. Safe function can only be assured if original accessories and original spare parts from Ardo medical are used (e.g. hydrophobic bacterial filter, suction jars, tubing, etc.).
The device complies with the requirements of EMC standard EN 60601-1-2 and may be used in the vicinity of other devices tested in accordance with this EMC standard. Untested radio networks, high frequency sources, mobile phones and the like may affect the functioning of the device.
The device is not designed for use in conjunction with magnetic resonance; do not operate the device in the vicinity of magnetic resonance.
Only connect the device to an electrical mains supply with protective earth ground.
Do not use extension cables.
The device is only completely separated from the mains supply when the mains power cable is disconnected from the mains supply socket.
During its service life, the device must be maintained periodically according to the Service Instructions.
This device may not be modified without the permission of the manufacturer. Any other electrical devices being used must also be electrically safe.
The device may only be opened by the technical personnel;
Failure to comply may result in electric shock!
These Operating Instructions must be saved and be available to the user and Technical Service at all times.

Precautions

The device may only be used by medically trained personnel who are sufficient trained in the use of suction devices and suction technology.
Before use, the functional safety and the specified conditions of the device must always be checked. In the event of functional defects, which represent a risk for the patient or user, the device must not be operated or continue to be operated.
The device generates a high vacuum and high flow.
To protect against overflow, only operate the device with the hydrophobic bacterial filter from Ardo.
Stop operating a device with an overflow; disconnect the mains power cable from the mains supply and contact Technical Service.
The non-sterile connection tube supplied with the device must not come into direct contact with the suction area due to the risk of infection; a sterile suction catheter must always be used for this purpose. Not included in the scope of delivery. The sterile suction catheter must fit the inner diameter of the patient tubing. The functional check in section 4.6, must also be run to check for leakage.
The device is not designed to be used in environments where there is a danger of explosion.
The device is not designed to aspirate flammable, corrosive or explosive liquids.
To protect against overheating, only operate the device once the rubber feet have been fitted. The openings for ventilation and exhaust air are located on the bottom of the housing. Do not cover the top of the device with towels or the like; the air outlet for ventilation of the device is below the handle integrated into the housing.
If the device is mounted on a trolley, ensure that the brakes are first released and then reapplied before moving and that thresholds are crossed with caution.

APPLICATIONS

Intended use
Electrical provision of a continuous vacuum between 0 and -95kPa / 0 to -700mmHg for use in the clinic, hospital and doctor’s medical practice. The device is designed for continuous operation. The vacuum provided by the device can be used, depending on the accessories, for example for:

Surgical Suction
Secretion Suction
Vacuum-Extraction
Endoscopy
Dental and Maxillary Surgery

Please note:
These Operating Instructions only contain general information for the use of the device. The correct application of the device performance and any accessories is the responsibility of the medically trained user.

Indication
The Master/Senator vacuum pump has no medical indication.

Contraindication
The Master/Senator vacuum pump has no medical contraindication. However, it must not be used in the following cases:

Cardiac surgery
Use on the central nervous system
Operation with a low, precise vacuum, such as for Thorax drainage
Domestic use
Outdoor use and in means of transport
When moved with mobile power sources

Notice to the user
In accordance with Regulation (EU) 2017/745 on medical devices, serious incidents that have occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user is established. The required user information is supplied to the customer together with the product in the form of Operating Instructions. A printed version of the Operating Instructions is included in the scope of delivery.

PRODUCT DESCRIPTION

Overview of Master and Senator

The suction power of Master corresponds to 50l/min, the suction power of Senator is 30l/min.
The housing is made of a robust, painted plastic material. The 2-cylinder pump unit is designed for very low noise and the combination of glass cylinder with graphite piston is maintenance-free. The pump unit is protected against contamination and overflow by a hydrophobic bacterial filter that is very easily changed. The vacuum meter shows a range of 0 to -100kPa / 0 to -700mmHg. The stepless vacuum regulator works as an air-leakage regulator.
The socket for the mains power cable, the device fuses and the connector for potential equalization are at the rear. The devices can be easily mounted on an optional trolley.

Carrying handle, integrated into the housing
Fitting rail on the housing
Mains switch ON / OFF
Hydrophobic Bacterial Filter
Control knob for vacuum regulation
Vacuum meter 0 to -100kPa / 0 to -700mmHg, Class 2.5
Fitting rail on the trolley
Trolley with 4 castors, 2 of them antistatic with brake

Symbols on the device and their meaning

Symbols on the packaging and their meaning

Hydrophobic Bacterial Filter

The hydrophobic bacterial filter has a filtering capacity of 99.999% for particle sizes up to 3.3μm and provides effective protection in this range against contamination of the pump unit.
In the event of any overflow of the suction jar with liquid or foam, the hydrophobic material acts as a blocking filter and immediately blocks the vacuum flow. Any pollution and contamination of the pump unit is thereby prevented.
Discoloration of the white filter material indicates that the filter has been contaminated with liquid or foam and must be replaced.

INITIAL OPERATION

Before Initial Operation
Before initial operation and when in use, the brakes must be applied. Moving the pump together with the patient is prohibited.Before initial operation, check the following:

Mains supply voltage must have the same rating as marked on the type-label.
Mains power cable and mains plug must not be damaged.
Mains plug must fit properly in the mains socket.
Device and its connectors must not have any external damage.
Suction jars and their lids must not have any cracks, brittle or faulty spots.
Tubing and tubing connectors must not have any cracks, brittle or faulty spots.
O-rings on the vacuum connectors of the device, the hydrophobic bacterial filter, jar lid, etc. must not have any cracks, brittle or faulty spots and must be assembled correctly.

To avoid the risk of electric shock, this equipment must only be connected to a mains supply with a protective earth ground conductor. For operation, the device must be positioned so the device can be easily disconnected from the mains supply with the mains power cable. If one of the above items is not met, the device must not be operated.

Connections on the Device and Accessories Device back side

Connector for foot switch (optional)
Connector for potential equalization
Device fuses
Connector for mains suppl

Device front side

Connector for hydrophobic bacterial filter
Connector for 0.5m connection tubing to suction jar

Lid of suction jar

Connect the transparent angled coupling connector of the 0.5m connection tubing to the hydrophobic bacterial filter.
Connect the green angled coupling connector to the green male coupling on the lid of suction jar.
Connect the transparent angled coupling connector of the 1.7m patient tubing to the transparent male coupling on the lid of suction jar.

Change-over valve (optionally available)
With the change-over valve the vacuum of the pump can be switched manually from suction jar A to suction jar B.

To the vacuum connector of the vacuum pump.
From the vacuum connector of the suction jar
From the vacuum connector of the suction jar B
Change-over A to B
Clamp for fixing on a fitting rail

Instrument tray for fitting rail (optionally available)
Made of high-quality, stainless chromium steel, suitable for all fitting rails.

Foot-operated vacuum regulator (optionally available)
Use the control knob for vacuum regulation on the device to set the maximum desired vacuum for the application. Now the vacuum can be steplessly regulated by means of the foot operated vacuum regulator, up to this previously set maximum vacuum.

The vacuum connection of the foot operated vacuum regulator must be inserted between the pump and the hydrophobic bacterial filter. (This prevents any contamination of the foot operated vacuum regulator.)
Pedal holder for foot operated vacuum regulator (Optionally available for positioning the foot-operated vacuum regulator on the trolley).

If the foot operated vacuum regulator is contaminated through incorrect connection, failure to use the hydrophobic bacterial filter, overflow or any other cause, the foot operated vacuum regulator must no longer be used. The foot operated vacuum regulator must be disposed of by the user in accordance with local regulations.

Foot switch (optionally available)
The pneumatic foot switch allows switching the pump unit ON and OFF with the foot.

Push the pneumatic tube of the foot switch onto the connection nipple all the way to the limit.
Support for foot switch with integrated air tube winder, suitable for fitting rail. (Optionally available bracket for storing the footswitch when moving the pump or when not in use.)

Lid of suction jar and suction jar
The lid fits 1 liter, 2 liter and 5 liter suction jars from Ardo medical. The spring-loaded pressure pin with clamp allows quick mounting on a fitting rail. The float of the mechanical overflow safety device prevents overflow of a full suction jar.

Pressure pin
Pressure spring
Lid with handle
4x O-ring 8.1 x 1.6mm
Coupling connectors green and transparent
Seal for lid of suction jar
O-ring silicone 12.42 x 1.78mm
Retainer for float of overflow safety device
Float for overflow safety device
Clamp with threaded pin

The material of the suction jar consists of high quality polysulfone.

1 liter suction jar with graduation 100ml
2 liter suction jar with graduation 100ml
5 liter suction jar with graduation 200ml

Lid with handle and mechanical overflow safety device
1 liter suction jar
2 liter suction jar
5 liter suction jar

Trolley (optionally available)
To mount the device on the trolley, unscrew the four rubber feet on the bottom of the housing. Screw the device to the mounting plate with the screws from the four rubber feet; ensure that the front of the device matches the position of the castors with the brakes. Ventilation of the device without rubber feet is only ensured on the trolley. If the device is removed from the trolley, the rubber feet must be re-attached to the bottom of the housing to ensure ventilation. The device with trolley must only be moved with a maximum of one full 5-litre suction jar attached to the fitting rail of the trolley.

2x Hex socket flat countersunk head screw M5x10
1x Mounting plate
1x Fitting rail
2x Hex socket head cap screw M6x10
2x Protection plug
2x Hex socket head cap screw M6x40
2x Castor with brake, antistatic
2x Castor without brake

Operation, switching ON the device
The operating position for the user is the front side of the device. Controls and indications are located on the front side. For protection against overflow and contamination, only use the device with hydrophobic bacterial filter from Ardo medical. Before each use, check and inspect suction jars and lids of suction jars. Damaged or worn-out suction jars and lids of suction jars must not be used. In the event of unusual noise from the device, switch OFF the device and contact Technical Service.

Mains switch ON / OFF
Control knob for vacuum regulation

The device is connected to the mains supply. Switch ON the mains switch; the green indicator lamp in the mains switch must light up and the pump unit must run audibly

Switching ON the device and operating with foot switch
The device with foot switch option has a symbol for the foot switch and an orange LED for the operating state of the foot switch on the front of the device. The device is connected to the mains supply and the foot switch is connected to the device. Switch ON the mains switch, the green indicator lamp in the mains switch must light up. If the LED orange does not light up, the pump unit is switched ON by means of the foot switch. If the LED orange lights up, the pump unit is switched OFF by means of the foot switch.

Foot switch in position ON = LED orange does not light up
Foot switch in position OFF = LED orange lights up

Operating state of mains switch and foot switch

Mains Switch indicator lamp green	Foot Switch LED orange	Pump unit runs
–	–	–
	–
		–

At the end of an application, the running pump unit should be always switched OFF by means of the mains switch, not with the foot switch. This means, before switching OFF the device by means of the mains switch, the orange LED should not be lit; also see following remark.

Remark: If the pump unit is switched OFF by means of the foot switch at the end of an application,the next use of the device will be not possible without a foot switch. The pump unit would not run after being switched ON with the mains switch and would first require switching ON with the foot switch.

Functional check

Check the hydrophobic bacterial filter
With the device running and open vacuum connector on the hydrophobic bacterial filter, the vacuum meter should not indicate more than -20kPa (-150mmHg), otherwise replace the hydrophobic bacterial filter.

Check leakage
With the device running, clamp the patient tubing. Set the vacuum control knob to maximum vacuum. When maximum vacuum is indicated on the vacuum meter, switch OFF the device with the mains switch. If no noticeable drop in vacuum is visible on the vacuum meter, the system is tight. If the system is not tight, check the vacuum connections from the patient tubing to the device, one after the other – any missing, defective or cracked O-rings must be replaced. Also check that the seal for lid of suction jar and the lid of suction jar is correctly assembled on the suction jar – a defective or cracked seal must be replaced.If the maximum vacuum and the tightness can not be reached, the device must not be operated and Technical Service must be informed.

Adjust the vacuum level
With the device running, clamp the patient tubing. Set the correct vacuum for the intended application by turning the vacuum control knob. Check the setting on the vacuum meter.

Check the suction jar and lid
Provided the suction jar and lid pass the tests before use, as described in sections 4.1 and 4.5, these can continue to be used and reprocessed. If the tests are not passed, the damaged parts must be disposed of in accordance with the regulations in the country of use and a new part used.

Before each use, check the suction jar and the lid of suction jar for cracks and brittle or faulty spots. The mechanical overflow safety device on the lid of suction jar must be assembled correctly and the float must be dry and free to move.
Damaged suction jars and lids must not be used, not even for the vacuum check described below!
Before each use, evacuate the suction jar several times up to the maximum vacuum. Damaged suction jars may implode under vacuum!

CLEANING

The device and accessories are not disinfected or sterile when delivered. For cleaning, disinfection or sterilization, the respective Operating Instructions and required cleaning regulations at the place of use must be observed.

Before cleaning, the device must be switched OFF and the mains power cable must be disconnected from the mains supply. Failure to comply may result in electric shock!
If the pump unit, and/or accessories such as the foot operated vacuum regulator are contaminated by failure to use the hydrophobic bacterial filter, by overflow or by another cause, the contaminated parts must be disposed of by the user in accordance with local regulations.
Do not use cleaning agents and disinfectants based on phenol!
If disregarded, there is a risk of destruction of the plastic materials by fine cracks.
Do not leave the disinfectant in the suction jar. The plastic material is thereby exposed to unnecessary chemical action and the strength of the suction jar may be affected.

Device housing

The surfaces should be cleaned with a damp cloth and a mild detergent.
After cleaning, dry the surfaces with a clean, dry cloth.
For disinfection, only use known agents that do not affect painted surfaces and plastic parts. For example: perform® sterile from Schülke. The recommendations of the disinfectant manufacturer regarding application and dosage must be followed.

Suction jar, lid of suction jar and silicone tubing
Ensure that the suction jar, lid and the silicone tubing are cleaned, disinfected and autoclaved together. This prevents any mix-up of the parts.

Remove the bottle from the fitting rail; dispose of bottle content in accordance with local regulations by twisting off the lid and turning the container upside down.
Autoclave to a maximum of 134°C for a maximum of 15 minutes.
Residues of disinfectants must be removed before autoclaving or neutralized.
Only autoclave dry parts.
Do not stack the parts when autoclaving.
Thermal disinfection: do not use alkaline detergents.
Chemical disinfection: With products that break down the chains of residues and, as a result, dissolve these residues.
Maximum permissible long-term temperature 140°C in steam and 150°C in dry heat.
Provided the functional check described in section 4.6 has been passed, the parts can be used and reprocessed.

Part description	Material
Suction jar	PSU Polysulfone
Lid with handle
Couplings connectors green and transparent
Couplings green and transparent
Pressure pin	Grivory® GVX 5H
Clamp with threaded pin	Grivory® GVX 5H
Pressure spring	stainless steel
4x O-ring 8.1 x 1.6mm	Silicone
O-ring silicone 12.42 x 1.78mm
Connection tubing and Patient tubing
Seal for lid of suction jar	EPDM Ethylene-Propylene-Diene (rubber)
Retainer for float of overflow safety device	POM Polyacetal (Polyoxymethylene)
Float for overflow safety device	PP Polypropylene

Remove any remaining liquid in the float of the overflow safety device before assembling the lid of suction jar. Remaining liquid in the vacuum flow may activate the hydrophobic bacterial filter.

MAINTENANCE

Maintenance work is described in the corresponding Service Instructions.
The device may only be serviced and repaired by appropriately trained technical personnel. The personnel must be familiar with the currently known risks and benefits of this device.

Maintenance interval

Ardo medical recommends carrying out maintenance once a year along with a precautionary technical safety check (STK) in accordance with EN 60601-1 or EN 62353, and/or UL 2601-1 or local regulations and having the process documented.

Service life, environment and disposal

When used according to the intended use, the service life of the device is 10 years, excluding consumables.
This equipment contains electric and electronic components. At the end of the device’s service life, the device must be disposed of in accordance with local regulations, or returned, cleaned and disinfected, to Ardo medical, or to any of the addresses listed under Warranty and Service for correct disposal.
The device is subject to the requirements of the WEEE directive.

Local regulations must be met for the disposal of potentially contaminated product components.

ACCESSORIES AND SPARE PARTS

Accessories

Part No.	Description
50.00.07	Foot operated vacuum regulator
50.00.57	Instrument tray for fitting rail
50.00.63	Pedal holder for foot operated vacuum regulator
50.00.99	Change-over valve including 3 connection tubings and clamp for fitting rail
50.00.170	Trolley with 4 castors, 2 of them antistatic with brake, inclusive fitting rail

Spare parts

Part No.	Description
50.00.01	Connection tubing with 2 angled coupling connectors, 0.5m
50.00.02	Patient tubing in silicone, transparent Ø 7/13mm with 1 angled coupling, 1.70m
50.00.04	Patient tubing in silicone, transparent Ø 10/18mm with 1 angled coupling, 1.70m
50.00.05	Hydrophobic bacterial filter
50.00.08	Lid with handle and mechanical overflow safety device, for patient tubing Ø 7mm
50.00.10	Lid with handle and mechanical overflow safety device, for patient tubing Ø 10mm
50.00.45	Silicone tubing, transparent, Ø 6/12mm, per meter
50.00.46	Silicone tubing, transparent, Ø 10/18mm, per meter
50.00.47	Silicone tubing, transparent, Ø 7/13mm, per meter
50.00.60	Coupling connector, transparent, Ø 5-8mm
50.00.61	Coupling connector, transparent, Ø 8mm
50.00.83	Retainer for float of overflow safety device
50.00.84	Float for overflow safety device
50.00.85	Coupling connector angled, green, Ø 8mm
50.00.86	Coupling connector angled, transparent, Ø 8mm
50.00.87	Coupling connector angled, transparent, Ø 13mm
50.00.167	1 liter suction jar, polysulfone, graduated
50.00.168	2 liter suction jar, polysulfone, graduated
50.00.169	5 liter suction jar, polysulfone, graduated
50.00.245	Foot switch for Master/Senator
50.00.246	Support for foot switch for Master/Senator, suitable for fitting rail
51.00.17	O-ring silicone Ø 14×2.0mm
99.00.303	O-ring silicone Ø 8.1×1.6mm, white
99.00.544	Seal for lid of suction jar

ELECTROMAGNETIC COMPATIBILITY (EMC)

Summary of test for Electromagnetic Compatibility

Further information about the EMC test can be found in the Service Instructions.
The test of electromagnetic compatibility according to IEC/EN 60601-1-2 for this device has shown that in the intended use no endangering of the functional safety or a failure of this device due to electromagnetic influences are expected.
This device uses HF-energy exclusively for its internal function.
Its HF-transmission is therefore very small, and it is therefore unlikely that adjacent electronic equipment will be affected. Since the propagation of electromagnetic variables is affected by absorptions and reflections from structures and/or by objects and people, the following must be observed:
This device should not be operated close to other devices.
Do not place any other devices on the housing of this device.
If it must operate close to other devices, the device should be observed to verify its intended performance.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
Mobile radio equipment or mobile phones should not be used close to this device or its mains power cable.
Interference may occur in the vicinity of equipment marked with the adjacent symbol.

WARRANTY AND SERVICE

Warranty
Unless otherwise stated, the warranty period for the suction pump Master or Senator is 5 years from the date of invoice.

General conditions
Ardo medical AG guarantees against material and manufacturing faults for products they have manufactured. Faulty material will be replaced at no cost during the warranty period, assuming there has been no improper usage. Excluded are consumables. To ensure the warranty and for the correct functioning of the device, the instructions in the Operating Instructions must be adhered to. Only accessories and spare parts from Ardo medical AG may be installed and/or utilized. Any right of warranty is waived if any changes are made by unauthorized persons or if changes are made which do not adhere to the applicable IEC/EN standards. There are no warranty claims that exceed the described scope of warranty, such as liability to consequential damages, etc.

Service
Please contact the following addresses for service, maintenance or any questions about this product:

Switzerland

Ardo medical AG Gewerbestrasse 19 CH-6314 Unteraegeri Switzerland
Tel. +41-(0)41 754 70 70
Fax +41-(0)41 754 70 71 info@ardo.ch
www.ardo.ch

Germany

Ardo medical GmbH Argelsrieder Feld 10 D-82234 Weßling Germany
Tel. +49 (0) 8153 / 90 877 0 Fax +49 (0) 8153 / 90 877 66 info@ardomedical.de
www.ardomedical.de

International

Authorized Importer

Manufacturer

Ardo medical AG Gewerbestrasse 19 CH-6314 Unterägeri Switzerland

Documents / Resources

ardo Master Suction Pump [pdf] Instruction Manual
Master Suction Pump, Master, Suction Pump, Pump

References

User Manual

ardo Master Suction Pump

Product specification