Master and Senator Operating Instructions June 2018

SUCTION TECHNOLOGY

99.03.822 06 / 2018

Suction Pump

Master and Senator

Operating Instructions

Copyright 2018 Ardo medical AG Gewerbestrasse 19 6314 Unteraegeri Switzerland T +41 (0)41 754 70 70 F +41 (0)41 754 70 71 [email protected] www.ardo.ch

TABLE OF CONTENTS 1. INTRODUCTION

3

1.1 General safety instructions

3

1.2 Precautions

3

2. APPLICATIONS

4

2.1 Intended use

4

2.2 Indication

4

2.3 Contraindication

4

3. PRODUCT DESCRIPTION

5

3.1 Overview of Master and Senator

5

3.2 Symbols on the device and their meaning

6

3.3 Hydrophobic Bacterial Filter

6

4. INITIAL OPERATION

7

4.1 Before Initial Operation

7

4.2 Connections on the Device and Accessories Device back side Device front side Lid of suction jar Change-over valve Instrument tray for fitting rail Foot operated vacuum regulator Foot switch

7 7 8 8 8 9 9 10

4.3 Lid of suction jar and suction jar

11

4.4 Trolley

12

4.5 Operation, switching ON the device Switching ON the device and operating with foot switch Operating state of mains switch and foot switch

13 13 14

4.6 Functional check

14

5. CLEANING

15

5.1 Device housing

15

5.2 Suction jar, lid of suction jar and silicone tubing

15

6. MAINTENANCE

16

6.1 Maintenance interval

16

6.2 Service life, environment and disposal

16

7. ACCESSORIES AND SPARE PARTS

17

8. ELECTROMAGNETIC COMPATIBILITY (EMC)

18

8.1 Summary of test for Electromagnetic Compatibility

9. TECHNICAL INFORMATION

19

9.1 Technical Data

19

12. WARRANTY AND SERVICE

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Operating Instructions Master and Senator Subject to modifications

1. 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. 1.1 General safety instructions -

-

The device is designed solely for the applications described in the Operating Instructions. Safe operation can only be guaranteed if original accessories and original spare parts from Ardo medical are used; hydrophobic bacterial filters, suction jars, tubes, 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.

1.2 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. 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. Protection against overheating of the device: Only operate the device with the rubber feet mounted on the housing; the air inlet for ventilation and the exhaust outlets are 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, make sure that the parking brakes are free before moving and that thresholds are crossed with caution.

Ardo medical AG

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Operating Instructions Master and Senator Subject to modifications

2. APPLICATIONS 2.1 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.

2.2 Indication 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 Liposuction 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.

2.3 Contraindication The device is not intended for: -

Cardiac surgery Operation with a low, precise vacuum, such as for Thorax drainage Domestic use Outdoor use and in means of transport

Ardo medical AG

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Operating Instructions Master and Senator Subject to modifications

3. PRODUCT DESCRIPTION 3.1 Overview of Master and Senator The suction power of Master corresponds to 50l/min, the suction power of Senator 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.

1

6

2 3

5

7

8

4

1

Carrying handle, integrated into the housing

2

Fitting rail

3

Mains switch ON / OFF

4

Hydrophobic Bacterial Filter

5

Control knob for vacuum regulation

6

Vacuum meter 0 to -100kPa / 0 to -700mmHg, Class 2.5

7

Fitting rail

8

Trolley with 4 castors, 2 of them antistatic with brake

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Operating Instructions Master and Senator Subject to modifications

3.2 Symbols on the device and their meaning

Follow the Operating Instructions Special notes in the Operating Instructions

0

Mains switch OFF

I

Mains switch ON Applied part Type BF (patient tubing) Rating label for device fuses Connector for Potential Equalization Connector for Foot Switch (optional) Orange LED indicates the operating state of the foot switch (optional) Control knob for vacuum regulation

IP21

2 = Protected against solid objects ≥ 12.5mm 1 = Protected against vertically falling water drops Manufacturer

3.3 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. 1 1

Filter housing

2

Hydrophobic filter material

2

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Operating Instructions Master and Senator Subject to modifications

4. INITIAL OPERATION 4.1 Before Initial Operation 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.

4.2 Connections on the Device and Accessories Device back side

1

2

1

Connector for foot switch (optional)

2

Connector for potential equalization

3

Device fuses

4

Connector for mains supply

3

4

Ardo medical AG

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Operating Instructions Master and Senator Subject to modifications

Device front side

1

Connector for hydrophobic bacterial filter

2

Connector for 0.5m connection tubing to suction jar

1

Connect the transparent angled coupling connector of the 0.5m connection tubing to the hydrophobic bacterial filter.

2

Connect the green angled coupling connector to the green male coupling on the lid of suction jar.

3

Connect the transparent angled coupling connector of the 1.7m patient tubing to the transparent male coupling on the lid of suction jar.

2

1

Lid of suction jar 1

2

3

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

A

1

B

4

1

To the vacuum connector of the vacuum pump

A

From the vacuum connector of the suction jar A

B

From the vacuum connector of the suction jar B

4

Change-over A to B

5

Clamp for fixing on a fitting rail

5

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Operating Instructions Master and Senator Subject to modifications

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

Foot operated vacuum regulator Foot operated vacuum regulator is 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.

1

1

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.)

2

Pedal holder for foot operated vacuum regulator (Optionally available holder for attaching the foot operated vacuum regulator to the trolley.)

2

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Operating Instructions Master and Senator Subject to modifications

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

1 1 2

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.)

2

Ardo medical AG

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Operating Instructions Master and Senator Subject to modifications

4.3 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.

1

2 3 4 5

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7 8

1

Pressure pin

2

Pressure spring

3

Lid with handle

4

4x O-ring 8.1 x 1.6mm

5

Coupling connectors green and transparent

6

Seal for lid of suction jar

7

O-ring silicone 12.42 x 1.78mm

8

Retainer for float of overflow safety device

9

Float for overflow safety device

10

Clamp with threaded pin

10

9

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

1

2

1

Lid with handle and mechanical overflow safety device

2

1 liter suction jar

3

2 liter suction jar

4

5 liter suction jar

3 4

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Operating Instructions Master and Senator Subject to modifications

4.4 Trolley Trolley is 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. 1 2 3 5

4

8 6

8'

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7 7

7

1

2x Hex socket flat countersunk head screw M5x10

2

1x Mounting plate

3

1x Fitting rail

4

2x Hex socket head cap screw M6x10

5

2x Protection plug

6

2x Hex socket head cap screw M6x40

7

2x Castor with brake, antistatic

8

2x Castor without brake

Ardo medical AG

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Operating Instructions Master and Senator Subject to modifications

4.5 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.

1

Mains switch ON / OFF

2

Control knob for vacuum regulation

1 2

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.

1

1

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

2

Foot switch in position OFF = LED orange lights up

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Operating Instructions Master and Senator Subject to modifications

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.

4.6 Functional check Check 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. Check suction jar and lid 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!

Ardo medical AG

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Operating Instructions Master and Senator Subject to modifications

5. 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 is contaminated by failure to use the hydrophobic bacterial filter or by another cause, the device 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. 5.1 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. The recommendations of the disinfectant manufacturer regarding application and dosage must be followed. 5.2 Suction jar, lid of suction jar and silicone tubing - 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 aldehyde-based disinfectants, e.g. Glutaraldehyde. - Maximum permissible long-term temperature 140°C in steam and 150°C in dry heat. Part description

Material

Suction jar Lid with handle Couplings connectors green and transparent

PSU Polysulfone

Couplings green and transparent Pressure pin Clamp with threaded pin Pressure spring

Grivory® GVX 5H stainless steel

4x O-ring 8.1 x 1.6mm O-ring silicone 12.42 x 1.78mm

Silicone

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.

Ardo medical AG

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Operating Instructions Master and Senator Subject to modifications

6. 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. 6.1 Maintenance interval Ardo medical recommends that maintenance and a precautionary safety check according to EN 60601-1 or to UL 2601-1 be performed and documented 1x per year. 6.2 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 applicable 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.

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Operating Instructions Master and Senator Subject to modifications

7. ACCESSORIES AND SPARE PARTS Accessories Part No.

Description

50.00.170

Trolley with 4 castors, 2 of them antistatic with brake, inclusive fitting rail

50.00.07

Foot operated vacuum regulator

50.00.63

Pedal holder for foot operated vacuum regulator,

50.00.245

Foot switch for Master / Senator

50.00.246

Support for foot switch for Master / Senator, suitable for fitting rail

50.00.99

Change-over valve including 3 connection tubings and clamp for fitting rail

50.00.57

Instrument tray for fitting rail

Spare parts Part No.

Description

50.00.05

Hydrophobic bacterial filter

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

50.00.60

Coupling connector, transparent, Ø 5-8mm

50.00.61

Coupling connector, transparent, Ø 8mm

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

50.00.45

Silicone tubing, transparent, Ø 6/12mm, per meter

50.00.47

Silicone tubing, transparent, Ø 7/13mm, per meter

50.00.46

Silicone tubing, transparent, Ø 10/18mm, per meter

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

99.00.544

Seal for lid of suction jar

50.00.83

Retainer for float of overflow safety device

50.00.84

Float for overflow safety device

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

99.00.303

O-ring silicone Ø 8.1x1.6mm, white

51.00.17

O-ring silicone Ø 14x2.0mm

Ardo medical AG

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Operating Instructions Master and Senator Subject to modifications

8. ELECTROMAGNETIC COMPATIBILITY (EMC) 8.1 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.

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Operating Instructions Master and Senator Subject to modifications

9. TECHNICAL INFORMATION 9.1 Technical Data Electrical data for 230VAC devices Mains supply voltage

230VAC

Mains frequency

50Hz

Power consumption

Master

140W / 0.6A

Senator

115W / 0.45A

Device fuse L/N

T1.25AH / AC250V

Electrical data for 115VAC devices Mains supply voltage

115VAC

Mains frequency

60Hz

Power consumption

Master

140W / 1.2A

Senator

115W / 1.0A

Device fuse L/N

T1.60AH / AC250V

Performance data Suction category Suction power max.

high vacuum / high flow Master

50l/min ±15%

Senator

30l/min ±15%

Vacuum meter

0 to -100kPa / 0 to -700mmHg / ±2.5%

Vacuum regulator

mechanically, continuously 0 to maximum

Vacuum height 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 MDD 93/42/EEC

IIa

Conformity for 230VAC devices Concerning Medical Device Directive MDD 93/42/EEC

0123

EN 60601-1 / EN60601-1-2 / EN60601-1-6 / 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 medical AG

E218915 UL2601-1 52YA

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Operating Instructions Master and Senator Subject to modifications