AG Cuffill User Manual Hospitech Respiration Proprietary
Contents
1. If required cuff pressure may be reduced by pulling back the plunger until required pressure is achieved 5 Disconnect the AG Cuffill from the cuff inflation line NOTE The device automatically turns OFF 60 seconds after activation ATTENTION When disconnecting the Cuff pressure may be reduced by 1 2 mmHg cmH20 Range of measured cuff pressure Model HSCUFF0031 0 99 mmHg Model HSCUFF0041 0 99 cmH20 Accuracy of cuff pressure measurement Model HSCUFF0031 2 mmHg Model HSCUFF0041 2 cmH20 Instructions for Use cont 3 Adjusting Cuff Pressure See the following figure 1 Turn the AG Cuffill ON by pressing the power button on the right side of the display The display will blink twice showing the number of readings left and then will display 00 see section 4 Display 2 Position the plunger about half way out 3 Connect the AG Cuffill to the cuff inflation line 4 Adjust the plunger until the required pressure is achieved If the required pressure is not achieved disconnect the AG Cuffill pull the plunger 1 2 cc backward and repeat this step 5 Disconnect the AG Cuffill from the cuff inflation line NOTE The device automatically turns OFF 60 seconds after activation ATTENTION When disconnecting the Cuff pressure may be reduced by 1 2 mmHg cmH20O Recommended temperature operating range 10 C 30 C 50 F 85 F Volume delivered 0 10 cc in 0 5 cc graduations Display2. The AG Cuffill is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Warning The following warnings and informative tables are provided The AG Cuffill has been tested and found to comply with the limits for the medical devices to the IEC 60601 1 2 These limits are designed to provide reasonable protection against harmful interference in a typical residential installation This device generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity Recommended separation distance between portable and mobile RF communications equipment and the AG Cuffill The AG Cuffill is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the AG Cuffill can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the AG Cuffill as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter in meter Output power of 150 kHz to 80 MHz 80MHz to 800 MHz 800MHz to 2 5GHz Transmitter in Watts d 1 2VP d 1 2VP d 2 3VP For tra
3. airways The Hospitech AG Cuffill should be used only under medical supervision in hospitals pre hospital EMS extended care facilities and outpatient clinics where a patient may be intubated AN the AG Cuffil is intended for an air filled cuff and should not be used with liquids which will cause damage Dine AG Cuffill should not be Used for continuous monitoring It should be disconnected each time after use Handling Instructions The AG Cuffill is intended for air filled cuffs and should not be used with liquids The AG Cuffill should be kept in a dry environment during transport and storage Cleaning Instructions Wipe the surface thoroughly with an alcohol based disinfectant While cleaning prevent entry of any fluid into the AG Cuffill luer inflation line Before Use Make sure that the luer is clear of any obstruction and is open to ambient pressure Specifications Size Length 20 cm Diameter ID 15 mm Weight 18 gr Power CR1632 3VDC 130MAh battery Instructions for Use 2 Measuring Cuff Pressure See the following figure 1 Turn ON the AG Cuffill by pressing the power button on the right side of the display The display will blink twice showing the number of readings left and then will display 00 see section 4 Display 2 Push the plunger to the distal end of the syringe all the way in 3 Connect the AG Cuffill to the cuff inflation line and read the pressure value 4
4. 4 Display reads1H Blinks twice immediately after turn on in case number of readings left is greater than 99 Display reads 00 Normal Ready For Use Display reads UP Under Pressure Vacuum Display reads OP Over Pressure above 99 mmHg cmH20 Diagnostics Display reads E1 to E4 System is out of operational range Device unusable Display reads 01 or above Calibration Required Perform Calibration Calibration Calibration can only be carried out when the Cuffill is disconnected from the airway e Make sure that the AG Cuffill connector LUer is clear of any obstructions e Press and hold the Power Button for more than 5 seconds e followed by 00 should appear on the display If a value other than 00 appears the device is not usable Number of operations 100 EMC Compliance IEC 60601 1 2 RF emissions CISPR 11 Class B IEC 61000 4 3 IEC 61000 4 8 IEC 61000 4 2 Safety Compliance IEC 60601 1 1 3rd Edition
5. Guidance and manufacturer s declaration electromagnetic Immunity 5 AG Cuffill information regarding Electro Magnetic Compatibility EMC 6 As an electrical device the AG Cuffill has been tested for electromagnetic emissions and is susceptible to electromagnetic interferences within the required criteria of the IEC 60601 1 2 standard The EQUIPMENT is intended for use in the electromagnetic environment specified below The customer or the user of the EQUIPMENT should assure that it is used in such an environment i ee 2 oe T T T IEC 60601 Test Level Level Immunity Test Compliance IEC 61000 4 3 20V m 20V m Radiated Immunity 80 2500MHz 80 2500MHz MIL STD 461E 20V m 20V m 100kHz 1 50kHz 100kHz 150kHz 20V m 20V m 13 5MH 13 6MHz 13 5MH 13 6MHz Radiated Immunity NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the AG Cuffill is used exceeds
6. nsmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Notel At 80MHz and 800MHz the separation distance for the higher frequency range applies Note2 These guidelines may not apply in alll situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ONLY Qsite EU Gerrit van der Veenstraat 84HS 1077 EL Amsterdam The Netherlands Tel 31 0 20 81 1 0550 Fax 31 842 2131 42 Email QsiteEU qsitemed com Hospitech Respiration 20 Hamagshimim St P O B 7970 Kiryat Matalon Petach Tikva 0483 4934829 ISRAEL Tel 972 3 9 19 1648 Fax 972 3 9 19 1648 Email info hospitech co il Caution Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner Rx ONLY Hospitech Respiration AG Cuffill User Manual Hospitech Respiration Proprietary Information 20 Hamagshimim St P O B 7970 Kiryat Matalon Petach Tikva 4934829 ISRAEL Email info hospitech co il AG Cuffill 1 Description amp Identification for Use The Hospitech AG Cuffill measures and regulates the cuff pressure of Endotracheal tubes Tracheostomy tubes and Laryngeal Masks Airways supraglottic
7. the applicable RF compliance level above the ME EQUIPMENT or ME SYSTEM should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the V touch b Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m IEC 61000 4 8 Magnetic Immunity IEC 61000 4 2 Electronic Discharge 15 kVAir 9kV Contact 15 kVAir 9kV Contact Electro magnetic Guidance Level Portable and mobile RF communications equipment should be used no closer to any part of the AG Cuffill including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a and should be less than the compliance level in each frequency range o Interference may occur in the vicinity of equipment marked with the following symbol Co Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Increasing relative humidity will reduce the potential for ESD related difficulties Guidance and Manufacturer s Declaration Electromagnetic emission IEC 60601 Test 15 kVAir Level 9kV Contact Emission Test CISPR11 CLASS B Complies UMCUFFO0021 rev4 Eloctro magnetic Guidance Level
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