A127 Pump for Arthroscopy A127 Instructions for Use en
en This instructions for use contains information that is subject to copyright. All rights reserved. This instructions for use should not be photocopied, duplicated on microfilm or otherwise copied or distributed, completely or in part, without the approval of W.O.M. WORLD OF MEDICINE GmbH. We reserve the right to technical changes without prior notification due to the continuous further development of our products. Function or design may partially differ from the description in the instructions for use.
Symbols and Description Symbols and Description Follow instructions for use (white image on a blue background) Do not reuse Do not resterilize Caution Consult instructions for use Authorized for Sale or use by Physician only Type BF applied part Equipotentiality Degrees of protection provided by enclosures (IPCode) Protective earth (Ground) Alternating current Service Sterilized using ethylene oxide Non sterile Date of manufacture (YYYYMM-DD) Manufacturer Use by date (YYYY-MM-DD) Quantity No
Symbols and Description en Temperature limit Humidity limitation Atmospheric pressure limitation Do not use if package is damaged Waste management Transport conditions Storage conditions Recyclable packaging (Greendot symbol) Recycling PAP PE RFID tag, general Non-ionizing electomagnetic radiation
Table of Contents 1 Important User Notes ............................................................................................................................................................................................... 7 2 Safety Information ..................................................................................................................................................................................................... 8 3 General Information .............................
en 13 Technical Data ........................................................................................................................................................................................................... 52 14 Error and Warning Messages................................................................................................................................................................................ 54 15 Appendix ..............................................................
Important User Notes 1 Important User Notes en Read the manual carefully and become familiar with the operation and function of the device and the accessories before use during surgical procedures. Non-observance of the instructions listed in this manual can lead • to life-threatening injuries of the patient, • to severe injuries of the surgical team, nursing or service personnel, or • damages or malfunction of device and/or accessories.
Safety Information en 2 Safety Information Federal Law (only for U.S. market) CAUTION! Federal law restricts this device to sale by or on the order of a physician.
General Information 3 General Information 3.1 Description of the Device en The device itself is non-invasive and designed for use in non-sterile areas. It pumps medically sterile irrigation fluids through a sterile tube. These fluids are used to distend and irrigate corresponding body cavities to provide space and improve visibility for the attending physician. The device can be used with electrolyte-free media (e.g., glycine 1.5 % or sorbitol 3.0 %) and with isotonic, electrolyte-containing media (e.
General Information Wrist joint en 30 mmHg Each surgery and each patient require different parameters. The values indicated by manufacturer are therefore only recommendations and are not intended to substitute or replace the expertise of the surgeon. The maximum flow is limited to 1.5 l/min on the device side and is automatically reduced by the pump once the nominal pressure has been reached. Clinical use When performing monopolar electrosurgery, only non-conductive irrigation fluids may be used.
General Information en WARNING! Check all factory settings Factory settings are not mandatory settings for the physician. The physician is responsible for all settings affecting the surgical procedure. WARNING! Original accessories For your own safety and that of your patient, use only original accessories. WARNING! Acoustic signals Different default settings of the warning message for identical or similar devices in the operating room may cause a risk due to conflicting acoustic signals.
General Information en WARNING! Contamination Do not use device and/or accessories if signs of contamination are detected. Make sure the device or/and accessories can no longer be operated until a qualified service technician conducts the appropriate tests and repairs. WARNING! Condensation / Water penetration Protect device from moisture. Do not use if moisture has penetrated the device.
General Information en WARNING! Obvious defects Never use the device if it has suspected or confirmed defects, especially if these involve the power plugs or the mains power supply connection cables. In this case have the device repaired by authorized service personnel. WARNING! Instrument replacement Stop the device using the START/STOP key if replacing the instrument during surgery.
General Information en CAUTION! Endoscope The device may only be connected with endoscopes designed for and featuring the technical specification permitting such a combined use. Any utilized endoscopes must comply with the most recent versions of EC 60601-2-18 and ISO 8600. Combining/connecting with other devices generates a medical electrical system (MES). The system configurator is responsible for compliance with the standard IEC 60601-1 / EN 60601-1 in its latest version.
General Information en CAUTION! Ventilation of the device • Avoid device overheating. • Ensure free air circulation especially to the bottom and rear of the device (rear panel distance of at least 10 cm). CAUTION! Patient group There are no restrictions as to the specification of the patient group when using the device as intended and its use does not endanger the patient's health. CAUTION! Cleaning the Device Do not sterilize the device.
General Information en WARNING! Pressure settings The nominal pressure of the described device can be preset to values described in these Instructions for Use. Select the optimum pressure based on the patient profile, including but not limited to blood pressure, height, weight and age. The manufacturer recommends pressure settings for different areas of application; however these are suggestions only and are not intended to substitute or replace the expertise of the surgeon.
Device Setup 4 Device Setup The operation of the device is reserved for medical staff with the relevant professional qualifications trained to use the device. 4.1 en Setting up Scope of Delivery • Device A127 • Instructions for Use • Power cable Delivery inspection WARNING! Check for defects Check the product and the packaging for defects prior to use. Do not use if package is damaged.
Device Setup en WARNING! Falls and crashes Place the device on a stable and level surface. Cables must be laid safely. Tubes between the device and the patient must not create any obstruction. WARNING! Condensation / Water penetration Protect device from moisture. Do not use if moisture has penetrated the device. WARNING! Not explosion-proof The device is not explosion-proof. Do not operate the device in the vicinity of explosive anesthetic gases and not in the vicinity of oxygen-enriched environments.
Device Setup en CAUTION! Ventilation of the device • Avoid device overheating. • Ensure free air circulation especially to the bottom and rear of the device (rear panel distance of at least 10 cm). CAUTION! Device setup Device should be positioned outside of the sterile area in such a way that • it can be easily disconnected, • it is easy to use and switch off and on, • it allows an easy monitoring of the display values, device functions, and access to the control elements.
Device Setup en CAUTION! Mains connection • Make sure the available mains voltage matches the data listed on the type label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and may destroy the device. • Make sure the connection data and technical specifications of the power supply comply with DIN VDE or national requirements.
Device Setup en CAUTION! Pump in place Make sure the toggle screw is tightened sufficiently to fasten the pump securely in place. Also check that the toggle screw remains tightened. 1. Position the pump on the rod of the stand at the desired height, usually between 80 and 120 cm (example: Base of stand ø = 65 cm, maximum height of h < 100 cm recommended). 2. Tighten the toggle screw on the rear of the pump. 4.3.
Operating the Device 5 en Operating the Device CAUTION! Combination of devices Comply with the relevant standards IEC 60601-1 / EN 60601-1 when combining several devices. 5.1 Front of the Device Familiarize yourself with the control and function elements at the front of the device. Fig.
Operating the Device Fig. 5–3 Rear of the device (18) (19) 5.4 (20) (21) (22) (18) (19) (20) (21) (22) en Service interface Toggle screw Tripod mount Mains socket Fuse holder Turning the Device On 1. Plug the device into the power outlet. The mains voltage LED lights up green (Front of the device [} 22] (14)). 2. Make sure a tube set is not inserted into the tube retainer. 3. Press "ON" key (Front of the device [} 22] (13)). The device switches on. 4.
Operating the Device en WARNING! Reprocessing of sterile disposable products Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! Do not reprocess the product.
Operating the Device – The pump can be started/stopped as often as desired with a tube set invalidated during the current application if the tube set is not removed. Once the tube set is removed, it can no longer be used. en – If the inserted tube set has already been invalidated, an error message E02 is displayed until the tube set is removed. – If an invalid tube set is inserted, an error message E03 is displayed until the tube set is removed.
Operating the Device en Fig. 5–4 Tube set elements (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) Protective caps Spikes Tube clamps Y-connector Inflow tube Ring Roller tube Pressure chamber with membrane and transponder Instrument tube Luer lock connector The irrigation tube set consists of three tube sections (roller tube, inflow tube, and instrument tube), a Y-connector, 2 spikes with protective caps, 2 tube clamps and a pressure chamber with membrane and transponder.
Operating the Device Fig. 5–5 Inserting tube set (11) (2) (5) (7) (8) (2) (9) (10) (11) (12) (13) (5) Spikes Inflow tube Roller tube Pressure chamber with membrane and transponder Instrument tube Luer lock connector Irrigation fluid bags Roller wheel Tube retainer (7) (13) (8) (12) (9) (10) 1a. Disposable tube set - To be carried out by non-sterile technician: Open outer packaging • Open outer packaging of the tube set.
Operating the Device en CAUTION! Inserting the tubes Instrument tube (9) and inflow tube (5) must be inserted horizontally towards the front without twisting the roller tube. Fig. 5–6 Position roller tube (5) (2) (5) (7) (9) (12) (13) Roller tube Pressure chamber Inflow tube Roller tube Instrument tube Roller wheel Tube retainer (5) (7) (12) (13) (9) (8) The device is now ready for use. 5.
Operating the Device Fig. 5–7 Hanging fluid bags (1) (2) (3) (1) en Irrigation fluid bags Spikes Tube clamps (2) (3) 5.9 Setting Nominal Values The nominal pressure can be set while the device is being operated or while stopped. Adjust settings by tapping the INCREASE or DECREASE key on the control foil (Fig. Front of the device [} 22]). Preselecting the nominal pressure Tap the INCREASE or DECREASE key on the control foil to change the nominal pressure values.
Operating the Device en 6. The pump detects when the tube is filled. The device starts the instrument recognition process automatically as soon as pressure conditions have stabilized. This may take a few seconds.. 7. This is followed by three short irrigation cycles. 8. Close the inflow valve. Do not press the START/STOP key. The instrument recognition is lost if the START/STOP key is pressed. 9. Continue with the surgical procedure.
Operating the Device en NOTE! Safe disconnection from power supply A safe and all-pole disconnection of the product from the power supply is only ensured by disconnecting the power cord.
Safety Functions 6 en Safety Functions The electronic components continuously monitor the proper function of the device. Device malfunctions are indicated with audible warning signals (beeps), error messages, and/or the blocking of device functions. A table listing a summary of possible error and warning messages is provided in Chapter Error and Warning Messages [} 54]. 6.1 Device Self-Test After being switched on, the device performs a self-test of the sensors, the motor, and electronic components.
Function Test 7 Function Test en WARNING! Functional test The functional test must be performed by the user prior to each surgery. WARNING! Checking the warning signals The warning signals must be checking prior to each device use. The system is to be set up so that all warning signals can be perceived. WARNING! Original accessories For your own safety and that of your patient, use only original accessories.
Function Test en 3. Start the pump with the START/STOP key. The START operating mode LED (Fig. Front of the device [} 22] (3)) lights up. Wait until the instrument recognition is finished (the instrument is outside of the joint and at a working height of ± 10 cm of the operation height, see Chapter Starting the Device [} 29]). 4. Close the inflow valve after the instrument recognition is finished. 7.3 Checking the WASH Function 1.
Using the Device during Surgery 8 Using the Device during Surgery en WARNING! Functional test The functional test must be performed by the user prior to each surgery. WARNING! Irrigation fluid The physician must determinate a distension fluid suitable for the application and medical procedure. Make sure the device is at the same height as the instrument. A difference in height affects the pressure readings due to hydrostatic pressure. Before surgery Fig. 8–1 Before surgery 1.
Using the Device during Surgery en NOTE! Disposal Comply with hygiene rules and regulations when disposing of the tube set, collected fluid, and the suction container.
Care and Maintenance 9 Care and Maintenance en Special care is necessary when servicing, maintaining, and storing the device and its accessories to maintain the functionality of the device and its accessories. NOTE! Service or maintenance work Service or maintenance work may not be carried out during surgery. 9.1 Maintenance Intervals The manufacturer stipulates that qualified personnel or hospital technicians must regularly test the device to assess its functionality and technical safety.
Care and Maintenance en WARNING! Risk of electrical shock To prevent electrical shock, do not open this device. Never open this device yourself. Notify the authorized service technicians of any required repairs. WARNING! Modification of the device This device may not be modified without the permission of the manufacturer. WARNING! Modified device If the device is modified, suitable examinations and tests must be carried out to ensure further safe use of the device. 9.
Care and Maintenance 9.5 Care of the Reusable Tube Set (NOT FOR SALE IN USA) en All reusable inflow tubes must be cleaned, disinfected, and sterilized before use. This applies in particular to the first use after delivery since the product is delivered non-sterile. Effective cleaning and disinfection are an essential prerequisite for effective sterilization. The device A127 can be used with a reusable tube set listed as an accessory (see Chapter Accessory List [} 48]).
Care and Maintenance It is imperative to comply with the concentrations, temperatures, and exposure times, as well as the post-rinsing requirements specified by the manufacturer of the cleaning agent and/or disinfectant. en Make sure that the entire tube set is rinsed and dried. If necessary, rinse or dry the tube set both from the Luer lock side and from the side of the spikes. Never clean the product with metal brushes or steel wool but with a soft cloth.
Care and Maintenance Fig. 9–2 Pressure chamber membrane and its position in the inflow tube set (7) (2) (8) (3) (4) (5) (1) (1) (2) (3) (4) (5) (6) (7) (8) Pressure chamber Membrane Lip of the membrane Groove Notch Strap Spikes with protective caps Tube clamps (1) (6) 9.5.2.2 Pretreatment Pretreatment must be carried out both during automated and manual cleaning and disinfection.
Care and Maintenance 9.5.2.3 Cleaning and Disinfection en An automated process (cleaning and disinfecting equipment) should be used if possible. A manual process - even when using an ultrasonic bath - should be used only if an automated process is not available or not possible due to the significantly reduced efficiency and reproducibility.
Care and Maintenance • A disinfectant with tested effectiveness (e.g. VAH/DGHM or FDA/EPA approva/ clearance/Registration or CE marking) is used which is compatible with the cleaning agent used. en • The chemicals used are compatible with the products. Combined cleaning/disinfecting agents should not be used if possible. Combined cleaning/disinfecting agents can be used only in cases of very low contamination (no visible impurities).
Care and Maintenance 9.5.2.6 Reinstalling the Membrane en Reinstalling membrane before sterilization (see Fig. Pressure chamber membrane and its position in the inflow tube set [} 41]): Place the lip of the membrane (3) into the ring groove (4) of the pressure chamber. The strap (6) must be positioned in the notch (5) provided for this purpose. Press the lip of the membrane into the groove (4). A properly inserted membrane is flush with the pressure chamber and exhibits no wrinkles. 9.5.2.
Care and Maintenance Ethylene oxide sterilization is possible but not validated by the manufacturer. en 9.5.2.9 Storage After sterilization, the products in the sterilization packaging must be stored dry and dust-free. 9.5.2.10 Reusability The products can be reused up to 20 times, provided they are undamaged and uncontaminated, and used with due care; any further use or the use of damaged and/ or contaminated products is the responsibility of the user. If disregarded, any liability is excluded.
Annual Inspection en 10 Inspection tests Annual Inspection The following tests are designed specifically for trained personnel or a hospital technician. The operation of the device as well as its functionality and serviceability are easily checked. Each test conducted has to be documented with date and signature in the test log. Each test conducted must be documented with date and signature on the test log (Chapter Test log [} 56]).
Annual Inspection 5. Select the following values: Nominal pressure: 150 mmHg 6. Press the START/STOP key. The START operating mode LED (Fig. Front of the device [} 22] (3)) lights up. The roller wheel starts to turn. 7. Fill tube set completely with fluid. Wait until the instrument recognition has finished. 8. Close the clamp (Fig. Tube set elements [} 26] (3)). 1. Empty measuring beaker. 2. Open clamp (Fig. Tube set elements [} 26] (3)) and stop after 30 seconds. 3.
Accessory List en 11 Accessory List Article description Order number Disposable tube set*, Luer lock connector, and spikes, only inflow T0449-01 Reusable tube set*, Luer lock connector, and spikes, only inflow (NOT FOR SALE IN T0454-01 USA) Power cable 2.0 m, EU Z0101-01 Power cable 2.5 m, US Z0102-01 Power cable 1.8 m, UK Z0176-00 Power cable 1.
Electromagnetic Compatibility 12 Electromagnetic Compatibility en CAUTION! Accessories To ensure compliance with the requirements of IEC 60601-1-2 in the current version, the device A127 must be used only with the accessories listed in Chapter Accessory List [} 48]. Precautionary measures Medical devices are subject to special safety and protective measures concerning electromagnetic compatibility (hereafter abbreviated as EMC).
Electromagnetic Compatibility 12.3 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity en The device A127 is intended for use in an electromagnetic environment as described below. The user/operator of the device A127 should make sure the device is operated within such an environment.
Electromagnetic Compatibility Test frequency Band (MHz) (MHz) Service 1720 GSM 1800; CDMA 1900; Pulse moduGSM 1900; DECT; lation 2 LTE Band 1, 3, 4, 217 Hz 25; UMTS 1845 1700-1990 1970 Modulation Maximum (W) power Distance IMMUNITY TEST LEVEL (V/m) (m) 0.3 28 Pulse modu802.11 b/g/n, lation 2 RFID 2450, LTE 217 Hz Band 7 0.3 28 Pulse modulation 0.2 WLAN 802.11 a/n 217 Hz 0.
Technical Data en 13 Technical Data Type designation A127 Product name A127 Manufacturer information: W.O.M. WORLD OF MEDICINE GmbH Salzufer 8, 10587 Berlin Software version Can be determined by the authorized service technician Mains voltage range [V] 100-240 Supply frequency range [Hz] 50 / 60 Fuse designation 2x T 3.15 A H 250 V Power consumption Current [A] Power [VA] Normal operation 100 V/60 Hz 1.15 115 Normal operation 240 V/50 Hz 0.
Technical Data Set output pressure range [mmHg] 5 to 150 en Measurement range Flow [l/min] 0.5 to 1.5 Pressure [mmHg] 0 to 300 Accuracy Flow [%] ±10 % Output pressure [mmHg] ±4.5 Maximum dimensions (Width x Height x Depth) (with 240 x 103 x 255 [mm] toggle screw, projecting as much as possible): Maximum dimensions (Width x Height x Depth) (without 240 x 103 x 221 [mm] toggle screw): Weight 2.
Error and Warning Messages en 14 Error and Warning Messages Informational signals Optical Acoustic Priority Cause 000 (for 3 s) 1 low volume beep Information Disposable/reusable tube was accepted number of remaining cycles: 0 Disposable/reusable tube was accepted xxx (for 3 s) 1 low volume beep Information n/a 1 low volume beep Information Self-test successfully completed n/a 1 low volume beep Information Key confirmation Optical Acoustic Priority Cause Overpressure indicator 3 b
Error and Warning Messages Technical warnings – device error Optical Acoustic Priority Cause 5 beeps High Communication error 5 beeps High Electronics error 5 beeps High Keyboard error 5 beeps High Calibration error en E50 service icon, red (constant) E55 service icon, red (constant) E58 service icon, red (constant) E59 service icon, red (constant) 55 / 62
Appendix en Date 56 / 62 Result 15 Appendix 15.
Appendix 15.
Glossary en Glossary Basic function test The basic function test checks the basic function of the device and is part of the annual inspection. EMC The electromagnetic compatibility describes the ability of a device to function satisfactorily within an electromagnetic environment without adding unacceptable electromagnetic interferences/disturbances to the environment that may cause problems for other devices or equipment located nearby.
List of Figures List of Figures Fig. 5–1 Front of the device ........................................................................................................................................................................ 22 Fig. 5–2 Device side....................................................................................................................................................................................... 22 Fig. 5–3 Rear of the device ....................................
Index en Index 35 8 37 Prepare basic function test Preparing the pressure measuring test Preselecting the nominal flow Preselecting the nominal pressure Pressure > 200 mmHg Pressure > 250 mmHg 35 R A After surgery Authorized service technician Authorized trained personnel B Before surgery C Care and maintenance Clinical use Connecting the instrument Contamination 8 10 27 8 D Delivery inspection 17 32 8 F Federal Law (only for U.S.
