PALAMIX
PALAMIX Cement Gun Instructions for Use
Instructions for Use
68 Pages
Preview
Page 1
Cement gun
CK
EN
PALAMIX® cement gun
Feed rod Feed rod release mechanism Attachment for mixing cartridge
Trigger grip Description The PALAMIX® cement gun is intended to accommodate the mixing cartridges of the PALAMIX® vacuum mixing system or the PALACOS® R+G pro and then to ensure precise and effortless application of bone cement.
The PALAMIX® cement gun should be cleaned and sterilised as for any conventional surgical instrument. Firstly clean off gross soiling from the product using a soft non-metallic brush. Loosen organic residues with ultrasonic treatment and then rinse under running water. To sterilise the PALAMIX® cement gun in the steam autoclave, sterilise according to the following processing guidelines.
The trigger of the PALAMIX® cement gun is operated by hand to expel the bone cement from the mixing cartridge. Activating the trigger advances the feed rod in the mixing cartridge and expels the bone cement under high pressure. The PALAMIX® cement gun can only be used in conjunction with the PALAMIX® vacuum mixing system or PALACOS® R+G pro. The respective operating steps are also described in detail as follows.
If the PALAMIX® cement gun has been sterilised with heat or steam, it must cool down before reuse. Maintenance Periodic maintenance of the cement gun is not required. Notes The PALAMIX® cement gun should only be used by trained personnel. The risk of hand injury or damage to protective gloves is possible due to improper handling. There is also a risk of damage to respective mixing cartridge if personel are not trained correctly.
Cleaning and sterilisation The PALAMIX® cement gun is intended for multiple use and must be cleaned and sterilised each time prior to use. The feed rod can be separated from the grip part of the PALAMIX® cement gun for ideal cleaning and sterilisation.
1
Check the functionality of the PALAMIX® cement gun prior to each operation. If damaged, contact your local Heraeus Medical representative. The user must ensure the correct use of the PALAMIX® cement gun.
To release, unlock the catch on the feed rod ( ) and remove the rod.
2
4
Processing guidelines according to EN ISO 17664 Instrument
PALAMIX® cement gun
Ref.
66036163
Manufacturer
Heraeus Medical GmbH Philipp-Reis-Str. 8/13 61273 Wehrheim, Germany www.heraeus-medical.com
Cleaning and Disinfection Instrument can be cleaned automatically
yes
Cleaning agent
alkaline
pH neutral
Neutralisation (optional)
phosphoric acid
citric acid
Thermal disinfection
at least 1 min., 90 °C
Ultrasonic cleaning (optional)
yes
Manual cleaning procedure
1. The feed rod must be separated from the grip part of the cement gun. 2. Firstly clean off gross soiling using a soft non-metallic brush (i. e. toothbrush) under running tap water (30 ± 5°C) for at least 90 seconds. 3. Loosen organic residues with 15 minutes of ultrasonic treatment. 4. By using a medium-hard toothbrush remove apparent soil especially at windings, sliding surfaces and other hardly accessible parts under running tap water (30 ± 5°C) for at least 60 seconds. At the same time move all mechanical elements to detach organic soil and check visually that the parts of the cement gun are absolutely clean. 5. While rinsing pay particular attention to flushing the inner areas. 6. Wipe down feed rod and the grip part using a lint free cloth.
Sterilisation The instrument must be sterilised?
yes
Minimum 6 minutes, gravity – no pre-vacuum (SAL 10-6)
steam
134°C
Minimum 3 minutes, three pre-vacuum cycles (SAL 10-6)
steam
134°C
Components made of stainless steel, handle as instruments, medical device class I. Bearings to be oiled.
5
CK
EN (US)
PALAMIX® cement gun
Note: Instructions for use for sale within the US.
Feed rod Feed rod release mechanism Attachment for mixing cartridge
Trigger grip Description The PALAMIX® cement gun is intended to accommodate the mixing cartridges of the PALAMIX® vacuum mixing system or the PALACOS® R+G pro and then to ensure precise and effortless application of bone cement.
The PALAMIX® cement gun should be cleaned and sterilised as for any conventional surgical instrument. Firstly clean off gross soiling from the product using a soft non-metallic brush. Loosen organic residues with ultrasonic treatment and then rinse under running water. To sterilise the PALAMIX® cement gun in the steam autoclave, sterilise according to the following processing guidelines.
The trigger of the PALAMIX® cement gun is operated by hand to expel the bone cement from the mixing cartridge. Activating the trigger advances the feed rod in the mixing cartridge and expels the bone cement under high pressure. The PALAMIX® cement gun can only be used in conjunction with the PALAMIX® vacuum mixing system or PALACOS® R+G pro. The respective operating steps are also described in detail as follows.
Warnings If the PALAMIX® cement gun has been sterilised with heat or steam, it must cool down before reuse. The PALAMIX® cement gun should only be used by trained personnel. The risk of hand injury or damage to protective gloves is possible due to improper handling. There is also a risk of damage to respective mixing cartridge if personnel are not trained correctly.
Cleaning and sterilisation The PALAMIX® cement gun is intended for multiple use and must be cleaned and sterilised each time prior to use.
Maintenance Periodic maintenance of the cement gun is not required.
The feed rod can be separated from the grip part of the PALAMIX® cement gun for ideal cleaning and sterilisation.
1
Precautions Check the functionality of the PALAMIX® cement gun prior to each operation. If damaged, contact your local Heraeus Medical representative. The user must ensure the correct use of the PALAMIX® cement gun.
To release, unlock the catch on the feed rod ( ) and remove the rod.
Caution Federal law restricts this device to sale, distribution, and use by or on the order of a physician.
2
6
Processing guidelines according to EN ISO 17664 Instrument
PALAMIX® cement gun
Ref.
66036163
Manufacturer
Heraeus Medical GmbH Philipp-Reis-Str. 8/13 61273 Wehrheim, Germany www.heraeus-medical.com
Cleaning and Disinfection Instrument can be cleaned automatically
yes
Cleaning agent
alkaline
pH neutral
Neutralisation (optional)
phosphoric acid
citric acid
Thermal disinfection
at least 1 min., 90 °C
Ultrasonic cleaning (optional)
yes
Manual cleaning procedure
1. The feed rod must be separated from the grip part of the cement gun. 2. Firstly clean off gross soiling using a soft non-metallic brush (i. e. toothbrush) under running tap water (30 ± 5°C) for at least 90 seconds. 3. Loosen organic residues with 15 minutes of ultrasonic treatment. 4. By using a medium-hard toothbrush remove apparent soil especially at windings, sliding surfaces and other hardly accessible parts under running tap water (30 ± 5°C) for at least 60 seconds. At the same time move all mechanical elements to detach organic soil and check visually that the parts of the cement gun are absolutely clean. 5. While rinsing pay particular attention to flushing the inner areas. 6. Wipe down feed rod and the grip part using a lint free cloth.
Sterilisation The instrument must be sterilised?
yes
Minimum 6 minutes, gravity – no pre-vacuum (SAL 10-6)
steam
134°C
Minimum 3 minutes, three pre-vacuum cycles (SAL 10-6)
steam
134°C
Components made of stainless steel, handle as instruments, medical device class I. Bearings to be oiled.
7
SYMBOLS Manufacturer Catalogue number Consult instructions for use Serial number Federal law restricts this device to sale, distribution, and use by or on the order of a physician
67
Heraeus Medical GmbH Philipp-Reis-Straße 8/13 61273 Wehrheim, Germany www.heraeus-medical.com PALAMIX® is a trademark of Heraeus Medical GmbH. Made in Germany.