HF-GB-17664, Rev. D | Page 1 / 8 Status: 07/2023 HF-GB-17664, Rev. D | Page 1 / 8 Status: 07/2023
Reprocessing of Hu-Friedy Dental Hand Instruments and Accessories
1.0 Fundamental Points All non-sterile instruments are to be cleaned, disinfected, and sterilized prior to each use, and also prior to first use.
The person responsible for reprocessing (i.e. the operator) is responsible for proper instrument reprocessing using onsite equipment and safe procedures that are validated for cleaning, disinfection, and sterilization. The sterilization equipment must also be maintained and checked per the manufacturer’s recommendation as well as the validated parameters applied to each cleaning and sterilization cycle. Additionally, consider the legal provisions valid for your country as well as to the hygienic instructions of the doctor´s practice or hospital. Use only freshly prepared detergent solutions, as well as only low contaminated and deionized water (maximum 10 cfu/ml) as well as low endotoxin contaminated water (maximum 0.25 endotoxin units/ml), i.e. aqua purificata (highly purified water acc. Pharmacopeia), and HEPA-filtered air for drying, respectively. Water quality may influence the result of the cleaning and disinfection of the instruments. Corrosion could be caused by high contents of chloride or other minerals in the tap water. If problems with stains and corrosion occur and other reasons can be excluded, it might be necessary to test the tap water quality in your area. With the use of completely deionized or distilled water most water quality problems can be avoided beforehand. Within the EU, all used and contaminated Instruments must be handled with protective gloves fulfilling the requirements of regulation (EU) 2016/425. Hu-Friedy provides such protective gloves (Partcodes: Size 7 = 40-060; Size 8 = 40-062; Size 9 = 40-064; Size 10 = 40-066). Contaminated Instruments must be disinfected as early as possible in the reprocessing process, in order to maximize safety for staff members when handling contaminated instruments. Using an instrument management system like the Hu-Friedy IMS System gives you considerable benefits. It is the ideal solution for arranging your instruments in an organized manner, cleaning, disinfecting, sterilizing and storing in an efficient way, providing maximum security.
In case of a serious incident that has occurred in relation to our devices within the European Union, please report by either calling Hu-Friedy for assistance Tel 00800 4837 4339 or send an e-mail to info@hu-friedy.eu. In addition, please inform your national competent authority.
2.0 Instrument Cassettes – Hu-Friedy Instrument Management System (IMS) IMS is an established and well-thought-out system, which gives you considerable benefits. It is the ideal solution for arranging your instruments in an organized manner, pre-cleaning, cleaning, sterilizing, and storing in an efficient way, providing maximum security.
3.0 Instrument Reprocessing Steps After receiving a new instrument, make sure you follow the initial cleaning, disinfection and sterilization steps before using it for the first time. This step is essential for the patient’s health. If possible, an automatic procedure in a Washer / Disinfector unit should be used for cleaning and disinfection of the instruments. A manual procedure – even in case of application of an ultrasonic bath – should only be used if an automatic procedure is not available or if such a method is not compatible with specific materials; in this case, the significantly lower efficiency of a manual procedure must be considered. The pre-treatment has to be performed in both cases. All assembled instruments must be disassembled before reprocessing (for further details, please see 9.0 Special Procedures section). Effective cleaning and disinfection are an indispensable requirement for proper instrument sterilization. 3.1 Pre-Treatment Before processing the instruments, remove coarse impurities on the instruments immediately after application and pre-treatment within one hour from the application. In case the instruments are transported to an external service provider, ensure the instruments remain soaked to avoid fixation of proteins e.g. by using a pre-cleaning product such as Enzymax Spray Gel (IMS-1229). Use an enzymatic cleaner, e.g. Hu-Friedy Enzymax (Partcodes: Enzymax Liquid: IMS-1222, IMS-1226, or a disinfectant solution during pre-soaking. The disinfectant should… - be free of aldehydes to prevent fixation of blood impurities, - possess a fundamentally approved efficiency (i.e. DGHM, RKI approval or CE marking), - be suitable for the disinfection of medical devices and - be compatible with the instruments (see 7.0 Material resistance section and 9.0 Special Procedures section).
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Consider, that the disinfectant used in the pre-treatment step serves only for personal safety and cannot replace the disinfection step, which should be performed later. Only use soft brushes such as Art. No. 1003414000 (Schellenberger), Art. No. MED100.33, MED100.43, MED100.18, or MED100.17 (Insitumed). PROCEDURE: Completely disassemble the instruments, if applicable. Pre-soak the devices for at least 5 minutes* and make sure that all surfaces are wetted and lumens are filled with water. Brush the instruments to remove residues from the surface, paying special attention to lumens and dead ends. Also make sure that movable parts are brushed in open and closed position. Difficult to reach positions such as hinges, mating surfaces, lumens or dead ends shall be flushed at least 3 times with minimum 50 ml cold deionized water, using a syringe or a rinsing adapter.*
* These parameters are validated for Enzymax Liquid. For other cleaning agents and disinfectants, the instructions of the manufacturer must be observed.
3.2 Cleaning and Disinfection
3.2.1 Automatic Cleaning and Disinfection in a Washer-Disinfector Unit When using a Washer-Disinfector unit, make sure that… - the efficiency is fundamentally approved (e.g. EN ISO 15883, DGHM approval, CE marking), - your process is validated, including equipment, detergents, temperatures, durations and loading, and - regular maintenance and inspection/calibration is done. For the selection of detergents to be used with the Washer-Disinfector unit, consider the following items: - Fundamental suitability for cleaning of medical devices - Compatibility with the instrument materials (see 7.0 Material resistance section and 9.0 Special Procedures section) - Detergent manufacturer instructions regarding concentration and soaking time
PROCEDURE: Connect devices with lumen to flush ports in the washer-disinfector. Load the washer-disinfector as validated. Start the validated program. Remove the instruments after end of program. Let the instruments dry. Conduct post-disinfection steps (see section 4.0)
The fundamental suitability of the instruments for an effective automatic cleaning and disinfection was demonstrated by an independent accredited test laboratory under the following conditions: Washer-Disinfector Miele Professional G 7836 CD Racks Mobile injector unit (Miele) E429, Four-level rack (Miele) E 493 Cleaning Cycle • 2 minute pre-cleaning with cold tap water • Draining • 5 minute cleaning with 55 °C cleaning solution • Draining • 3 minute rinsing with cold deionized water • Draining • 2 minute rinsing with cold deionized water • Draining Cleaning Solution 0.5 % cleaning solution neodisher® Mediclean Dental (Chemische Fabrik Dr. Weigert, Hamburg) Validation Report Project Number: 00418-1 Examination of an Automated Cleaning Process using quantitative Detection of Protein and Hemoglobin and the Radionuclide Method
The responsibility for reprocessing of Hu-Friedy instruments according to parameters which are not specified in this document lies with the customer.
3.2.2 Manual and Ultrasonic Cleaning and Disinfection For the selection of detergents to be used for manual cleaning and disinfection, consider the following items: - Fundamental suitability for cleaning of medical devices. - Approved efficiency (e.g. VAH/DGHM, RKI approval or CE marking). - Compatibility with the instrument materials (see 7.0 Material resistance section and 9.0 Special Procedures section). - Detergent manufacturer instructions regarding concentration, temperature and soaking time
Combined cleaning/disinfection solutions should be used only in the case of extremely low contamination (no visible impurities), unless indicated explicitly otherwise by the manufacturer of the combined detergent/disinfectant.
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CLEANING PROCEDURE: Place the devices in an ultrasonic bath containing a cleaning solution at min. 45°C for at least 15 minutes*. At the beginning of the soak time flush the lumens with 5 ml of the cleaning solution using a syringe. Non-rigid components shall be operated during the immersion. Difficult to reach positions such as hinges, mating surfaces, lumens or dead ends shall be flushed at least 3 times with minimum 50 ml cold deionized water, using a syringe or a rinsing adapter.* Remove the instruments from the cleaning solution. Rinse the instruments under running water for at least 1 minute. Inspect optically for proper cleaning.
* These parameters are validated for Enzymax Liquid. For other cleaning agents and disinfectants, the instructions of the manufacturer must be observed.
DISINFECTION PROCEDURE: Soak the devices in the disinfectant solution for the duration intended by the disinfectant manufacturer. Make sure they are completely immersed. Difficult to reach positions such as hinges, mating surfaces, lumens or dead ends shall be flushed with the disinfectant, using a syringe or a rinsing adapter. Non-rigid components shall be operated during the immersion Remove the instruments from the disinfectant. Rinse the instruments under deionized water for at least 1 minute*. Let the instruments dry. Conduct post- disinfection steps (see sections 4.0)
* These parameters are validated (Validation Report: 10918-1)
The fundamental suitability of the instruments for an effective automatic cleaning and disinfection was demonstrated by an independent accredited test laboratory under the following conditions:
Cleaning Solution
0.8 % Enzymax Liquid (Hu-Friedy Mfg. Co., LLC, USA)
Validation Report
Project Number: 00418-2 Examination of a Manual Cleaning Process using quantitative Detection of Protein and Hemoglobin and the Radionuclide Method
The responsibility for reprocessing of Hu-Friedy instruments according to parameters which are not specified in this document lies with the customer.
4.0 Post- Disinfection Steps
4.1 Inspection and Maintenance If there are still contamination attached to the instruments, clean and disinfect again.
Inspect all instruments after the cleaning and disinfection step for corrosion and damaged surfaces, Light corrosion on the surface can be removed with Shine reNew (IMS-1455). If the corrosion cannot be completely eliminated, the instruments should be removed from use. Otherwise such corrosion could damage other instruments. After treating an instrument with Shine reNew, the instrument must be cleaned and sterilized once more. Keep in mind that instruments shall no longer be reused in case the labelling is fading.
Re-sharpen instruments if necessary. Afterwards, completely remove any residues, such as metal residue or sharpening oil. Assemble disassembled instruments if necessary (see 9.0 Special Procedures section).
Hinged instruments have to be lubricated with a lubricant suitable for steam sterilization, like Hu-Friedy Instrument Lubricant Spray (ILS).
4.2 Packaging All instruments must be completely dry before packaging. Then, package immediately.
We recommend the use of a cassette system, like the Hu-Friedy IMS System and Hu-Friedy Bagettes (pouches), Hu-Friedy Sterilization wrap (Hu-Friedy IMS-1210M, IMS-1211M, IMS-1212M), Hu-Friedy Bonded Double Wraps (IMS-2215, IMS-2220, or IMS-2224) or suitable sterilization containers, if the following requirements are fulfilled: - Conformity with EN ISO/ANSI AAMI ISO 11607-1 and 2 and applicable parts of EN 868 - suitable for steam sterilization (temperature resistance up to at least 141 °C (286 °F), sufficient steam permeability) - sufficient protection of the instruments and the sterilization packaging against mechanical damage - regular maintenance according to the manufacturer’s instructions (Sterilization Containers: limitations also see 9.0 Special Procedures section)
5.0 Sterilization Please use only the recommended sterilization procedures listed below. Other sterilization procedures are the responsibility of the user.
Restrictions: The flash sterilization procedure must not be used! Do not use radiation sterilization, formaldehyde sterilization, ethylene oxide sterilization, or plasma sterilization!
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The application of dry heat sterilization is the responsibility of the user. For some products the dry heat sterilization procedure has been explicitly excluded (Please see 9.0 Special Procedures section). 5.1 Steam Sterilization
For sterilizing, please remember the following: -
maximum sterilization temperature of 138 °C (280 °F) Minimum exposure time to sterilization temperature: - 20 minutes at 121 °C (250 °F) or - 5 minutes at 132 °C (270 °F)/ - 4 minutes at 134 °C (273 °F)
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- The manufacturer’s instructions with respect to routine inspection and the regular maintenance of the Sterilizer must be observed. - The sterilizer must be maintained per manufacturer’s recommendation. - Only low contaminated and deionized water (i.e. aqua purificata) should be used. - The sterilized items have to be completely dried after sterilization and before handling. Sterilizers with an automatic drying program are recommended.
STERILIZATION PROCEDURE: Use properly installed and validated sterilizers, following instructions of the manufacturer. Load sterilizer as recommended by the manufacturer. Run validated program.
The fundamental suitability of the instruments for an effective sterilization was demonstrated by an independent accredited test laboratory under the following conditions:
Sterilization Method
Pre-vacuum Mode
Sterilizer
W & H Lisa MB 17 Steam Sterilizer
Sterilization Temperature
134 °C (273°F)
Pre-Vacuum Phases
3
Holding (full cycle)
4 minutes
Drying Time
30 minutes*
Validation Report
Project Numbers: 25517-1; 25517-2 Validation of a Sterilization Process using Steam Sterilization in Pre-vacuum Mode Method MD 4.0: Sterilization validation of medical products with moist heat
Project Numbers: 10918-1; 10918-2 Determination of Residual Moisture after Sterilization using Steam Sterilization in Pre-vacuum Mode
The responsibility for reprocessing of Hu-Friedy instruments according to parameters which are not specified in this document lies with the customer.
6.0 Transport and Storage of Reprocessed Instruments Please store the instruments after sterilization in a dry and dust free place.
Sterilization can only be maintained, if the instruments remain packaged or wrapped - impermeable to micro-organisms - following validated standards. The status of the sterilization has to be clearly indicated on the wrapped packages or the containers. In case the reprocessed instrument is transported, make sure to use air-conditioned vehicles in order to avoid condensate formation. For safety reasons, keep sterile and non-sterile instruments strictly apart.
7.0 Material resistance We recommend not to use detergents such as strong alkalines (> pH 9), strong acids (< pH 4) phenols or iodophors, interhalogenic agents/halogenic hydrocarbons/iodophors, strong oxidizing agents/peroxides and organic solvents.
Do not clean any instruments, sterilization trays or sterilization containers using metal brushes or steel wool!
Do not expose any instruments, cassettes, trays or sterilization containers to temperatures higher than 141 °C (286 °F)! Exposure to higher temperatures is the responsibility of the user.
Please also consider the information under the 9.0 Special Procedures section.
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8.0 Reusability and Single Use 8.1 Reusability
The user is responsible for inspecting instruments prior to each use, and for the use of damaged and dirty instruments. The instruments can be reused, unless indicated otherwise (see 9.0 Special Procedures section). The lifetime of instruments depends on the frequency of use, the care by the user and proper reprocessing methods. Please contact your local Hu-Friedy agent with questions about the expected life of any Hu-Friedy product.
8.2 Single Use Single use instruments are intended and manufactured for one use only.
9.0 Special Procedures for Specific Hu-Friedy Instruments Aluminium Instruments Cleaning / Disinfection: -
Use neutral cleaning agents and disinfectants suitable for Aluminium. - Check cleaning agent label for precautions for use with Aluminium. - Do not clean in an ultrasonic cleaner. - Clean by hand or in a Washer-Disinfector unit.
Processing: Note: Anodized aluminium instruments, when processed with Stainless Steel instruments may cause an adverse chemical reaction.
Carbon Steel Instruments
Processing: -
Clean, disinfect and sterilize separately.
- Do not clean, disinfect or sterilize with other stainless-steel instruments. - Do not clean / disinfect in a Washer-Disinfector unit.
Hinged Instruments
Processing: - Process in an open state and lubricate using Instrument Lubricant Spray (ILS) prior to sterilization.
Oversized Instruments
Note: If instruments do not fit in cassettes, other systems should be considered for reprocessing. Please call Hu-Friedy for assistance Tel 00800 4837 4339 or send an e-mail to info@hu-friedy.eu.
Aspirators and Aspirator Tips
Processing: - Clean, disinfect and sterilize only in a completely disassembled state.
Cleaning / Disinfection: -
For automated cleaning and disinfection in a Washer-Disinfector unit connecting rinsing adapters must be used, if the inserts are processed inside a cassette system. Otherwise open tray systems for automated cleaning and disinfection or manual cleaning and disinfection is recommended ( no Ultrasonic cleaning and disinfection! ).
Chu’s Aesthetic Tool Kit Tips
Note: The tip will last for approximately 5 reprocessing cycles.
Processing: - Clean, disinfect and sterilize with tip and handle disassembled. - Tips with fading markings should be replaced. - Do not disinfect with phenols or iodophors. - Do not use dry heat.
Colorvue-Tips
Note: The tip shall be disposed after a maximum of 30 reprocessing cycles.
Processing: - Clean, disinfect and sterilize with tip and handle disassembled. - Tips with a fading black marking should be replaced. - Do not disinfect with phenols or iodophors. - Do not use dry heat or rapid heat sterilization.
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Composite Brush Handle
Processing: - Clean, disinfect and sterilize in a completely disassembled state.
Container for Sterilization and Accessories
Processing: - For reprocessing, the lid of the Container and the filter holding devices in the base and the lid must be removed. - If single use paper filters have been used, they must be removed before reprocessing. Indica- tors must be removed from the label holding device. Cleaning / Disinfection: - For the cleaning and disinfection of anodized Aluminium Sterilization Containers only deter- gents and disinfectants can be used which are approved for this material. - For the reprocessing in a Washer-Disinfector unit the components of the Container have to be placed securely in the washing baskets. Spraying nozzles and arms should not be blocked. Do not use acid neutralizers for the reprocessing of Aluminium Containers. - Container made of Aluminium cannot be cleaned or disinfected in an Ultrasonic Cleaner Unit. - Container-Cassettes may be cleaned and disinfected with all procedures recommended for IMS-cassettes. - Permanent Filters of Teflon may be cleaned and disinfected in a Washer-Disinfector unit. - Wrapping Drapes for aseptic removal must be cleaned with the standard procedures for clinical or dental office textiles, before reuse. Do not starch wrapping drapes
Sterilization: -
Sterilization Containers made of anodized Aluminium have been developed especially for ster- ilization in Steam Sterilizers with pre-vacuum, fractioned vacuum or fractioned flow processes. Hu-Friedy Sterilization Containers cannot be used for other sterilization methods.
Maintenance: - The surface of Aluminium Containers is very sensitive in respect to mechanical impact. For this reason, do not use metal brushes or scouring agents. - For the removal of stains, residues of inscriptions or adhesive tapes only a commercial cleaner for anodized Aluminium may be used (no benzine or acetone!) After such treatment the Containers must be cleaned once more.
Crown Remover (CRL, CRU)
Processing: - Clean, disinfect and sterilize in a completely disassembled state.
Cleaning / Disinfection: -
Do not disinfect with phenols or iodophors.
Sterilization: -
Do not sterilize with dry heat.
IMPLACARE
Sterilization: - IMPLACARE disposable resin tips can be steam sterilized prior to use. - They are intended for one use only! - Clean, disinfect and sterilize in a completely disassembled state.
Mallet
Processing: - Clean, disinfect and sterilize in a completely disassembled state.
Mouth Gags (MGA, MGC, MGI)
Processing: -
When using a cassette system for cleaning/sterilization, the opening where the nylon tubing slips over the instrument tip must not be covered so as to allow the tips to properly drain. Clean, disinfect and sterilize in a completely disassembled state.
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Mouth Mirrors
Processing: - To avoid scratches on the mirror surface from other pointed instruments, reprocess in an instrument cassette with instrument rails. - Clean, disinfect and sterilize in a completely disassembled state. Cleaning / Disinfection: Note: All types of Rhodium coated Mouth Mirrors should not be cleaned and disinfected in an ultrasonic cleaner.
O-Rings
Sterilization: -
O-Rings cannot be dry heat sterilized
Osteotomes and Osteotome Handles
Processing: Clean, disinfect and sterilize in a completely disassembled state if applicable.
Plastic Filling Instruments
Processing: - Process in cassettes or trays with instrument rails to avoid scratches on the surface from other pointed instruments. Maintenance: - Residues of Filling Materials and etching products must be removed immediately. - Plastic Filling Instruments are designed with an extra smooth surface, in order to provide a better handling with composite materials. Scratches that are not visible might cause composite materials to stick to the rougher surface. Cleaning / Disinfection: - For resin or silicone products do not use detergents or disinfectants containing phenols or iodophors. Sterilization: - Dry Heat is explicitly not compatible with Instruments with resin handles (handle #8), with resin or Silicone components, inserts on any instruments, or with resin cassettes.
Resin Instruments, Resin Components or Resin Cassettes
Retractors, Metal
Processing: - Removable retractor tips must be disassembled from the handle before cleaning/disinfection and sterilization.
Retractors, Plastic (CRPC, CRPA)
Cleaning / Disinfection: - Can only be disinfected by chemical disinfection. Do not clean / disinfect in a Washer- Disinfector unit.
Sterilization: -
Do not sterilize (steam, dry heat etc.)!
Root Canal Instruments
Processing: - Reprocess in suitable endodontic stands (i.e. Hu-Friedy IMS-1275).
Cleaning / Disinfection: - Pre-treatment should be conducted outside the Endodontic stand. - Automated cleaning and disinfection in a Washer-Disinfector unit is recommended. - Ultrasonic cleaning in the Endodontic stand is not recommended.
Scalpel Handles
Processing: - Clean, disinfect and sterilize in a completely disassembled state.
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Scaler marked with Color Coding Rings (IMS-1280L, IMS-1286L, IMS-1281, IMS-1287, IMS-12810, IMS-1287L, IMS- 12810L, IMS-1288, IMS-12811, IMS- 1288L, IMS-12811L, IMS-1289, IMS-1281L, IMS- 1289L, IMS-1282, IMS-1282L, IMS-1283, IMS-1283L, IMS-1284, IMSö1284L, IMS- 1234, IMS-1285, IMS-1285L, IMS-1280, IMS-1286)
Processing: - For reprocessing, attached Color Coding Rings do not have to be removed
Validation reports: -
Project Number:00418-1 Examination of an Automated Cleaning Process using quantitative Detection of Protein and Hemoglobin and the Radionuclide Method 07-Jun-2018 - Project Number: 00418-2 Examination of a Manual Cleaning Process using quantitative Detection of Protein and Hemoglobin and the Radionuclide Method 07-Jun-2018 - Project Number: 25517-1 Validation of a Sterilization Process using Steam Sterilization in Pre-vacuum Mode Method MD 4.0: Sterilization validation of medical products with moist heat 12-Dec-2018 - Project Number: 25517-2 Validation of a Sterilization Process using Steam Sterilization in Pre-vacuum Mode Method MD 4.0: Sterilization validation of medical products with moist heat 12-Dec-2018
Syringes
Processing: - Completely disassemble including unscrewing of the cylinder.
Ultrasonic Inserts, Magnetostrictive
Processing: - Ultrasonic cleaning and disinfection as well as steam sterilization can be affected in suitable Hu-Friedy IMS-Cassettes.
Cleaning / Disinfection: -
For automated cleaning and disinfection in a Washer-Disinfector unit connecting rinsing adapters must be used, if the inserts are processed inside a cassette system. Otherwise open tray systems for the automated cleaning and disinfection or alternatively the manual cleaning and disinfection procedure are recommended.
Sterilization: - For sterilization use steam sterilization only. Do not expose to phenols or iodophors. - Do not use dry heat sterilization, or heat above 135 °C (275 F).
Ultrasonic Inserts, Piezo with Guardian
Processing: - Piezo Ultrasonic Inserts remain in the Guardian during the complete reprocessing cycle, also if reprocessed in cassettes. - Ultrasonic cleaning and disinfection as well as steam sterilization can be affected in suitable Hu-Friedy IMS-Cassettes.
Sterilization: -
For sterilization use steam sterilization only. Do not expose to phenols or iodophors.
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- Do not use dry heat sterilization, or heat above 135 °C (275 F).
Ultrasonic Piezo Handpiece
Sterilization: - The Piezo handpiece can be steam sterilized with all types of Steam Sterilizers at 134°C/ 15 minutes. Other sterilization parameters are not permitted.
Free Call: 00800 48 37 43 39 | Free Fax: 00800 48 37 43 40 E-Mail: info@hu-friedy.eu | Website: HuFriedyGroup.eu HuFriedyGroupEurope
Hu-Friedy Mfg. Co., LLC. • European Headquarters • Lyoner Str. 9 • 60528 Frankfurt am Main, Germany • HuFriedyGroup.eu All company and product names are trademarks of Hu-Friedy Mfg. Co. LLC., its affiliates or related companies, unless otherwise noted. ©2023 Hu-Friedy Mfg. Co., LLC. All rights reserved. HF-GB-17664/0723
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