Transcript
Important information for medical device users
EQUIPMENT INFORMATION Covidien Genius 2 Thermometer Issue Covidien tested cleaning solutions for compatibility with the Genius 2 thermometer plastics and provided a list of recommended and non-approved cleaning/disinfecting solutions for the handset and base. Failure to use recommended cleaning agents may lead to excessive degradation of the thermometer plastic, making it brittle and susceptible to accelerated breakage and may invalidate warranty claims. Note: AHS IPC has determined that not all products in the vendor ‘recommended’ list are appropriate for this use, for example, Glutaraldehyde (Cidex™) is a highly toxic immersion-type high level disinfectant and Manuklenz™ is a cleanser, not a disinfectant; AHS IPC does not recommend their use. Alcohol 70% (with no other active ingredients) is the only cleaning/disinfection solution recommended by the manufacturer that is compatible with the handset, base, probe tip, and lens. Ref: 2016NOV15-E-COV
Action
2016 November 15 Device Correction
Information
Update
Other
ZONES/Sites Clinical Areas Affected
NORTH ZONE ALL Sites EDMONTON ZONE ALL Sites CENTRAL ZONE ALL Sites CALGARY ZONE ALL Sites SOUTH ZONE ALL Sites
Use cleaning/disinfectant recommended by the manufacturer and AHS IPC to clean and disinfect the handset and base after each patient use: 70% isopropyl alcohol wipes, with no other active ingredients – first choice, as they can be used on the handset, base, probe tip and lens. Other options: Caviwipe Classic or XL, and Virox products (e.g., OxivirTB) may be used on the handset and base, but not the probe tip or lens. Follow the vendor cleaning procedure (vendor notice, pp. 6-7, attached). Note: 30-minutes stabilization time is needed after cleaning the lens with 70% isopropyl alcohol. Recommended wipes for Genius 2 handset and base: Product Codes
Recommended Product Description
PREFERRED Options – Can be used for handset and base, as well as probe tip and lens: KC06070 Kimtech Wipe 70% Alcohol CN-PS-911EB Wipe Alcohol Sterile LP103-03 Alcohol Prep Pad
ALL Clinical Areas
Acceptable options – Can be used for handset & base; CANNOT be used for probe tip and lens: 11-1100, 11-1150 Caviwipe Classic or Caviwipe XL (“2009” formulation) 90-5144708 Wipe OXIVIRTB Disinfectant Cleaner (Note! Caviwipe1 and Caviwipe “2012” formulation are not recommended.) Complete and return the attached E&P Advisory Response form to
[email protected] or fax # (403) 955-9981. If you are not a user of this product, no response is required. Contact:
Scott Olsen, Provincial Lead - Clinical Engineering: Asset Management &Safety, AHS Phone: 780-735-0804
[email protected]
For AHS, Covenant Health, and subsidiaries’ use only. Do not distribute outside these organizations.
Covidien Medical Supplies Monitoring & OR Division Genius™ 2 Thermometer – Recommended Cleaning Agents
September 10, 2014
Attn: Genius™ 2 Thermometer Customers In a continued effort to provide optimal product support, the research and development team at Covidien has completed cleaning solution material testing relating to the Genius™ 2 thermometer. These chemicals have been tested on the Genius™ 2 thermometer to ensure compatibility with the plastics. The purpose of this correspondence is to highlight the chemicals that have proven to be suitable as well as chemicals that are not suitable for use on the Genius™ 2 thermometer. The recommended cleaning agents and non-approved cleaning agents are listed in the following tables (Note: This is not an exhaustive list). Failure to use recommended cleaning agents may lead to excessive degradation of the Genius™ 2 thermometer plastics, making the housing brittle and susceptible to accelerated breakage. Please be advised this may invalidate warranty repairs if damaged or broken Genius™ 2 thermometers have been exposed to non-approved cleaners. Plastic degradation is also seen with any chemicals containing ammonium. Should you have any further questions, please contact your local Covidien sales representative. Sincerely, Rachael Jones Product Manager, Thermometry
15 HAMPSHIRE STREET MANSFIELD, MA 02048
Covidien Medical Supplies Monitoring & OR Division Genius™ 2 Thermometer – Recommended Cleaning Agents
Recommended Cleaning Agents: Manufacturer Adams Healthcare Advanced Sterilization Products
Anios
Antec International Limited
Antiseptica chem. pharm. Produkte BD
Trade Name Sodium Hypochlorite Cidex™*
Salvanios™* PH7
Antec Virkon™*
KombiInstrumenten Desinfektion-N Toallitas de Alcohol
Bode
Bacillol™* 30
Bode Bode
Bacillol™* AF Bacillol™* Plus Bodedex™* Forte
Bode
Bode
Korsolex™* Extra
Bode
Mikrobac™*
Bode
Sterillium™*
Cleankill
Difficil-S™*
Clinitex Covidien
Clinitex™* R502 Webcol™
15 HAMPSHIRE STREET MANSFIELD, MA 02048
Active Ingredient
Concentration
Type
Pass/Fail
Sodium Hypochlorite
1%
Liquid
Pass
Glutaraldehyde
2.40%
Liquid
Pass
Liquid
Pass
Preparation 256 N.N-Didecyl-N-Methyl-Poly(Oxyethyl)Ammonium Proprionate Lauryldimethylamine Oxid Ethylenediamine Tetracetic Acid, Tetasodic Salt Ethylene Glycol Monopropylene Glycol Ethane-1.2-Diol.Momopolymere Polyhexamethylene Biguanide Hydrochloride Potassium Perooxomonsulphate Sodium Alkyl benzene Sulphonate Sulphamic Acid Malic Acid Sodium Polyphosphate Dipotassium Peroxodisulphate
50-52% 3-5% 4-6% 20-25% 20-25% <1.56%
Tablets
Pass
Formacetale, Glutaral
1%
Liquid
Pass
Wipes
Pass
Foam
Pass
Liquid Liquid
Pass Pass
Liquid
Pass
Liquid
Pass
Wipes
Pass
Liquid
Pass
Liquid
Pass
Wipes Wipes
Pass Pass
Isopropyl alcohol Ethanol Isopropyl Propan-1-ol propan-l-ol, Isopropyl, ethanol propan-l-ol, Isopropyl, glutaral Nonionic surfactant Amphoteric surfactant Ethyenedioxy dimethanol Glutaral Isopropanol Nonionic surfactant Nonionic surfactant Benzyl-C12-18-alkydimethylammoniumchlorides didecyldimethylammoniumchloride Benzyl-C12-18-alkydimethylammoniumchlorides didecyldimethylammoniumchloride Isopropyl propan-l-ol Mecetronium ethyl sulphate Troclosene Sodium, Dihydrate Sodium Chlorite Isopropanol Isopropyl alcohol
10-25% 5-10% 5-10%
5-10% 1-5% 10-25% 5-10% 5-10% 1-5% 1-5% <1% <1% <1% <1%
(>60%)
Covidien Medical Supplies Monitoring & OR Division Genius™ 2 Thermometer – Recommended Cleaning Agents Manufacturer
Trade Name
Ecolab
Actichlor™*
Ecolab
Incides™* N
Ecolab
Incidin™*
Gama Healthcare Gama Healthcare Glad Cleaning Systems Mediware Medlock Medical Metrex N/A N/A PDI PDI
Servisan
Synergy health Vernacare International Virox
Active Ingredient DICHLORO-1,3,5-TRIAZINETRIONE ADIPIC ACID Sodium Bicarbonate Isopropyl, Propan-1-ol Isopropyl Ethanol Benzalkoniumchlorid (BAC)
Clinell™* Propylene glycol Detergent Clinell™* Benzalkonium chloride Universal Propylene glycol Wet Wipe Oligo-[2-(2-ethoxy)-ethoxyethyl)-guanidinium-chloride} Disinfection Alkotip™* Isopropyl alcohol Sterets™* Isopropyl alcohol Caviwipes™* Product codes Isopropanol 11-1100 and (2009 Ethylene Glycol Monobutyl Ether 11-1150 Formulation) Bleach Sodium Hypochlorite 10-1 Solution Rubbing Alcohol Isopropyl Sani-Cloth™* Dimethyl Oxazolidine Detergent Iodopropynyl Butylcarbamate Super Sani™* multiple formulations Isopropyl Cloth with variable isopropyl Aqua Citrus dulcis Propylene gycol PEG-60 almond glycerides Detergent PEG-6 caprylic/capric glycerides C9/11 paret-8 phe-noxyethanol quaternary Ammonium compounds, Polymeric Azomax™* Biguanide and Bronopol
Concentration 45-55% 20-45% Not Listed
Type
Pass/Fail
Liquid
Pass
Wipes
Pass
Liquid
Pass
1-5%
Wipes
Pass
<1% 1-5%
Wipes
Pass
Wipes
Pass
Wipes Wipes
Pass Pass
10-20% 1-5%
Wipes
Pass
10% 70%
Liquid Liquid
Pass Pass
Wipes
Pass
Wipes
Pass
Wipes
Pass
Wipes
Pass
Tuffie™* 5
Cocoalkyl dimethylbenzyl Ammonium chloride
As Provided
Wipes
Pass
Virox™*
Hydrogen Peroxide
0.50%
Liquid
Pass
15 HAMPSHIRE STREET MANSFIELD, MA 02048
Covidien Medical Supplies Monitoring & OR Division Genius™ 2 Thermometer – Recommended Cleaning Agents
Non-Approved Cleaning Agents: Manufacturer
Trade Name
Anios
Anios D.D.S.H.™*
Anios
Surfanios™* Citron
Anios
Surfa'Safe™*
Antec (DuPont) Antec International Limited
Perasafe™*
Active Ingredient Quatenary Ammonium Propionate guanidinium acetate n-propanol N-(3-aminopropyl)-N-do-decylopropane-1,3-diamine didecyldimethyl-ammonium chloride Ca²+ and Mg²+ ions chelators Didecyldimethylammonium chloride polyhexa-methylene biguanide hydrochloride Sodium Perborate monohydrate
Perasafe™*
Sodium Perborate
Bode
Bacillol™*
Clinitex
Clinitex™* R512
Clinitex
Clinitex™* R513
Ebiox
Trionic™*
Ecolab
Diesin™* HG
Ecolab
Incides™* N
Ecolab
Sekulyse™*
Ecolab Gama Healthcare Gama Healthcare Glad Cleaning Systems
Sekusept™* Pulver Classic Clinell™* Sporicidal Clinell™* Alcoholic 2% Chlorhexidine Chlorine Disinection
Metrex
Caviwipes1™*
Metrex
Caviwipes™* (2012 Formulation)
Spray-Nine
Spray-Nine™*
Sanofi-Aventis
Phisohex™*
15 HAMPSHIRE STREET MANSFIELD, MA 02048
Propan-1-ol Isopropyl Ethanol <5% Non-Ionic Surfactants, DMDM Hydantoin, Iodopropynyl Butylcarbamate <5% Non-Ionic Surfactants, DMDM Hydantoin, Iodopropynyl Butylcarbamate Alkyl(C12-16)dimethylbenzylammonium chloride Polyhexamethylene Biguanide Hydrochloride Benzalkonium Chloride, Fattyalcohol Ethoxylaytes, Polyhexamethylene Biguanide Hydrochloride Biphenyl-2-ol Propan-2-ol Isopropyl Propan-1-ol Quatenary Ammonium benzyl-C12-16-alkyldimethyl alkylamineoxides propan2ol
Concentration 0-2.5% 0-2.5% 2.5-10%
25-45% 25-35% 1-5%
0.5 - 1% 0 - 0.5%
Sodium Perborate monohydrate & Carbonate
Type
Pass/Fail
Liquid
Fail
Liquid
Fail
Liquid
Fail
Liquid
Fail
Powder
Fail
Wipes
Fail
Wipes
Fail
Wipes
Fail
Wipes
Fail
Liquid
Fail
Foam
Fail
Liquid
Fail
Powder
Fail
Sodium carbonate peroxyhydrate Tetra acetyl ethylene diamine
25-50% 10-25%
Wipes
Fail
Isopropyl Chlorhexidine digluconate
50-75% 1-5%
Wipes
Fail
Active Chlorine Detergent Isopropanol Ethanol Ethylene Glycol Monobutyl Ether Didecyldimethylammonium chloride Isopropanol Ethylene Glycol Monobutyl Ether Diisobutylphenoxyethoxyethyldimethylbenzyl ammonium chloride Ethoxylated C9-C11 alcohols 2-Butoxyethanol Hexachlorophene
1000-1200 ppm 0.50% 15% 7.5% 1-5% 0.76% 17.2% 1-5% 0.28%
Wipes
Fail
Wipes
Fail
Wipes
Fail
Liquid
Fail
Liquid
Fail
1-3% 1-4% 3%
Covidien Medical Supplies Monitoring & OR Division Genius™ 2 Thermometer – Recommended Cleaning Agents Manufacturer
Trade Name
Hibiclens
Hibiclens™*
Steris
Vesta-Syde™*
Active Ingredient Chlorhedidine Gluconate Isopropyl Subtilisins Sodium Tetraborate Decahydrate Triethanolamine
Concentration 4% 4% <5% <5% <15%
Type
Pass/Fail
Liquid
Fail
Liquid
Fail
COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. ™* Trademark of its respective owner. Other brands are trademarks of a Covidien company.
15 HAMPSHIRE STREET MANSFIELD, MA 02048
Genius 2 Tympanic Thermometer and Base Cleaning and Disinfecting Instructions TM
Cleaning the Hand-set and Base: • Cover tip with clean probe cover - This will prevent harsh chemicals from damaging the tip and probe lens • The Genius 2 thermometer and base body may be wiped clean with a damp cloth or wipe. Added by AHS: • Squeeze the excess fluid from the wipe. If too wet, the chemical may NOTE: AHS IPC penetrate the handset and affect the thermometer functionality. recommends 70% • A 10:1 mixture of water and hypochlorite mixture, a damp isopropyl alcohol alcohol with no other ingredients, or wipe, Cidex™***, Manuklenz™*** or VIROX™* cleansing agents are Virox products or acceptable to clean the hand-set and base (excluding probe tip and lens). Caviwipe Classic; • Please refer to the list of recommended cleaning agents for additional cleaners. does NOT recommend Cidex or Manuklenz.
Cleaning the Probe Tip and Lens • For routine probe tip and lens cleaning, wipe with a lint-free cloth. • If the lens remains soiled, clean using a cloth dampened with warm water or an Isopropyl alcohol wipe.
• No other cleaner should come in contact with the probe tip and lens. • Remove all foreign matter from the thermometer tip. • Dry the lens at the end of the probe tip, using a lint‑free swab to remove the alcohol film or excess fluid. • The thermometer lens must be free from fingerprints and/or smudges for proper operation.
After cleaning the tip with alcohol, allow the thermometer to air dry for 30 minutes prior to use. Always remember: • Ensure your Genius™ 2 thermometer and base are clean, especially the probe tip lens.
• Check the lens prior to use. It should have a mirror‑like finish and be free from debris, fingerprints and smudges. A dirty lens will reduce the temperature reading.
• The Genius™ 2 thermometer is a non-sterile device. Do not use ethylene oxide gas, heat or autoclave to sterilize this thermometer. • Do not soak, rinse, spray or submerge the Genius 2 Tympanic thermometer and base.
* See reverse for cleaning and disinfecting quick guide
Genius 2 Tympanic Thermometer and Base Cleaning and Disinfecting Quick Guide TM
Cleaning the Hand-set and Base: 1
Cover tip with probe-cover.
Cleaning the Probe Tip and Lens (when needed) 2
1
Wipe with a lint-free cloth.
2
If the lens remains soiled: - Clean only with an Isopropyl alcohol wipe; - Dry lens with a lint-free swab; - Allow 30 minutes to dry.
* No other cleaner should come in contact with the probe tip and lens.
Wipe clean with damp cloth or wipe as per list of recommended cleaners.
NOTE: A dirty lens will reduce temperature reading accuracy.
A DAMAGED LENS FROM VIROX™*
* See reverse for full Cleaning and Disinfecting Instructions
A DIRTY LENS FROM EARWAX
CLEAN AND MIRROR-LIKE
COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. TM * Trademark of its respective owner. Other brands are Trademarks of a Covidien company. © 2016 Covidien. Currently licensed under Covidien LLC with Health Canada. Manufactured by: Covidien LLC, 15 Hampshire Street, Mansfield, MA, 02048 USA. CDN-M00003-E Rev. 2016/03
