PALAMIX Vacuum mixing system Instructions for Use PDF download

Vacuum mixing system with collection under vacuum

PALAMIX® EN

Instructions for use

4

(Revision status: 2020-11)

EN (US) Note: Instructions for use for sale within the US. Instructions for use

9

BG

Инструкции за употреба

14

CS

Návod k použití

19

DA

Brugsanvisning

24

DE

Gebrauchsanweisung

29

EL

Οδηγίες χρήσης

34

ES

Instrucciones de uso

39

ET

Kasutusjuhend

44

FI

Käyttöohje

49

FR

Notice d’utilisation

54

HR

Upute za uporabu

59

HU

Alkalmazási utasítás

64

IT

Istruzioni per l’uso

69

KK

Пайдалану нұсқаулары

74

KO

사용 설명서

79

LT

Naudojimo instrukcija

84

LV

Lietoöanas instrukcija

89

(Revision status: 2020-11)

10273 MM/JJ

(Дата на актуализиране на текста: 2020-11) (Poslední revise: 2020-11) (Aktualiseret: 2020-11) (Revisionsstand: 2020-11)

(Ημερομηνία αναθεώρησης: 2020-11) (Última revisión: 2020-11)

(Viimati muudetud: 2020-11) (Revisiostatus: 2020-11) (Date de révision: 2020-11) (Stanje revizije: 2020-11) (Aktualizálás időpontja: 2020-11) (Ultima revisione: 2020-11) (Редакция күйі: 2020-11) (2020년 11월 수정) (Tikrinta: 2020-11)

(Pārbaudes statuss: 2020-11) 2

EN

PALAMIX®

General information PALAMIX® is an orthopaedic vacuum mixing and application system for bone cements. PALAMIX® is available in two sizes: PALAMIX® uno and PALAMIX® duo and they are suitable for automatic collection of bone cement within the mixing cartridge under vacuum.

Intended User Healthcare professionals in a clinical context and experienced in the handling of the product. Warnings PALAMIX® uno and PALAMIX® duo are single-use devices and must never be re-used! Re-use may result in diminished safety, performance, and compliance with relevant specifications.

Components PALAMIX® uno (details for PALAMIX® duo in brackets) contains the following sterile components: • 1 (2) mixing cartridge, large enough to hold up to two (four) pouches of Heraeus Medical GmbH bone cement (uno: 2 x 40, duo: 4 x 40) • 1 (2) mixing rod with integrated mixing paddle and nozzle • 1 (1) funnel • 1 (1) vacuum hose • 1 (1) femoral pressuriser • 1 (1) knee pressuriser • 1 (2) short nozzle • 1 (2) spatula clip • 1 (1) work tray All components are not made with natural rubber latex and all components that come into contact with bone cement are not made with PVC.

Precautions Bone cement The sequence described in these instructions is optimized to suit Heraeus bone cements. If you are using bone cements from other manufacturers, please observe their specifications, the sequence for filling the vacuum mixing systems and their instructions for use. Regarding intended users Read these instructions for use before using for the first time and familiarize yourself with operation of the system. Test the bone cement properties and handling of PALAMIX® beforehand to account for your specific conditions. The bone cements should be extruded as soon as the surface of the bone cement is no longer sticky. The “finger test” should be carried out to check this. However, the bone cement must be extruded at the latest by the end of the temperature-dependent application time specified by the manufacturer (see corresponding instructions for use for the particular bone cement). During use, ensure that a suitable distance is left between non-sterile products and the sterile products PALAMIX® uno and PALAMIX® duo. The amount of bone cement dough required depends on the specific surgical intervention and on the technique being used. At least one additional set of PALAMIX® uno or PALAMIX® duo should be available before commencing the operation.

Intended purpose PALAMIX® is intended for in mixing bone cement with different viscosities under vacuum. Indications PALAMIX® is indicated for use in mixing bone cement with different viscosities under vacuum. Contraindications No contraindications for the use of PALAMIX® uno and PALAMIX® duo are known. Adverse events No adverse events for the use of PALAMIX® uno and PALAMIX® duo are known.

Supporting equipment Supporting equipment is required for the use of PALAMIX®:

Intended Patient Population Patients requiring bone cement application during surgery.

Product

Description

Quantity per sales unit

Article number

PALAMIX cement gun

Reusable application gun

1

66036163

PALAMIX® vacuum pump

Vacuum pump with non-return valve

1

66036748

PALAMIX® slim nozzle

For use with low-viscosity bone cements; ∅ 7 mm

10

66036747

PALAMIX® medium nozzle

Flexible, conical nozzle; ∅ 8.7 – 12.6 mm

10

66043960

®

Optional

The instructions for use of the supporting equipment must be followed. 4

Shelf life and sterilization Shelf life The shelf life of PALAMIX® uno or PALAMIX® duo is printed on the package. Do not use PALAMIX® uno or PALAMIX® duo if the date indicated has expired. Sterilization PALAMIX® uno and PALAMIX® duo have been sterilized using ethylene oxide. The product must not be resterilized. Storage PALAMIX® uno and PALAMIX® duo must be stored under dry and clean conditions. Care shall be exercised during transport and handling of PALAMIX® uno and PALAMIX® duo to avoid any damage or alteration to the performance characteristics and its packaging as received. Do not remove PALAMIX® uno or PALAMIX® duo from the sterile packaging until immediately before use. Do not use if packaging is damaged. Should you require further information, your Heraeus Medical GmbH partners would be pleased to assist you. Disposal Single components of PALAMIX® uno and PALAMIX® duo as well as packaging material must be disposed of as clinical waste in compliance with local regulations.

Product overview Quantity per sales unit

Article number

Vacuum mixing system with collection under vacuum

10

66057893

Vacuum mixing system with collection under vacuum, with two cartridges

10

66057897

Product

Description

PALAMIX® uno PALAMIX duo ®

5

Operating instructions

1.

1 2

1. Release the locking mechanism ( ). 2. Push the feed rod back to the stop.

2.

2 x “click” 1

3 2

3. 1

4.

6.

10 s

er wd -po MA PM

2

1. Close the handle on the mixing rod (2 x “click”!). 2. Connect the vacuum hose to the cartridge and PALAMIX® vacuum pump. 3. PALAMIX® is supplied with the locking screw opened. This setting must not be changed for the mixing process.

For filling, the cartridge must be positioned in tray station “1”. When using Heraeus Medical bone cements, the monomer liquid must be added first, followed by the bone cement powder.

DUO

DUO: Set the funnel aside in the sterile area.

Retract the mixing rod as far as the stop before locking the cap with the cartridge.

5.

Place the cap on the cartridge and screw on tightly until it stops, so that the ribs on the cap and the bars on the cartridge are aligned one above the other.

1

After closing the cartridge and before mixing, activate the PALAMIX® vacuum pump with your foot for 10 seconds. The vacuum generated can be seen in the cartridge.

6

2

7. 25 – 30 x

25 – 30 s

9. 1 2

DUO

Mix the bone cement by steadily moving the mixing rod up and down the entire length of the cartridge for at least 25 – 30 strokes (1 stroke per second).* During the entire mixing time activate the PALAMIX® vacuum pump.

8.

1. Hold the cartridge on the stem and insert it into tray station “2” without applying force. 2. Rotate the cartridge. When rotating, hold the stem of the cartridge, not the cap. The cartridge base is released and moves rapidly upward under vacuum. The bone cement is collected in the cartridge.

10.

DUO: Set the vacuum hose aside in the sterile area.

11.

1. Retract the mixing rod as far as the stop and 2. rotate briefly to the right/left.

1

2

1. Remove the vacuum hose. 2. Release the PALAMIX® vacuum pump footswitch.

1

2

1

2

* For exact mixing times, refer to the instructions for use of the bone cement manufacturer. 7

1. Release the handle, 2. retract the mixing rod and set it aside in the sterile area.

12.

3

2 1 “click”

1. Screw the cartridge onto the PALAMIX® cement gun with a quick rotational movement (“click”!). 2. Push the feed rod into the cartridge as far as it will go. 3. Secure the locking mechanism ( ).

13.

1

1. Tighten the locking screw on the nozzle beneath the predetermined breaking point. 2. Advance the bone cement up to the nozzle tip. If there is no adhesion, apply.

2

OPTIONAL

If activation under vacuum on the tray station is not possible, it can be generated manually. Two small tabs on the cartridge base must be pressed by hand. The cartridge base moves rapidly upward under vacuum. The bone cement is collected in the cartridge.

OPTIONAL

Break off the nozzle at the predetermined breaking point and remove the locking screw.

OPTIONAL

Expel the bone cement remaining in the nozzle with the aid of the mixing rod. Push on the femoral pressuriser, as necessary.

OPTIONAL

Screw on the short nozzle (e.g. for application in the knee), PALAMIX® medium nozzle (e.g. for minimal-invasive procedures) or PALAMIX® slim nozzle (for use with low-viscosity bone cements).

OPTIONAL

Short nozzle with knee pressuriser. Short nozzle with knee pressuriser and femoral pressuriser. Short nozzle with spatula clip.

8

EN (US)

PALAMIX®

Note: Instructions for use for sale within the US.

General information PALAMIX® is an orthopaedic vacuum mixing and application system for bone cements. PALAMIX® is available in two sizes: PALAMIX® uno and PALAMIX® duo and they are suitable for automatic collection of bone cement within the mixing cartridge under vacuum.

Intended User Healthcare professionals in a clinical context and experienced in the handling of the product. Warnings PALAMIX® uno and PALAMIX® duo are single-use devices and must never be re-used! Re-use may result in diminished safety, performance, and compliance with relevant specifications.

Components PALAMIX® uno (details for PALAMIX® duo in brackets) contains the following sterile components: • 1 (2) mixing cartridge, large enough to hold up to two (four) pouches of Heraeus Medical GmbH bone cement (uno: 2 x 40, duo: 4 x 40) • 1 (2) mixing rod with integrated mixing paddle and nozzle • 1 (1) funnel • 1 (1) vacuum hose • 1 (1) femoral pressuriser • 1 (1) knee pressuriser • 1 (2) short nozzle • 1 (2) spatula clip • 1 (1) work tray All components are not made with natural rubber latex and all components that come into contact with bone cement are not made with PVC.

Precautions Bone cement The sequence described in these instructions is optimized to suit Heraeus bone cements. If you are using bone cements from other manufacturers, please observe their specifications, the sequence for filling the vacuum mixing systems and their instructions for use. Regarding intended users Read these instructions for use before using for the first time and familiarize yourself with operation of the system. Test the bone cement properties and handling of PALAMIX® beforehand to account for your specific conditions. The bone cements should be extruded as soon as the surface of the bone cement is no longer sticky. The “finger test” should be carried out to check this. However, the bone cement must be extruded at the latest by the end of the temperature-dependent application time specified by the manufacturer (see corresponding instructions for use for the particular bone cement). During use, ensure that a suitable distance is left between non-sterile products and the sterile products PALAMIX® uno and PALAMIX® duo. The amount of bone cement dough required depends on the specific surgical intervention and on the technique being used. At least one additional set of PALAMIX® uno or PALAMIX® duo should be available before commencing the operation.

Intended purpose PALAMIX® is intended for in mixing bone cement with different viscosities under vacuum. Indications PALAMIX® is indicated for use in mixing bone cement with different viscosities under vacuum. Contraindications No contraindications for the use of PALAMIX® uno and PALAMIX® duo are known. Adverse events No adverse events for the use of PALAMIX® uno and PALAMIX® duo are known.

Supporting equipment Supporting equipment is required for the use of PALAMIX®:

Intended Patient Population Patients requiring bone cement application during surgery.

Product

Description

Quantity per sales unit

Article number

PALAMIX cement gun

Reusable application gun

1

66036163

PALAMIX® vacuum pump

Vacuum pump with non-return valve

1

66036748

PALAMIX® slim nozzle

For use with low-viscosity bone cements; ∅ 7 mm

10

66036747

PALAMIX® medium nozzle

Flexible, conical nozzle; ∅ 8.7 – 12.6 mm

10

66043960

®

Optional

The instructions for use of the supporting equipment must be followed. 9

Shelf life and sterilization Shelf life The shelf life of PALAMIX® uno or PALAMIX® duo is printed on the package. Do not use PALAMIX® uno or PALAMIX® duo if the date indicated has expired. Sterilization PALAMIX® uno and PALAMIX® duo have been sterilized using ethylene oxide. The product must not be resterilized. Storage PALAMIX® uno and PALAMIX® duo must be stored under dry and clean conditions. Care shall be exercised during transport and handling of PALAMIX® uno and PALAMIX® duo to avoid any damage or alteration to the performance characteristics and its packaging as received. Do not remove PALAMIX® uno or PALAMIX® duo from the sterile packaging until immediately before use. Do not use if packaging is damaged. Should you require further information, your Heraeus Medical GmbH partners would be pleased to assist you. Disposal Single components of PALAMIX® uno and PALAMIX® duo as well as packaging material must be disposed of as clinical waste in compliance with local regulations.

Product overview Quantity per sales unit

Article number

Vacuum mixing system with collection under vacuum

10

66057893

Vacuum mixing system with collection under vacuum, with two cartridges

10

66057897

Product

Description

PALAMIX® uno PALAMIX duo ®

10

Operating instructions

1.

1 2

1. Release the locking mechanism ( ). 2. Push the feed rod back to the stop.

2.

2 x “click” 1

3 2

3. 1

4.

6.

10 s

er wd -po MA PM

2

1. Close the handle on the mixing rod (2 x “click”!). 2. Connect the vacuum hose to the cartridge and PALAMIX® vacuum pump. 3. PALAMIX® is supplied with the locking screw opened. This setting must not be changed for the mixing process.

For filling, the cartridge must be positioned in tray station “1”. When using Heraeus Medical bone cements, the monomer liquid must be added first, followed by the bone cement powder.

DUO

DUO: Set the funnel aside in the sterile area.

Retract the mixing rod as far as the stop before locking the cap with the cartridge.

5.

Place the cap on the cartridge and screw on tightly until it stops, so that the ribs on the cap and the bars on the cartridge are aligned one above the other.

1

After closing the cartridge and before mixing, activate the PALAMIX® vacuum pump with your foot for 10 seconds. The vacuum generated can be seen in the cartridge.

11

2

7. 25 – 30 x

25 – 30 s

9. 1 2

DUO

Mix the bone cement by steadily moving the mixing rod up and down the entire length of the cartridge for at least 25 – 30 strokes (1 stroke per second).* During the entire mixing time activate the PALAMIX® vacuum pump.

8.

1. Hold the cartridge on the stem and insert it into tray station “2” without applying force. 2. Rotate the cartridge. When rotating, hold the stem of the cartridge, not the cap. The cartridge base is released and moves rapidly upward under vacuum. The bone cement is collected in the cartridge.

10.

DUO: Set the vacuum hose aside in the sterile area.

11.

1. Retract the mixing rod as far as the stop and 2. rotate briefly to the right/left.

1

2

1. Remove the vacuum hose. 2. Release the PALAMIX® vacuum pump footswitch.

1

2

1

2

* For exact mixing times, refer to the instructions for use of the bone cement manufacturer. 12

1. Release the handle, 2. retract the mixing rod and set it aside in the sterile area.

12.

3

2 1 “click”

1. Screw the cartridge onto the PALAMIX® cement gun with a quick rotational movement (“click”!). 2. Push the feed rod into the cartridge as far as it will go. 3. Secure the locking mechanism ( ).

13.

1

1. Tighten the locking screw on the nozzle beneath the predetermined breaking point. 2. Advance the bone cement up to the nozzle tip. If there is no adhesion, apply.

2

OPTIONAL

If activation under vacuum on the tray station is not possible, it can be generated manually. Two small tabs on the cartridge base must be pressed by hand. The cartridge base moves rapidly upward under vacuum. The bone cement is collected in the cartridge.

OPTIONAL

Break off the nozzle at the predetermined breaking point and remove the locking screw.

OPTIONAL

Expel the bone cement remaining in the nozzle with the aid of the mixing rod. Push on the femoral pressuriser, as necessary.

OPTIONAL

Screw on the short nozzle (e.g. for application in the knee), PALAMIX® medium nozzle (e.g. for minimal-invasive procedures) or PALAMIX® slim nozzle (for use with low-viscosity bone cements).

OPTIONAL

Short nozzle with knee pressuriser. Short nozzle with knee pressuriser and femoral pressuriser. Short nozzle with spatula clip.

13

SYMBOLS Manufacturer Sterilized using ethylene oxide Consult instructions for use Keep dry Do not re-use Do not resterilize Use-by date Batch code Catalogue number Do not use if package is damaged Federal law restricts this device to sale, distribution, and use by or on the order of a physician

155