6.7.8.3.1-11 - When the SOM receives a toggle failure message from MCB, the SOM shall send a message to Remote Service.6.7.8.3.1-12 - When the MCB receives a successful toggle message from all the boards, AND if the SOM OS update is pending the MCB shall send a message to the FUD to present the finalize software installation with OS update screen.6.7.8.3.1-13 - When the MCB receives a successful toggle message from all the boards, the MCB shall send a message to the SOM to inform the Remote Service server of toggle completion.6.4.1-5 - Where the [GUI] equipped the Hoist, the Hoist shall display an information to pull down the sling if no more battery and patient weight below than 20 kg (TBC).6.6.8-2 - When Low battery level (ELV-4776) detected, the Hoist shall2. While a High_Low key press is detected inform through audible ELV-3222 indicators.6.6.8-3 - When Empty battery level (ELV-4777) detected, the Hoist shall:2. Permit a complete lowering for the load range5. While a High_Low key press is detected inform through audible ELV-3222 indicators.TODO Requete Certificate with Product ID ? When and how ?6.7.8.3.1-14 - When the MCB updates the boards following a power cylce, the MCB shall display the home screen till the MCB receives a loading success or loading failure message from the SideCom micro controller3-2 - - Approved Server to connect ACME product using WiFi to stream the data relative to the caregiver usage to the Hospital server.3-3 - - The person operating the product to assist in the mobility and care of a patient3-4 - - Central Suspension Point It is the reference point on the hoist to be used for measurements - the reference is the axis of the hooking area.3-5 - - Cumulocity is a unique IoT equipment management tool. Cumulocity allows to manage equipment throughout its lifecycle. Monitor the status of the devices, minimize downtime by visualizing key information, alarms and critical errors in its specific dashboards.3-6 - - Electronic Medical Record - Server managed by the hospital3-7 - - A device used to lift or lower.3-8 - - A charging system installed on straight rails which convert the AC power to DC power to charge the battery in the Hoist.3-9 - - Movement in the horizontal plane parallel to the lifting surface.3-10 - - The time span during which the Product shall serve its intended use.3-11 - - A lift cycle is an up and down movement on the same distance on both sides.3-12 - - Existing Liko Overhead Lift System3-13 - - Existing Liko Overhead Lift System3-14 - - Greatest permissible load that can be applied to the hoist system without design margin, equivalent to maximum patient weight.3-15 - - Existing Liko Overhead Lift System3-16 - - SCRM => Denotes work in SmartCare Remote Management customer facing portal (cloud based), - SCRM On Prem=> Denotes work in SmartCare Remote Management On Premises portal3-17 - - Main user control (first intention), - Out of backup control in case of failure.3-18 - - If needed, a redundant interface located on the Hoist.3-19 - - Each side of a connecting interface is connected in such a way that an intended User action is required to disconnect.3-21 - - Safe Working Load - The SWL is the user mass with additional design margin to cover misuse. - The SWL is an R&D value to design - no claim on user documentation.3-22 - - Portable Power Source is another way to name the battery3-24 - - Optional feature for motorized lateral motion3-25 - - A connection mechanism that connects intersecting rails.3-26 - - Operation mode where the hoist is shutting down some functionalities to optimize its power consumption.3-27 - - Operation mode where the hoist is shutting down more functionalities to further optimize its power consumption.3-28 - - Operation mode for standard use on battery.3-29 - - Operation mode where the hoist is charging its internal battery.1. Tier 2 Hoist: not to exceed 10.0 kg (TBC)3-30 - - Operation mode in which the battery is disconnected from the system to prevent any power consumption. This is used for transport purpose and long-term storage.3-31 - - Command done by the User to either:Start or stop Vertical Movement Start or stop Dynamic Rails movements Use of or display on the Hand Control Screen3-32 - - Current capacity of a battery compared to its nominal capacity (established when it was first created), expressed in percentage.3-33 - - Remaining capacity available in a battery at a given time and regarding its current maximum capacity, expressed in percentage.2. Tier 3 Hoist: not to exceed 11.0 kg (TBC)3-34 - - Missing capacity in a battery at a given time and regarding its current maximum capacity, expressed in percentage. It linked with ELV-4792 - State of Charge (SoC) by the formula DoD = 1 - SoC.3-35 - - A system which transfers power to or from Hoist from a Multi Station location either on:End of rail Side Rail Switch Turn Table3-36 - - A charging system in the Hand Control that transfers power from the wall charger to the Hoist.5.1 Physical Constraints 5.1-1 - For all product configuration, the Hoist weights shall respect the following:5.1.1 Hoist Dimensions and position relative to the ceiling 5.1.1-1 - The Tier 2 and 3 Hoists shall have an external dimension of (see figure 2):Length (B) not to exceed 390 mm (TBC) Width (A) not to exceed 245 mm (TBC) Height (C) not to exceed 160 mm Height (Ccsp) not to exceed 210 mm5.1.1-2 - The Hoist length (B) and width (A) shall be symmetric +/-10 (TBC) mm about the Lift Strap.5.1.1-3 - The Hoist shall have a CSP distance (E) from the Upper Lift position to the Lower Lift position of at least 2500 mm illustrated in Figure 2.5.1.1-4 - The clearance between the upper side of the Hoist enclosure and the lower face of the rail/dynamic rails i.e. "D" dimension ( see figure 2) shall be 30 0 -2.5 mm.5.1.1-5 - Where embedded solution apply (rail, turntable), when plays of the Hoist with its carriage are on a side, the clearance between the Hoist enclosure and the ceiling or rail devices shall greater than 0 mm (TBC).5.2.1 Hoist perception and audible feed-backs 5.2.1-1 - When vertical movement is trigger, the Hoist shall be under a perceptible sound level of 52 dBA (TBC) measured from a radial distance of 1 m (TBC need to check the distance between the patient head and the Hoist) starting from the central of the hoist (1 meter sphere starting from the central of the hoist).5.2.1-2 - When vertical or horizontal movement of the product, the vibration level of the Hoist enclosure, per ISO 2631-1, shall be below of 0.015 m/s² (TBC) for the 3 directions ("X,Y,Z" axis).5.2.1-3 - The usage audible feedback shall be chime type i.e.:Frequency: La - 600 Hz - 0.2 second Do - 523 Hz - 0.2 second Mi - 659 Hz - 0.1 secondPulse: 2 pulses in a salve - 200 +- 50 ms between salve Sound pressure level: 67.5 +-2.5 dB at 1 meter5.2.1-4 - The Error audible feedback audible feedback shall be alarm type i.e.:Frequency: 800 +- 50 Hz Pulse: 3 pulses in a salve Pulse Duration: td = 200ms +/-50ms Time between 2 pulses: ts = 125 to 250 ms Sound pressure level: 67.5 +-2.5 dB at 1 meter5.2.2 Hoist cycles and Real World Usage Profile 5.2.2-1 - In relation with ELV-1256, the Hoist shall operate 120 seconds mini, in continuous i.e. a complete cycle starting from the top, at the bottom, at the top of vertical lift cycle.5.2.2-2 - Based on ISO EN10535 2021, the Hoists shall achieve the lift cycle defined by § 4.9.2.8.5.2.2-3 - Based on RWUP NPD11646, the Hoists shall achieve at min a usage of: (To change value, see excel file in attachement)5.2.2-4 - Based on RWUP NPD11646 and cycle just below, the Hoists shall achieve a max strap length usage of: (To change value, see excel file in attachement of ELV-4054)5.2.2-5 - If the Hoist triggers a High/Low function protection due to lift motor over usage, downward motion shall be allowed.5.2.2-6 - The Hoist shall manage a margin on over usage protection of High/Low motor to permit a downward & upward motion at the end of a period of 60 (TBC) seconds.5.2.2-7 - Where [GUI] available, when the lift motor over usage protection is active, the Hoist shall provide waiting period and upward motion not available visual feedback.5.2.3 Emergency function usage profile 5.2.3-1 - When loaded at the Max Load, after a minimum of 400 cycles per year of activations & deactivation, the Emergency Stop shall be operational.5.2.3-2 - When loaded at the Max Load, after a minimum of 12 emergency lowering per year on at least 40 cm of unrolled strap per lowering, the Emergency Lowering shall be operational.5.3 Operating Environment 5.3-1 - The Hoist shall comply at least with IP34 (TBC) index specify by IEC 60529.5.4.1 Interface with Carriage 5.4.1-1 - The Hoist carriage shall be operational when attached / detached from the Lateral Mobility 4 times/year.5.4.2 Interface with User Controls 5.4.2-1 - The user control of the Hoist shall be adjustable to be placed between a height "G" of 800 mm to 1200 mm above the floor.5.4.2-2 - The CSP point of the Hoist shall provide an emplacement to plug the User Control and keep in place when the hoist move for transfer.5.4.2-3 - The Hoist shall provide a User Control connector:3. Accessible to plug/unplug without the use of tool Answered the IP constraint of the Hoist (ELV-1309) Support a traction force of 200 N at an angle not to exceed 60 degrees relative to vertical axis.5.7 Design Constraints 5.7-1 - When using the user control, the movements trigger shall:1. Be active only while the corresponding control is active (Hold to Run)2. For a different movement requests, the second request halts execution of the first while there is more than 1 request in same time.3. The Emergency stop and lowering control has priority on the other movements.5.7-2 - The Hoist shall trigger an electrical movement:6.2-4 - When these events occurs during vertical movement:3. If there is a state change from key release to press While the intended user fonction pressed Excepted if the intended user fonction pressed beyond a period of time defined by ELV-3324 (failure management - user control see item 19).5.7-3 - The Hoist shall stop a electrical movement if there is a state change from key press to release.5.7-4 - When the Hoist generates indications at the same time, the system shall use the prioritization order:Critical Error Weight Over load Emergency stop Over usage Max angle/Twist of the lift strap Battery recharging needed Service requires6.1-2 - The Hoist shall block the vertical drift within 0 0/+5 mm during 2 hours.5.7-5 - Except for the lift strap, the emergency lift strap and the user control wire, all moving parts associated of the Hoist shall be enclosed.5.7-6 - When is present, the protections removing shall be only possible by the use of a tool according to ISO 10535:2021 § 4.1.4.1.a.5.7-7 - The design of the Hoist shall be in a way that the fasteners and parts cannot be unfixed manually.5.7-8 - The accessible area of the Hoist i.e. the CSP, Strap, Hoist enclosure shall be smooth to avoid aggressive contact with the user and the patient specify by IEC 60601-1-2005 §9.3.5.7.1 Hoist protection 5.7.1-1 - The exposed parts of the Hoist shall withstand Ultraviolet (UV) light to avoid risk of discoloration or loss of function.5.7.1-2 - The metallic surfaces of the Hoist shall be protected from corrosion to answer:3. Total of the corroded surface: ≤ 5 % Protection and Aspect class: Rp=4; Ra=4 Deterioration degree: s A5.7.1-3 - The external ports of Lift Control Board of the Hoist shall have:6.1 Support Load 6.1-1 - The fixed HOIST shall manage Safe Working Loads:1. Tier 2 Hoist: Max Load of 200 kg + accessories supported of 18 kg = 218 kg of load with design margin (TBC)2. Tier 2 Hoist: Max Load of 250 kg + accessories supported of 18 kg = 268 kg of load with design margin (TBC)3. Tier 2 Hoist: Max Load of 272 kg + accessories supported of 18 kg = 290 kg of load with design margin (TBC)4. Tier 3 Hoist: Max Load of 300 kg + accessories supported of 18 kg = 318 kg of load with design margin (TBC)5. Tier 3 Hoist: Max Load of 350 kg + accessories supported of 18 kg = 368 kg of load with design margin (TBC)6. Tier 3 Hoist: Max Load of 363 kg + accessories supported of 18 kg = 381 kg of load with design margin (TBC)7. Tier 3 Hoist: Max Load of 454 kg + accessories supported of 18 kg = 472 kg of load with design margin (TBC)6.1.1 Single Fault Safety of support load function 6.1.1-1 - The Hoist shall guarantee a lifted patient does not fall in the event of a single-fault condition of the drivetrain.6.1.1-2 - The Single Fault Safety of High/Low function shall not untimely triggering during vertical lift or emergency lowering.6.1.1-3 - When the Single Fault Safety mechanism triggers, the Hoist shall stay safe.6.2 Lift Patient 6.2-1 - When an High/Low command is triggered, the Hoist shall accelerate to achieve the vertical speed (ELV-1256) in 2.5 (TBC) ± 0.5 seconds without joggle.6.2-2 - The Hoist CSP shall have vertical movement speeds of 50 ±15 mm/sec (TBC) without joggle & be the same on the way down or on the way up ±5 mm/sec (TBC).6.2-3 - When these events occur prior the High/Low activation:2. Reach Angle of the lift exceeded (ELV-2009, ELV-2010)the Hoist shall prevent the vertical upward movement & manage Emergency stop by specification of §6.4.Halt High/Low command Load exceeds 1.5 (+0 / -0.20) X Max Load (TBC) Lift motor over usage protection triggered Reach Angle of the lift exceeded (ELV-2009, ELV-2010, ELV-3049) Twist of the strap (see ELV-ELV-3049)the Hoist shall halt the vertical movement within 1 seconds and 20 mm without joggle.6.2-5 - When the upper or lower end of the vertical lifting range is going to be reach, even if user requests the intended control, the product shall:1. Slowdown and halt vertical movement 20 mm ± 5 prior the end stop in within 1.5 seconds ± 0.5 without shock6.2-6 - Exclusively from 0° to 22° angle of the load gravity center at the CSP point, illustrate by Figure 3 'Max Lateral Angle "a"', the Hoist shall permit a lift movement.6.2-7 - Exclusively from 0° to 3° angle of the load gravity center at the CSP point, illustrate by Figure 3 'Max Front Angle "b"', the Hoist shall permit a lift movement.1. guide the lift strap to prevent to enter twisty/folding in the lift housing for a strap twisted under 89° in a distance specify by figure 3 "c"2. stop the rewind of the strap when twisted more than 89° in a distance specify by figure 3 "c".6.2-9 - The Hoist shall prevent the lift strap from folding when entering the Hoist housing.6.2-10 - When the strap reached the fully extended position, the Hoist shall prevent to wind up the strap in the wrong direction.6.2-11 - When the vertical movement speeds is above than 250 mm/sec (TBC) the Hoist shall generate a error code specify by ELV-3324 "24"6.2-12 - The geometry of the Hoist CSP point shall prevent object hooking.6.2.1 Lift Patient User Interface 6.2.1-1 - The Hoist access to up and down function shall be in 1 action max.6.4 Emergency function management 6.4-1 - When the emergency function triggered, the angle management of the strap ELV-2009 ELV-2010 ELV-3049 shall be shutdown to permit emergency lowering even if there is a strap angle.6.4.1-2 - The Hoist shall contain the following symbols placed on the Hoist near the Emergency Stop / Emergency Lowering & on the Emergency Stop / Emergency Lowering user controls:3. At the lower side of the Hoist cover, Centered under the rail, At a distance from the nearest edge of the lift strap to the Emergency control more than 100 mm6.4.1-4 - The user control shall provide indications when the emergency stop is activated.6.4.1-6 - Up to a vertical downward force of 80 N (TBC), the Emergency control shall be operational and have no observable damage.6.4.1-7 - Starting from 81 N (TBC relative to the motor break control at 50 N), the Emergency Stop strap shall detach from the Hoist.6.4.1-8 - The Hoist Emergency Interface shall be adjustable to be placed between a height "H" (Figure 2) of 1650 ±50 mm above the floor .6.4.1-9 - To differentiate the Emergency stop position from the Emergency lowering, the Emergency interface shall provide an additional effort index point of 3,5 ± 1 N (TBC) for the 2 positions & a safety stroke of 15 mm (TBC) between these 2 fonctions.6.4.2 Emergency Stop 6.4.2-1 - An Emergency Stop activation shall break and isolate the main circuit to stop all movement produced electrically (High/low, Dynamic Rails) excluded emergency lowering.6.4.2-2 - While the Emergency interface (stop and lowering) is activated, the Hoist shall:2. Not cause interruption of Hoist charging (ELV-3327)6.4.2-3 - While the Emergency stop is activated, the Hoist shall forbid the vertical drift within 0 0/+5 mm during 2 hours.6.4.2-4 - When an Emergency stop occurs, the Hoist shall halt vertical movement within 15 mm of strap length.6.4.2-5 - When resetting the Emergency stop, the hoist shall not restart but only permit restarting.3. Activate with an applied force between 5 N and 10 N4. Deactivate with a different action than used for activation5. Deactivate with an applied force between 5 N and 10 Nat an angle of ±25 degrees (TBC) from the vertical plane illustrated Figure 4.6.4.3 Emergency Lowering 6.4.3-1 - The emergency lowering shall be operable if and only if the Emergency stop is in progress.3. Provide a step feeling between emergency stop & emergency lowering activation4. Activate with an applied force between 5 N to 70 N5. Deactivate with a different action than used for activation6. Deactivate with an applied force between 5 N to 70 Nat an angle of +/-25 degrees from the vertical plane illustrated figure 4.6.4.3-3 - From a load of 25 kg (TBC) to 454 kg, the Emergency Lowering speed shall fit the same downward speed than the main usage i.e. ELV-1256 without joggle.6.4.3-4 - From a load of 13 kg to 20 kg, the pulling effort on the sling to lower the patient on the floor shall be under 7...10 kg (TBC) within an Emergency Lowering speed with the main usage downward speed ELV-1256.6.4.3-5 - When an Emergency lowering is stopped, the Hoist shall halt vertical movement within 1 second and 20 mm.6.4.3-6 - When the lift strap reached the fully extended position due to emergency lowering event, the Hoist shall prevent to wind up the strap in the improper direction.6.4.4 Specificity of lateral movement 6.4.4-1 - When an Emergency stop occurs, the Hoist shall stop to power lateral movementTolerated differences between results: Whatever the maximum permissible variation between results, each weighing result must not exceed the maximum permissible error for the load in question. Over the entire measurement range, the result must not exceed the maximum permissible error.Test condition The test must be performed 0 to Max weight with 5 steps in the ramp up and with a symmetrical descent (weight and load) back to 0.Test acceptance criterion: The error measured for each of the 5 steps must not exceed the MPE.6.5.1-2 - Digital indication subject to overload: Removing or depositing an overload equal to 1.4 times the actual scale interval, i.e. 1.4 * 100 = 140 g, on the instrument in equilibrium without impact, must unambiguously modify the indication.Note : - EN45501 §3.8.2.2 - For user6.5.1-3 - Effect of temperature on zero load indication The zero or near-zero indication must not vary by more than one verification step for an ambient temperature difference of 5°C.6.5.1-4 - Creep For any load held on an instrument, the difference between the indication obtained immediately after the load has been deposited and the indication observed during the following 30 min must not exceed 0.5 e, i.e. 50g . However, the difference between the indication obtained after 15 min and that obtained after 30 min must not exceed 0.2 e, or 20g. If these conditions are not met, the difference between the indication obtained immediately after the load has been deposited on the instrument and the indication observed during the following four hours must not exceed the absolute value of the maximum error tolerated at the load applied.6.5.1-5 - Durability The error in durability due to wear and tear must not exceed the absolute value of the maximum tolerated error.6.5.1-6 - Humidity conditions: The product must satisfy relative humidity conditions of 85% at the maximum value of the temperature range.6.5.1-7 - Measuring weight on the rail : It must be possible to measure the weight correctly along the entire length of the rail (curvature,...)6.5.2-1 - Out of range : The product must be able to display the Out of range status calculated from the displayed weight. - Minimum Patient Weight 13 kg - Max : max+ 9e PAR RAPPORT A LA TARE -> TBD6.5.2-2 - Return zero status: The product must be able have the “Zero accuracy” status when the weight displayed is +/- 1/4 e = 25 g.6.5.2-3 - Stability status: The product must be able to inform about the Stability status. TBD.6.5.2-4 - Tilt status: The product must be able to inform about the Tilt status. - Tilt is correct: when the angle of the measuring device is less than TBD. - Tilt not correct: otherwise.6.5.3 Scale Calibration and verification Process 6.5.3-1 - Scale calibration: The product shall be able to do an OIML scale calibration.Calibration will only be done with the Service tool6.5.3-2 - Calibration and safe working load: Calibration must be possible for each Safe working load. Consequently, the “maximum” weight of the first calibration step is the value of the product's safe working load.Note : - 7 SWL = 7 maximum calibration6.5.3-3 - Altitude and latitude of destination : Product shall have the ability to set or retrieve destination altitude and latitude information for use with the OIML scale.Note: - Read on GUI / Service tool - Write with service tool.6.5.3-4 - Gravity constant G : The product must be able to calculate and retrieve (for display) the G constant from destination altitude and latitude and local altitude and latitude. This G constant must be taken into account when calculating the scale's OIML weight. The product must be able to display the G interval.Note: - Compute of G is : G=9,780318*(1+(0,0053024*(SIN(LatitudeDestination*3,1415927/180)*SIN(LatitudeDestination*3,1415927/180)))-(0,0000058*(SIN(2*LatitudeDestination*3,1415927/180)*SIN(2*LatitudeDestination*3,1415927/180))))-0,000003085*LatitudeDestination - Range variation is : [(MaxWeight-Tolérance)*G / MaxWeight;(MaxWeight+Tolérance)*G / MaxWeight] with OIML Tolerance ->1/3 e = 0,033.6.5.3-5 - Scale verification: It must be possible to verify the lift's OIML scale with a scale display weight with a details e (= 100g)Note : Scale verification must be done on a Service Tool and on Hand remote Screen. On Hand remote and Service tool, weight must be easily displayed/switched on User mode or Technician mode.6.5.3-6 - Scale verification date: The product must be able to edit and save the OIML scale verification date.Note : - The tare is subtractive - EN45501 §3.5.3.4 - Delete after :Note : - This will be done on the GUI (read and write) and on the service tool (read and write). - The verification date format is day, month, year.6.5.3-7 - Calibration and verification date: When a calibration is carried out and completed in success, the verification date must be deleted (product = unverified).6.5.3-8 - Calibration Interface: Product shall have the interface to do a calibration.Note : Calibration will be done on Service tool and not on the GUI.6.5.4 Saved Weight 6.5.4-1 - Save Weight process: The product shall be able to save the Displayed Weight. In case of already patient weight saved, the product shall be able to erase previous Weight (and replace it with new weight)Requirements for saving a weight: - Hoist angle must be correct - The weight must be stable - No technical errors on the scale (sensor, communication...) - Weight must be between min and max. Weight out of weighing capacity : Out of range scale (max + 9e or min). While on saving weight screen, the scale shall indicate if the Applied Weight is below the Minimum Patient Weight (13 kg) for the lift.6.5.5 Zero/Tare process 6.5.5-1 - Product and Tare process: The product shall only be able to zero/tare the product Scale when the product is without patient. Repeated operation of a tare device is permitted.6.5.5-2 - Tare process: The product shall be able to tare the OIML Scale.6.5.5-5 - Usage Maximum Tare The product must have a maximum possible tare weight of 40 kg. This information must be included in the user documentation.Requirements for taring: - Hoist angle must be correct - The weight must be stable - No technical errors on the scale (sensor, communication...) - Weight must be between minTare and maxTare.6.5.5-3 - Tare/Zero performance: Whatever the tare, the product must be able to return to zero with the associated tolerance.The deviation back to zero, once the indication has stabilized, after removal of any load that has been held on the instrument for thirty minutes, must not exceed 0.5 e, i.e. 50 g.In addition, after returning to zero from any load greater than Max and immediately switching to the lowest weighing range, the indication near zero must not vary by more than e for the next 5 min.6.5.5-4 - Tare process and maximum value: The effect of any zeroing device must not alter the maximum range of the instrument.The total effect of zeroing devices and the zero hold device must not exceed 4% of the Maximum range (200 kg) -> 8 kg, with the effect of the initial zeroing device not exceeding 20%.We need to be able to hook something to the end of the strap, which must weigh a maximum of 30 Kg (this should allow us to measure up to 500 Kg). For calibration (only the hanging system) Tare/zero values below -30 Kg (< 20% max) are prohibited.Note : - EN45501 §4.5.1 - TODO lien avec le terrain / Service. Comment ils ont l'information ? -> A inclure dans la doc technicien. Impact aussi sur l'indus (choix du dispositif). NMI -> Doc à disposition des vérificateurs - Delete after6.5.5-6 - Zero et tenue du zero Accuracy After zeroing, the influence of the zero deviation on the weighing result must not exceed± 0,25 e = 25g within TBD min.6.5.6.1 Electrical integration 6.5.6.1-1 - Using the scale in the lift: When using the scale, the product must disconnect the charger/any power supply other than the battery.Note: - Specification in accordance with using the lift in battery. -> SSRD44956.5.6.1-2 - Electrical power supply The product must comply with the recommendations for power supply defined in the standard EN45501 §3.9.3 Input voltage must not affect measurement or weight calculationNote : - EN45501 §3.9.3 / A.5.4 - Scale Lift is used only in DC mode (input of the scale)6.5.6.1-3 - Electrical integration: The product must comply electronically with everything in the standard Chapter Appendix B (OIML D11 / IEC 61000-4-4 / IEC 61000-4-2 / IEC 61000-4-5 / IEC 61000-4-6).6.5.6.1-4 - Electronic Scale test : The product must satisfy all applicable tests in appendix B of standard EN45501 (except B 3.7) and EN45501 §5.3.4.Note: - Already included ISO61000-4 (no new test)6.5.6.2 Software integration 6.5.6.2-1 - Initialization : During initialization, there must be no indication or transmission of the weighing result.Note : - EN45501 §5.3.5 - Transmission is done with CAN (particular value while init is not completed).6.5.6.2-2 - Impact of external tools on scale: The Service tool, or any other external tool, must not have any impact on the weight measurement or display.Note : - EN45501 §5.3.6.1 / 5.3.6.2 - Electronical CAN with or without External tool / Weight PDO is not sent with Service Tool.6.5.6.2-3 - Scale software version and identification: The product must be able to give or display the software version of the OIML Scale part.6.5.6.2-4 - Software documentation : Software documentation must be provided to the OIML Notify body, containing all the information required to review the software.Note : - EN45501 §G2.1 - SRS / SDD Software documentation.6.5.6.3 Mechanical integration 6.5.6.3-1 - Mechanical integration The scale module hardware board must be closed.6.5.6.2-5 - Scale and memory Software memory must have sufficient storage capacity for the intended purpose. When saved, the data must include all the information required to recall a previous weighing operation:decimal point(s); unit(s) of measure (can be encoded); identification of stored data a checksum or other signature of the stored data.- No decimal point because saved in g unit on the Memory / unit(s) of measure & identification of stored data describe on the SRS EEPROM- CRC will be done in software on scale memory EEPROM (see SRS)6.5.6.2-6 - OIML Software integration Scheduling and runtime of the measuring process shall not be influenced by not legally relevant software6.5.6.2-7 - Scale Parameter save : The following scale parameters shall be stored in a nonvolatile manner:Saved Weight Calibration parameters Current Zero weight Scale Error Codes6.5.6.2-8 - Scale and date: The date used to memorize the scale records needs to be secure. In case of failure (battery failure, battery level too low ) the user needs to be clearly informed before about a failure of the battery managing the date and hour. The error must be enabled until a new date has been entered.6.5.6.2-9 - Software and IEC 62304 The software must be compatible and tested in accordance with IEC 62304 (tests and associated documentation).6.5.6.3-2 - Seal between load cell and support: The mechanical attachment of the load cell (screw) to its support must be protected by a seal.6.5.6.4 Failures 6.5.6.4-1 - Failures on scale: The product must be able to report potential errors on the scale (reported on a screen or on a technician's tool). TBD6.5.6.4-2 - Failure scale and weight When a significant fault has been detected (a scale error), the scale functionality must shut down and no longer display weights. As long as the error is active, it should be visible to the user when he/she tries to use the scale.6.5.6.5 Security Scale 6.5.6.5-1 - Security scale for intrusion or modification:The product must have means of protection on the components. The product's software must include this protection (software protection), with the possibility of winding up an intrusion counter, or an intrusion test (available with a technician tool). This applies to:calibration commands (calibration coef + factory zero) done or attempt altitude or latitude adjustment (destination) any software update. Scale memory eraseThe product must maintain a history of any intrusion.6.5.6.5-2 - Installation of seals : The product must not have replaced load cells without breaking the seal. The product must be sealed for any access to or modification of the load cells.6.5.6.5-3 - Data protection: Transmission or storage of patient weight data must be protected against accidental or intentional modification. When saving, a checksum must be applied to the memory write.Note : - EN45501 §5.5.3.3 - On software : CRC on memory + CRC CAN.6.5.6.5-4 - Software security: The scale software must be protected against external (pirate) updates. If this is not the case, the scale software must not be able to start if the code is falsified (CRC fail).Note : - EN45501 §G2.2.2 - Le logiciel au niveau cybersécurité sera testé régulièrement (timing défini dans le SPMP...) - Software impact: use of CRC on LCB Software, Cybersecurity for LCM Software. SRS on version consistency between LCB and LCM and error generation otherwise.6.5.6.5-5 - Confidential data: The product must never, without being secured, record a weight associated with a patient ID.Note : - Software impact: In LCB no patient identifier / On the LCM side, always cyber security (no memory reading). - WELMEC 7.2 / 8.2 T56.5.7-1 - Creep test The product must be able to withstand a creep test as specified in Annex A EN45501 §Annex A A.4.11.1.Note : - EN45501 §Annex A - Test done on development.6.5.7-2 - Standard Weight for verification: Standard weights or masses used for type examination or verification of an instrument must comply with the metrological requirements of OIML Recommendation R 111Note : - EN45501 §3.7 - EN45501 §Annex A6.5.7-3 - Ramp up/down test and weighing test: The product must undergo a ramp up/down test. The error close to the maximum range must not exceed the maximum tolerated error, and the absolute value of the difference between the errors obtained for all the measurements taken in pairs must not exceed the greater of half the verification scale interval or half the absolute value of the maximum tolerated error.Note : - EN45501 §5.3.3 and 5.4.2 - OIML R76-1 A.4.4 / A.4.6 - EN45501 §Annex A - Test done on production, development and on field.6.5.7-4 - Repeatability : The product must be able to measure the same mass several times (5 times) and each time the value must be consistent. The measurement must be close to 80% of the maximum. You must wait for the return to zero between measurements without saving the value. The max values will be saved (not the return to zero values).Note : - EN45501 §3.6 - EN45501 §Annex A - OIML R76-1 A.4.10 / R76-1 3.6.16.5.7-5 - Zeroing accuracy test The product must be able to do Zeroing accuracy testNote: - OIML R76-1 A4.2.3 - EN45501 §Annex A - Test done on production, development and on field.6.5.7-6 - Scale indication limit test: The product must be able to do Zeroing accuracy test6.5.7-7 - Tare Accuracy Test The product must be able to do test a Tare Accuracy TestNote: - OIML R76-1 A.4.6.2 / R76-2 §9 - EN45501 §Annex A - Test done on production, development and on field6.5.8.1 Continous weight 6.5.8.1-1 - Continous weight display : The primary user control Integrated Scale user interface shall display a continuously-updating weight measurement.- Any decimal part must be separated from the corresponding integer part by a decimal comma, with one digit to the left of the decimal point and all digits to the right. - The decimal point must be aligned with the bottom of the digits (e.g. 0,3 kg). - On an analog indicating device, the zones on either side of zero must be distinguished by the “” (in case f positive value) and “-” signs. Minimum Displayed Scale Value: indication below zero with minus sign possible when a tare device is in operation.6.5.8.1-3 - Increment display : The primary user control EN45501 Integrated Scale user interface shall display weight in increments of 0.1 kg by default.Max value: Indication must be made impossible above Max + 9 e. Min value : An indication below zero (with minus sign) is possible when the tare device is active and the tare load has been removed from the load receptor. It is also possible for negative values of up to -20 d = -2 kg may be displayed, even if the tare device is not active. TBDNote : - The values above the Maximum Scale Capacity are for margin and to ease testing - Reference EN45501 § 4.2.3 Limits of Indication for 0,9 kg. It is based on 9e where e is the verification scale interval. The value of e is given in the EN45501 scale section of this document. - Note: Reference EN45501 Limits of Indication6.5.8.1-5 - Unit: The scale user interface shall display the units (kg) of measurement for weight displayed on the GUI (EN45501 §2.1). The product must also be able to display the weight in Pounds while retaining the weight in kg (configured by user configuration).Note : Configuration to have or no pounds is done thanks to the Service tool and configuration file.6.5.8.1-6 - Weight display limitation: The product shall be able to display the weight only if Lift is in Recommended Lift Position: - Hoist angle must be correct -> See ELV-4279 - No technical errors on the scale (sensor, communication, beam failure...) - Weight must be between min and max. -> See ELV-4280The scale shall display a message "---,-" instead of a weight if the product is unable to measure or display the Weight6.5.8.2-1 - Display normative information The following markings shall be displayed either on or near the EN45501 scale user interface exactly as shown below when the continuously updated scale is displayed:Note : - For min and max, spaces before and after the '=' may be removed. - No additional symbols can be added after any of the markings including ' = ' and ' : '. - Reference EN45501 Presentation of descriptive markings6.5.8.2-2 - G Display The product shall display the value of G computed and G interval (on user access).Note : - See SSRD 4345 about G compute.6.5.8.3 Display status 6.5.8.3-1 - Zero indicator status The product shall display the zero indicator with this symbol (>0<). (See ELV-4281 - Return zero status: The product must be able have the “Zero accuracy” status whe...)6.5.8.3-2 - Equilibrium status: The product shall display Stable Equilibrium status. The product must be able to display if the scale is stabilized or no (See ELV-4873 - Stability status: The product must be able to inform about the Stability status.... ).6.5.8.4 Patient Weight saved process Display 6.5.8.4-1 - Display the saved weight : The product shall display the most recent saved weight.6.5.8.4-2 - Display saved weight process : Display Weight saved function: During the Saved Weight function the user interface shall include the following features:· Visual message or image telling user to not touch the product. The user control Integrated Scale interface shall provide a visual indication when weight saving is in process, including a "hands off" instruction.· Product waits the weight stability (see ELV-4873)audible indicator that a weight has been measured and saved Display of saved weight Time & date of the saved weightProblem to save weight: In case of issue to saved weight, product must abort the saved weight process.6.5.8.4-3 - Stability status: The product must be able to display the Stability status.6.5.8.6 Technicien Scale oiml Display: 6.5.8.6-1 - Technician scale OIML Display : Product shall have the display for technician:6.5.8.4-4 - Display when weight cannot be displayed or measured. The product must display information when the weight cannot be displayed or measured with an error message indicating the cause.· In case of no stability (See ELV-4873) during more X s (timeout), the user control Integrated Scale interface shall provide a visual indication that stability is not correct to saved weight.· In case of hoist angle is not correct, the user control Integrated Scale interface shall provide a visual indication that angle is not correct to display or saved weight.(see ELV-4279)· In case of technical scale fealure (due to sensor, communication...), the user control Integrated Scale interface shall provide a visual indication that scale is on error to display or saved weight.· In case of scale is out of range, the user control Integrated Scale interface shall provide a visual indication that scale is out of range to display or saved weight. (see ELV-4280)6.5.8.5 Tare process Display: 6.5.8.5-1 - Display Tare process : Message Before : Before Zero the product, the user interface shall provide an information like: - "The lift must not be occupied to perform zeroing", - "Place all standard element before zeroing the lift", - "Verify lift is with correct sling bar" AND request confirmation before zeroing the product,Message during tare proces : Visual message or image telling user to not touch the product. The user control Integrated Scale interface shall provide a visual indication when tare is in process, including a "hands off" instruction. Product waits the weight stability (see ELV-4873).Message after tare: When stability is ok, Tare process is done on the scale module. The user interface shall provide an information like tare is done: Scale Zeroed/TaredDisplay problem to tare (see SSRD 4958): In case of issue (stability timeout, scale failure, angle or range) to tare, product must abort the tare process and display the cause.Note : Tare / Zero. Quel mot ?6.5.8.5-2 - Zeroing and Tare : Product tare and zero are combined. The product must show the “0/T” symbol.Altitude and latitude of destination (GUI: read / Interface Service tool: read & write) Altitude and latitude of local (GUI: read / Interface Service tool: read & write) G computed and G interval (GUI: read / Interface Service tool: read ) Current Weight computed with Technician mode (see OIML scale) and User mode (GUI: read / Interface Service tool: read) Possibility to read/write OIML verification date (GUI: read & write / Interface Service tool: read & write)6.6.1 General power operation of the Hoist 6.6.1-1 - When battery charges on In-Rail Charging or End of Rail battery chargers, the electrical function (High_Low, Emergency lowering, electrical movements or function display on user control) or/& lateral movement of the Hoist shall:3. Stop the battery charge to prevent to draw current from any connected charging power supply Use the battery power to perform the movement Permit associated electrical movement6.6.1-2 - When battery charges through Hand Control chargers, the electrical function (High_Low, Emergency lowering, electrical movements or function display on user control) of the Hoist shall:3. Stop the battery charge to prevent to draw current from any connected charging power supply Use the battery power to perform the movement Permit associated electrical movement6.6.1-3 - While there is battery charged, the Hoist shall remain operational in the event:3. Loss of AC mains power Interruption of AC mains power Restoration of AC mains power6.6.1-4 - The Emergency Stop activation or reset shall cause no interruption to charging of the Hoist.6.6.2 Charging systems 6.6.2-1 - Where charged through the End of rail or Hand Control, the interface between the battery and power supply shall integrate 10 (TBC) connections/disconnections min per day combined with 3 years of use without impact on battery performance (cycle numbers ELV-1651 & SOH of 80% min (TBC)).6.6.2.1 In-Rail charging system 6.6.2.1-1 - The battery of the Hoist shall integrate the possibility to be charged by In-Rail Charging System.6.6.2.1-2 - When charged by In-Rail Charging System, the battery of the Hoist shall charge from 0 % to 100 % in 16 hours max.6.6.2.2 Hand Control charging system 6.6.2.2-1 - The Hoist battery shall integrate the possibility to be charged through the Hand Control.6.6.2.2-2 - When charged through the Hand Control, the battery of the Hoist shall charge from 0 % to 100 % in 6 hours max.6.6.2.3 End of Rail charging system 6.6.2.3-1 - The Hoist battery shall integrate the possibility to be charged by the Multi-station through the Hoist Multi-connector.6.6.2.3-2 - When charged by the End of Rail charging station, the battery of the Hoist shall charge from 0 % to 100 % in 6 hours max.6.6.3.1 Power modes 6.6.3.1-1 - To save power consumption, the Hoist shall have Power Modes:ELV-4765 - Off Power Mode ELV-4770 - In-Charge Power Mode ELV-4769 - Standard Power Mode ELV-4767 - Light Power Mode ELV-4768 - Sleep Power Mode6.6.3.1.1 Behavior in Off Power Mode 6.6.3.1.1-1 - While in ELV-4765 - Off Power Mode, the Hoist shall disable the following features:6.6.3.1.2 Behavior in In-Charge Power Mode 6.6.3.1.2-1 - When in ELV-4770 - In-Charge Power Mode, the Hoist shall enable the following features with their own management:6.6.3.1.3 Behavior in Standard Power Mode 6.6.3.1.3-1 - When in ELV-4769 - Standard Power Mode, the Hoist shall enable all features with their own management:6.6.3.1.4 Behavior in Light Power Mode 6.6.3.1.4-1 - When in ELV-4767 - Light Power Mode, the Hoist shall disable the following features:7. SCRM connectivity feature is enabled but shall reduce its activity6.6.3.1.5 Behavior in Sleep Power Mode 6.6.3.1.5-1 - The Hoist, when in ELV-4768 - Sleep Power Mode, shall disable the following features:6.6.3.2 Power mode transitions 6.6.3.2-1 - Excepted for ELV-5032, the Hoist shall transition between power modes in less than 1.5s (TBC).6.6.3.2-2 - While in ELV-4769 - Standard Power Mode, ELV-4767 - Light Power Mode or ELV-4768 - Sleep Power Mode, when a charging power is available via the ELV-2436 - Hand Control Charging System and when there is no ELV-4784 - User Request, the Hoist shall transition to ELV-4770 - In-Charge Power Mode.6.6.3.2-3 - While in ELV-4769 - Standard Power Mode, ELV-4767 - Light Power Mode or ELV-4768 - Sleep Power Mode, when a charging power is available via the ELV-2438 - Multi Station Charging System and when there is no ELV-4784 - User Request, the Hoist shall transition to ELV-4770 - In-Charge Power Mode.VC: I feel like a Lateral Movement should stop the battery charge (to protect the electrical contacts from sparks damage) but not make the system switch to Standard Power Mode or prevent it from switching to In-Charge Power Mode.6.6.3.2-4 - While in ELV-4769 - Standard Power Mode, ELV-4767 - Light Power Mode or ELV-4768 - Sleep Power Mode, when a charging power is available via the ELV-1073 - In-Rail Charging System and when there is no ELV-4784 - User Request for more than 5 min, the Hoist shall transition to ELV-4770 - In-Charge Power Mode.VC: I feel like a Lateral Movement should stop the battery charge (to protect the electrical contacts from sparks damage) but not make the system switch to Standard Power Mode or prevent it from switching to In-Charge Power Mode.6.6.3.2-5 - While in ELV-4770 - In-Charge Power Mode, when there is a ELV-4784 - User Request or when the charging ower is disconnected, the Hoist shall transition to ELV-4769 - Standard Power Mode.VC: Since Lateral Movement only interrupts the battery charging in IRC or EOR systems, there is no need to switch to Standard Power Mode.6.6.3.2-6 - While in ELV-4767 - Light Power Mode or ELV-4768 - Sleep Power Mode, when there is a ELV-4784 - User Request or Lateral Movement, the Hoist, out of the user control display of the Hoist defined by NPD51278 ELV-5034, shall transition to ELV-4769 - Standard Power Mode in less than 1 second (TBC).6.6.3.2-7 - While in ELV-4769 - Standard Power Mode, when there is no ELV-4784 - User Request or ELV-843 - Lateral Movement for more than 10 min, the Hoist shall transition to ELV-4767 - Light Power Mode.6.6.3.2-8 - While in ELV-4767 - Light Power Mode, when there is no ELV-4784 - User Request or ELV-843 - Lateral Movement for more than 24h, the Hoist shall transition to ELV-4768 - Sleep Power Mode.6.6.3.2-9 - While in ELV-4770 - In-Charge Power Mode or ELV-4769 - Standard Power Mode, when the battery ELV-4792 - State of Charge (SoC) drops below 2% (TBC) or when a specific message from technician tool is received, the Hoist shall transition to ELV-4765 - Off Power Mode.VC: Can the electronic/software systems swap to Off Mode even if a power source is connected ?6.6.3.2-10 - While in ELV-4767 - Light Power Mode or ELV-4768 - Sleep Power Mode, when the battery ELV-4792 - State of Charge (SoC) drops below 2%, the Hoist shall transition to ELV-4765 - Off Power Mode.6.6.3.2-11 - While in ELV-4765 - Off Power Mode, when a charging power is detected, the Hoist shall transition to ELV-4770 - In-Charge Power Mode and initiates its startup sequence.6.6.4-1 - Following the "Cycle of ELV-4054", battery 100 % charged, with an State of Health (SOH) level of 80 %, per Max Load configuration & for each specific single load cases, the Hoist shall guarantee in min: (to change the value of the spreadsheet below, used the excel file in attachement into ELV-4054)6.6.4-2 - The battery charge shall manage 3 years of charge/discharge without impact on battery performance (cycle numbers following ELV-1651 & SOH of 80% min (TBC)).6.6.4-3 - The Hoist shall calculate the State of Health (SOH) % of the battery i.e. the ratio of real battery capacity / the initial battery capacity.6.6.4-4 - The Hoist shall provide information of the SOH in a specific menu only accessible by service technician.6.6.4-5 - After 24 months of storage, the battery of the Hoist shall guarantee a degradation of its max capacity less or equal than 20 %.VC: max capacity means SOH ? The battery manufacturer states that a battery becomes unusable when SOH goes below 80%, so this spec means the battery must be replaced after 2 years of storage, that's a bit strange.6.6.4-6 - After 24 months of storage, the Hoist battery shall always be rechargeable.6.6.5 Battery levels 6.6.5-1 - The Hoist shall transition to Full battery level when the ELV-4792 - State of Charge (SoC) is above 90%.6.6.5-2 - The Hoist shall transition to High battery level when the ELV-4792 - State of Charge (SoC) is between 50% and 90%.VC: Je n'ai pas compris le point 2 (formulation à changer pour être plus clair ?)6.6.5-3 - The Hoist shall transition to Medium battery level when the ELV-4792 - State of Charge (SoC) is between 50% and 30 % allowing 50 % of the cycle number defined by ELV-1651.6.6.5-4 - When battery charge level shall only achieve 1 complete way up/way down cycle with the max load, the Hoist shall transition to Low battery level.6.6.5-5 - When the remaining battery capacity is lower than 1 complete way up/way down cycle with the max load (ELV-4776), the Hoist shall transition to Empty battery level.6.6.6.1 To Dynamic Rails 6.6.6.1-1 - The battery of the Hoist, through multi-Connector, shall supply power to the motor of dynamic rails (turntable, switch).6.6.6.1-2 - Exclusively when an electric dynamic rails user request is request, the Hoist shall supply power to the multi-connector.6.6.6.1-3 - Where the hoist integrated a multi-connector, when the Hoist powered an electric dynamic rails (turn table or switch rail), the electrical movement of the dynamic rails shall be triggered if and only if the carriage of the Hoist is fully engaged on the fix part of the dynamic rail to avoid shear point.6.6.6.2 To Transfer Motor 6.6.6.2-1 - The Hoist shall provide an interface to supply power to a motorized transfer motor.6.6.7 Safety characteristic of the battery 6.6.7-1 - The battery of the Hoist shall have an internal protection that works independently of the electronic of the lift if battery is exposed to a critical conditions i.e.:1. A cannot charge situation due to its low level of charge6.6.7-2 - When dropped from a installation height (see explanation into the context) & table height defined by IEC 62133-2 §7.3.3, the Hoist with the battery shall be protected from leakage or fire hazard to prevent explosion.6.6.7-3 - When dropped from a installation height (see explanation into the context) & table height defined by IEC 62133-2 §7.3.3, the battery installation shall prevent leakage or fire hazard to prevent explosion.6.6.7-4 - The Lift Control Board shall be protected:1. charge the battery with 1 charging system at the time2. provide the remaining duration to to have a 100% of the battery charged.6.6.7-6 - The Hoist shall charge the battery if the intended power supply is detected and no electrical movement engaged.6.6.8 Battery user Feedbacks 6.6.8-1 - The Hoist shall provide a power related visual feedback for:Battery In_charge mode Battery charge level Low battery Empty battery Defective battery (see §6.8.1 error management)VC: Seulement pour la télécommande écran ? Si oui, à préciser. Si non, certaines info ne peuvent pas être affichées (ou pas prévues pour l'instant) sur la télécommande membrane.6.7 Maintain the product 6.7-1 - When a software update event pushed to the Hoist, the Hoist shall download software updates if and only if battery has at least 25% capacity remaining (TBC).6.7.7.1 Software update 6.7.7.1-1 - Software update The product shall be able to update product software with a technician tool, either wired or wireless when permitted by the product configuration.6.7.8.1 General requirement 6.7.8.1-1 - Enable/Disable SCRM option: The product provides a possibility to enable or disable the Remote Service feature. The Remote Service feature is disabled by default.Note: - Settings on the customer configuration fileHypothese: no impact when Product ID != Certificat6.7.8.2-1 - Server connection: When the Remote Service feature is enabled SCRM , the product shall connect securely to the Remote Service server.Tenant Information (from Customer configuration file) with Certificate Organization Name (from Customer configuration file) Facility Name (from Customer configuration file)6.7.8.2-2 - Secure communication with Server : The device shall be capable of communicating securely with an trusted remote server using TLS 1.2 with 256-bit encryption as a minimum.6.7.8.2-3 - Server disconnection/reconnection: The device, with [AEWD] connection lost (see note), shall have a recovery process to automatically reconnect the [AEWD] as soon as the connection failure is solved. The product shall attempt disconnection/reconnection when the product loose the Remote Service Server during more TBD minutes.1) Lost of Server connection can be because of Device failure or Server failure,6.7.8.2-4 - Secure communication : The product shall support installation of EAP-TLS client certificates and CA certificate through local and remote interfaces. The SOM shall support updating of existing EAP-TLS client certificates and CA certificates through local and remote interfaces.Note: - Certificate update with Service Tool or SCRM.6.7.8.3.1 Software update 6.7.8.3.1-1 - Update software: The product shall be able to update product software from SCRM request with/without last manual technician step (TBD)6.7.8.3.1-2 - Update software process: When commanded by the Remote Service Server and the product is not processing a SW update, the product shall download the software package.When the product is processing a SW update, and the product receives a command to update from the Remote Service Server, the product shall:2. send a rejection message to the Remote Service Server corresponding to the latest SW update request.When commanded by the Remote Service Server AND the SOM is not processing a SW update, the SOM shall send a downloading message to Remote Service ServerWhen the product detects an error in the downloaded software package, the product shall retry attempt to download up to 5 times.6.7.8.3.1-3 - Update communication verification: When the product downloads the software package, the product shall perform a verification of the downloaded software package.6.7.8.3.1-4 - When the SOM fails to download the software package 5 times, the SOM shall send a download failure message to Remote Service Server.6.7.8.3.1-5 - When the SOM detects an uncorrupted software package, the SOM shall send a Staging message to Remote Service Server.6.7.8.3.1-6 - The SOM shall initiate distributing the SW package to the boards upto 3 times when:2. SOM determines that received SW package is not corrupted.6.7.8.3.1-7 - The SOM shall continue the SW package to the boards available on bed battery power when:6.7.8.3.1-8 - When the staging of the firmware to a board is interrupted by a power loss of the SOM, the SOM shall re-stage the firmware for the impacted board for upto 3 times, when SOM recovers from power loss.6.7.8.3.1-9 - When the SOM fails to stage a board for 3 times the SOM shall send a message to Remote Service Server.6.7.8.3.1-10 - When the MCB determines that the staging is consistent, the MCB shall attempt toggling the boards upto 3 times, under the following conditions:6.7.8.3.1-15 - When the MCB receives a loading failure message from the SideCom micro controller, the MCB shall6.7.8.3.1-16 - When MCB receives a successful toggle message AND the software update is pending, the MCB shall send a message to FUD to display a visual indicator on2. settings screen suggeting the software update is pending.6.7.8.3.1-17 - The Remote Service OS Update process on the SOM shall have a demonstrated reliability of 99% with 90% Confidence.6.7.8.3.2-1 - Configuration update with SCRM: The product shall be able to change the customer configuration from SCRM request.6.7.8.3.1-18 - When the MCB determines that the Firmware update initiated by the Remote Service is upgraded to the bed, the MCB shall send a message to SOM to inform Firmware Update success to the Remote Server.6.7.8.3.1-19 - After the bed restarts to complete the firmware update process, if the SOM succeeds in upgrading itself to the staged SOM application software, the SOM shall send a Firmware Update success message to the Remote Server.6.7.8.3.1-20 - After the bed restarts to complete the firmware update process, if the SOM fails to upgrade itself to the staged SOM application software, the SOM shall send a Firmware Update Failure message to the Remote Server6.7.8.3.1-21 - The SOM shall support encrypted firmware package for remote upgrade.Note: A customer configuration is an encrypted file, created with Service tool to configure:Display configuration (default language, date/time format, technician password, time zone used Scale configuration (unit ? Hide patient weight ?.. Mobility score format (next release) Connectivity profile (SSID, Password.. SCRM and BDHP (next release) parameter Many others configuration (reminder for maintenance expiration, patient name HIPPAA encryptedThis configuration file can be edited once and then sent to the entire product fleet6.7.8.3.3-1 - The product shall be able to send log file to SCRM Server. Log files could be used for all history requests6.7.8.3.3-2 - When the SOM receives a fetch log message from the Remote service, the SOM shall send the SOM logs to RemoteService.6.7.8.3.4 Data 6.7.8.3.4-1 - When the SOM contains a stored Remote Service External ID AND the SOM establishes connection with Remote Service, the SOM shall send the following data to the Remote Service:6.7.8.3.4-2 - When the SOM receives an Active_Error_Code, the SOM shall initiate an Inhibit Timer with a resolution of 5s for the detected Active_Error_Code. When the bed powers UP AND SOM receives an Active_Error_Code, the SOM shall initiate an Inhibit Timer with a resolution of 5s for the detected Active_Error_Code.6.7.8.3.4-3 - When a Status_Change occurs on the Service_Required_Status, AND the SOM contains the stored Remote Service External ID, the SOM shall send the Service_Required_Status to Remote Service Server.6.7.8.3.4-4 - When a Status_Change occurs on the Firmware_Version, AND the SOM contains the stored Remote Service External ID, the SOM shall send the Firmware_Version to Remote Service Server. When a Status_Change occurs on the Software_List AND the SOM contains the stored Remote Service External ID, the SOM shall send the Software_List to Remote Service Server.6.7.8.3.4-5 - When a Status_Change occurs on the Patient Presence AND the SOM contains the stored Remote Service External ID, the SOM shall send the Patient Presence to Remote Service Server.6.7.8.3.4-6 - When a MQTT_Config command is received from the Remote Service Server, the SOM shall create an MQTT profile. When a WiFi_Config command is received from the Remote Service Server, the SOM shall create an WiFI profile6.7.8.3.4-7 - The SOM shall send a heatbeat to the Remote Service Server every 5 +/- 1 min.6.7.8.3.4-8 - The MCB shall send the Remote Service message time stamp to be displayed on the Remote Service Credentialed_Service_User interface of the FUD in the following format:6.7.8.3.4-9 - Link with ICD Data: If data points supported by the device, the data supplied by the wireless module, including exception values if applicable, shall comply with “NPD35311 Device Data Dictionary for MQTT Protocol” to support HR Digital Health Gateway system.6.7.8.3.4-10 - Timeout data transmission: For all data streaming on MQTT, when their status change, streamed on MQTT in less than 3 seconds, the BDHP gateway shall be able to timestamp (date/hours/minutes/seconds) this data.6.7.8.3.4-11 - Maintenance date: For Preventive maintenance, the device shall be able to transmit, in less than 3 seconds after a change occur to Approved External Wireless Device [AEWD]:6.7.8.3.4-12 - Data connection to server: The lift sends data to SCRM to find out how it will connect (Thin-edge), and which operations are supported. (download configuration file, softa update, log recovery...). The lift sends data to SCRM to monitor the state of the wifinetwork and its use (between the lift and SCRM):Product IP address MAC address (product), Access Point used RSSI (signal strength) SSID (Wi-Fi profile used, on which network)...6.7.8.3.4-16 - Product version The product shall be able to sent this product version to SCRM:6.7.8.3.4-13 - Device Logs The product shall be able to sent Device log from SCRM request. Product log could be:Debug log file Maintenance date and history Connectivity history Scale access Failure history and occurence6.7.8.3.4-14 - Failure Logs The product shall be able to sent current active failure to SCRM in order to view alert and information for error code.6.7.8.3.4-15 - Product data The product shall be able to sent this product data to SCRM:Overweight status + count Emergency Status + count Last patient weight saved + count Status of power state [Charging, normal use, standby, standby deep, critical battery] Status of the battery: Battery Health, type of battery, capacity, voltage… No possibility to have all data (topic with Electronic team to have this data)Software revision Product identification (Model name and Serial Number) Detail list of software version6.7.8.3.4-17 - Detail usage data: The product shall be able to sent this detailed usage to SCRM: Data : Last Lift activity [Date / up_in_charge (cm), down un charge (cm); up empty (cm), down empty (cm), horizontal (m) / declared activity]. In this case, we save a complete movement6.7.8.3.4-18 - Location The product shall be able to sent this location to SCRM:Static localization (Service Tool) Dynamic localization (AP localization)6.7.8.3.5-1 - Configuration The product shall be able to be configured with configuration file and external technician serviceWhen decrypting Wi-Fi credentials for use, the product shall only store the decrypted credentials in volatile memoryNote: - A part of encrypt key is on LCB module, others are on LCM module.6.7.8.3.5-3 - Update SCRM Configuration: When the product receives an update to the existing SCRM profile over the local and remote interfaces, the product shall store the update in persistent memory6.7.8.4 Link with User interface 6.7.8.4-1 - Each time a Wireless process (connection, wait for gateway response), has been engaged between the device and HR Gateway, needs a waiting period to be completed, the device shall display "a living information" to inform user that a process is in progress ELSE the display of "a living information" shall stop as soon as the process is ended.6.7.8.4-2 - The product shall have an interface to ON or OFF (power down WIFI radio emission) the WIFI module AND provide associated visual feed-back.Note: - OFF/ON interface based on recommendations 1999/519/EC, Wi-Fi network ANSSI No DAT-NT-005/ANSSI/SDE/NP (Anses n° 2012-SA-009), - OFF meaning power down WIFI radio emission. - By default, the WiFi shall be OFF.6.8.1 Wireless Communication (If Option available) 6.8.1-1 - Even if the product is connected through its Wireless function to an Approved External Wireless Device, it shall continue to provide all local alerts through the defined visual and audible indicators.6.8.2 Wireless module of the device 6.8.2-1 - With a 802.11 compliant wireless access point transmitting 25mW at 2.4Ghz or at 5Ghz, with patient on the device, with device in worst case position (see note) i.e. preventing as much as possible the diffusion of the WiFi signal (bell effect), the device shall measure a receive level, i.e. record the receive signal strength at the WiFi module antenna, of at least -65 dBm at a line-of-sight distance of:· 16 m from the transmitter in free space and at any angle for 2.4 Ghz,· 8 m from the transmitter in free space and at any angle for 5 Ghz.Note: - Worst case condition for a bed is in flat and in low position. - Calculation of 8 meters for 5 Ghz FrequencyDistance In free transmission a radio wave is naturally attenuated according to the distance that separates it from its transmitter. This attenuation is proportional to the square of the distance. Each time the distance doubles, the signal is divided by 4 which corresponds to an attenuation of 6 dB. Example: for a distance of 50 m the attenuation is 74 dB, it increases to 80 dB for 100 m.Frequency The higher the frequency, the greater the attenuation. Here again, the damping will be proportional to the square of the frequency. For the same transmission power, a frequency twice as high therefore implies a signal 4 times weaker (6 dB gap between 2.4 GHz and 5 GHz). However, the higher the frequency, the higher the achievable throughput.Calculation For 2,4 Ghz / 16 m / -65 dBm For 5 Ghz / 16 m / -71 dBm For 5 Ghz / 8 m / -65 dBm6.8.2-2 - Device on AC power, with patient on the device, with all electrical features of the device operating, with device in worst case position (see note) i.e. preventing as much as possible the diffusion of the WiFi signal (bell effect) as a starting position, the signal-to-noise ratio (SNR) at the the WiFi module antenna shall be at 15 dB at minimum during all operating mode.Note: Worst case condition for a bed is in flat and in low position.6.8.2-3 - To protect the device from attacker, the WiFi chipset shall be located in an enclosure with a cover attached to force to have a tool to access it.6.8.2-4 - On Main power, in case of WiFi module failure, the product shall log the error and inform the user6.8.3 General WiFi characteristics to interface the Gateway 6.8.3-1 - The Wireless communication of the WiFi Connected Product to the Approved External Wireless Device [AEWD] shall be compatible with IEEE 802.11 a/b/g/n.6.8.3-2 - The product shall have the possibility to retrieve network time to update the product.6.8.3-3 - FIPS: The SOM shall store any Wi-Fi credentials with a FIPS 140-2 compliant encryption6.9.1-1 - Where the hoist equipped with [Membrane] user control, when activated, the Hoist shall display a status of:1. Weight overload & Exceeded Max reach angle6.9.1-2 - Where the Hoist equipped with [GUI] user control, when there are actives, the Hoist shall display explanation of:6.9.1-3 - The Hoist enclosure shall display a Red, Safety Yellow and Green indication relative to the Hoist "ready to use" status (see ELV-1786 - When The Hoist is wake up, its "ready to use" status shall: * switch on 1 of its... ):3. User in standup position, visible at a distance of 10 m around the Hoist enclosure, With least ambient illuminance favorable level in the range of 100 lx to 1 500 lx The observer having a visual acuity of 0 on the log min Angle of Resolution (log MAR) scale or 6/6 (20/20) corrected.Can we say the Hoist display a "visual/light/colored indication" instead of re-stating the specific colors green/yellow/red that are already defined in ELV-1786 ?6.9.1-4 - When The Hoist is wake up, its "ready to use" status shall:1. switch on 1 of its 3 colors (ELV-3178 - The Hoist enclosure shall display a Red, Safety Yellow and Green indication rela... ) within 1.1 sec of detection2. following "display priority" specify in table just below3. following trigger specify in table just belowReady to use Feed-back in case of wrong usageReady to use Feed-back in case of Hoist failureBattery charging mode: Blink passing through a dim display at 0,2 HzWhen the battery is in charging mode, while the battery level is under X % (TBC - see § Battery management)NA and Full battery level (ELV-4773) & High battery level (ELV-4774)When the battery is in charging mode, while the battery level is under X % (TBC - see § Battery management) NA4) Empty battery level (ELV-4777) 4) Exceeded Hoist strap angle (ELV-2009, ELV-2010, ELV-3049)When the battery is in charging mode, while the battery level is under low battery level (TBC - see § Battery management) Display Priority 1 In case of critical failure defined by ELV-3324 and ELV-31426.9.1-5 - The ready to use fonction of the Hoist shall switch on in case of :3. Key press of the Hoist user control A Hoist movement Hoist status change defined by ELV-1786 - When The Hoist is wake up, its "ready to use" status shall: * switch on 1 of its... between "Red" "Safety Yellow" "Green" displays.6.9.1-6 - While the Hoist is not in power saving mode, the ready to use function shall stay ON.Link to Power modes definitions (par. 6.6) when properly defined.6.9.1-7 - The Hoist shall produce a usage audible indicator (specify by ELV-3222 - The usage audible feedback shall be chime type i.e.: Frequency: La - 600 Hz - 0.... ) for:a.1 Upward Movement requested whereas weight overload triggered a.2 Upward Movement requested whereas lift motor over usage protection triggered a.3 Upward Movement requested whereas vertical upper stop reachedb.1 Lower movement requested whereas vertical lower stop reachedd.1 Movements requested whereas Exceeded max reach angle of the strap or twist of the strap (ELV-2009, ELV-2010, ELV-3049, ELV-1326)e.1 Movements requested whereas the "Low battery capacity" detected (ELV-4776) f.1 Movements requested whereas the "Empty battery" detected (ELV-4777)7 Labeling 7-1 - The Hoist shall have a label with:9. Class II mark for protection against electric shock7-2 - The Hoist shall be marked with Unique Device Identifier (UDI) in accordance with GS1 Data Matrix format as specified in FDA UDI Guidance documents #691-1 and 89-4203.7-3 - The Hoist shall be marked with:1. the min load in kg and lbs unit2. the max load in kg and lbs unit7.1 Label relative to battery function 7.1-1 - The part of the Hoist intended to deliver power shall be marked with the following information when applicable:7.1-2 - The battery location shall have a label visible when the user access with the following information:7. Battery type Battery feature Caution: "Only qualified Service Personnel to change the Battery" Mode of insertion of the battery Warning sign indicating the Hazard if applicable Warn not use different batteries else risk of result in a HAZARD of high temperatures, fire or explosion The life duration.7.1-3 - The battery access cover shall be protected by a seal label.7.1-4 - The Over-voltage, Over-current and Short-circuit protection shall have a characteristics label on the Lift Control Board near from their location.8.6.1 Calibration 8.6.1-1 - When the Hoist requires calibration process, the calibration event shall be timestamped.8.6.1-2 - Using the service menu, the Hoist shall permit the calibration of high/low movement to guarantee these criteria:8.6.2 General Error Management 8.6.2-1 - The Hoist shall store the failures information replacing the oldest code with a newly created code on a sliding window of 70 values.8.6.2-2 - The Hoist shall log failures to support 2 ways to display i.e.:1. Triggered hour & date of active status - Failure Code - Active/Non Active2. Trigger hour & date of non-active status - Failure Code - Active/Non ActiveB) Occurrence historical of error code per error code with the information:1. Triggered hour & date - Disappeared hour & date (if available) - Critical/Non-Critical - Failure Code - Active/Non-Active - Number of occurrence per failur8.6.2-3 - The hoist shall handle the following breakdowns:8.6.2-4 - When the failure is no more active, the Hoist shall update the user visual and audible feed-back accordingly.8.6.2.1 Error management - users feedbacks 8.6.2.1-1 - The primary user control shall display or remove an error within 1.1 sec of detection.8.6.2.1-2 - When an error activates, the Hoist shall generate a user feed-back i.e.:a. Switch on failure indicator on user controlb. Where a Graphical Unit Interface available, display a pop-up:1. With date & hour when error generates2. With failure code & active/non active statusc. While the error activates, when the error triggers & when the function relative to the failure used (see ELV-3324), generate an audible feed-back (see ELV-3223).3. For critical failure (ELV-3324): While the error activates, when the error triggers and when the Hoist is wake-up, switch on the red light of "Ready to Use" at a frequency of 1000 Hz (TBC) for 30 seconds.8.6.2.1-3 - Where Graphical Unit Interface available, while there is an active failure, a press on failure pictogram shall display the pop-up specify on ELV-3142 "2.a."8.6.3 Interface with Service Tool 8.6.3-1 - The Service Menu shall provide a user access to read:1) The MAC and the physical IP address of Wifi Module of the product.Prepared by Merrill, David REVISION 182928 Date 2026-06-19 00:49REVISION 182928 Date 2026-06-19 00:49 Prepared by Merrill, DavidPrepared by Merrill, David Date 2026-06-19 00:49 REVISION 182928REVISION 182928 Prepared by Merrill, David Date 2026-06-19 00:49Date 2026-06-19 00:49 REVISION 182928 Prepared by Merrill, DavidPrepared by Merrill, David Date 2026-06-19 00:49 REVISION 182928REVISION 182928 Prepared by Merrill, David Date 2026-06-19 00:49Prepared by Merrill, David Date 2026-06-19 00:49 REVISION 182928Prepared by Merrill, David REVISION 182928 Date 2026-06-19 00:49Prepared by Merrill, David Date 2026-06-19 00:49 REVISION 182928Prepared by Merrill, David Date 2026-06-19 00:49 REVISION 182928REVISION 182928 Date 2026-06-19 00:49 Prepared by Merrill, DavidDate 2026-06-19 00:49 Prepared by Merrill, David REVISION 182928Date 2026-06-19 00:49 Prepared by Merrill, David REVISION 182928Date 2026-06-19 00:49 Prepared by Merrill, David REVISION 182928Date 2026-06-19 00:49 REVISION 182928 Prepared by Merrill, DavidDate 2026-06-19 00:49 Prepared by Merrill, David REVISION 182928Date 2026-06-19 00:49 REVISION 182928 Prepared by Merrill, Davidoplesiye: ‘Max Load 200 kg Load at the CSP Usage CSP athigh position | CSP starting from 76° ZARWUP) going trom"atob-& perform Typical it NPOTIG4S Eee cycle ‘Empty 1 3811 NA "50k9 969% NA 3658 ‘200 kg + NA 152 TOTAL 100% 3811 381 Cer ‘Empty i 3811 NA ES 150 kg 9596 NA 3620 200 kg + NA 152 250 kg 1% NA 8 TOTAL 100% 3811 Bett Max Load 300 kg empty in 3811 NA "0K9 359% NA use [Pook 12% NA 457 |250ka + NA 152 300 kg 2m NA 37 TOTAL 100% set Bett TOTAL 100% 3811 Bett Ceres empty in 3811 NA "0K9 6596 NA 2677 [Pook 20% NA 762 |250ka 10% NA 381 |300 kg 2 NA 76 Se3 kg a NA 76 454 kg. 1% NA 38 I TOTAL 100% 3att 3att CEILING Ceiling or rail devices {Side View) FLOOR t1CSP at the upper position Typical Usage Cycle +2 Lower the sling bar to hook the sling loop _ 13 Install the patient on the sling (CSP position) 4 First raise up of the patient 3000 +5 Adjust height before transferring patient 6 Max height to do the transfer 7 Transfer the patient e 8 Lower the patient +9 Adjust height before completely lowering the patient - 10 Completely lower the patient t11 Unhook the sling bar 2500 5565 12 Raise up the sling bar to park the lift a a in 55 seconds at 60 mm/sec 2000 1500 + 1000 =e=Step & floor i: =©=CSP position 200 == Upper limit from ceiling 0 $< —$<$— i tL 12 3 4 tS 16 yg 18 9 110 tii 112 CEILING Rail Hoist (Side View) + Emergency Stop + Emergency Lowering Max Load 200 kg Lift cyles/year Load at the CSP Usage CSP at high position CSP starting from “b" %(RWUP) going from “ato b” & _ perform Typical lift cycle NPD11646, “btoa” Empty i 80 NA 150 kg 88% NA 70 [200 kg 12% NA 10 TOTAL 100% 80 80 (eee Empty i 80 NA 150 kg 76% NA 61 200 kg 12% NA 10 250 kg 12% NA 10 TOTAL 100% 80 80 eee Empty i 80 NA 150 kg 64% NA 52 200 kg 12% NA 10 250 kg 12% NA 10 300 kg 12% NA 10 TOTAL 100% 80 80 mpty 7 80 NA 150kg 48% NA 35 [200 kg 20% NA 16 250 kg 12% NA 10 300 kg 12% NA 40 363 kg 12% NA 10 TOTAL 100% 80 80 Empty i 20 NA 150kg 32% NA 26 200 kg 20% NA 16 250 kg 12% NA 40 300 kg 2% NA 10 363 kg 12% NA 10 454 kg 12% NA 30 TOTAL 100% 80 802500 2000 1500 1000 500 -500 Full lenght strap usage cycle (CSP Position) t1CSP at the upper position 2 Lower the sling bar to hook the sling loop 13 Install the patient on the sling 14 First raise up of the patient 5 Adjust height before transferring patient t6 Max height to do the transfer 7 Transfer the patient 8 Lower the patient +9 Adjust height before completely lowering the patient 10 Completely lower the patient 11 Unhook the sling bar 12 Raise up the sling bar to park the lift in 108 seconds at 60 mm/sec 1310 —O=Step & floor =©= Upper limit from ceiling —©=CSP position 112Display Start message before calibration y Weight Y= MAK i ‘y=beam_constant * x+beam_offset step y= Weight (Kg= x= Value beam (81 + 82) vaeMax 2 a ‘beam_constant = (YA -¥3)/(X1-X3) Step2 Set coefficient gain and offset at ave . |s the inertial unit calibrated, previous value ‘beam_offset = V1 -(beam_constant *X1) vas00Kg nan eae Step 3 with correct angle (TBD) ? Value beam - Disable “Start” button x2 x {on the display) Step2 step 1. = Calibration not possible. Inform end calibration status Enable "Start" button {on the display) Edit Local Altitude and Latitude with the screen Next button and Start calibration © SEo 0 Go 8 60 41 30 00 00 00 00 00 189 Q Qo 8 00 00 00 00 O04 20 70 OO 189 0 0 8 00 00 00 oo[op oo 70 20 [step 4 with Max weight ‘Sept Set Max kg and press next| vom usr wih messepe Step 1 No Next button press 2 i 679 o o 8 23 41 30 00 03 00 00 00 SES 0 0 8 60 41 30 00 00 00 00 00 Yes Stabilization No of RawBeamData[LEFT_BEAM] + RawBeamData[RIGHT_BEAM] with a . ete) Gane Read PDO 189 Oxo: 189 0 0 8 00 60 00 00 o4 30 so oo Head p60; 160 189 0 0 8 00 00 00 00 04 40 70 00 [Save the value X1 (sensor response) Value is a mean during Xs linked fo Beam max ‘Step 2 with 100 kg weight |Inform user with message Start Step | ‘Step2 : Set 100 kg and press next. 2 No _ 679 0 0 8 23 41 30 00 00 00 — SE9 0 6 8 60 41 30 00 00 00 00 00 Next button press ? Yes od PDO 189 0x05 w 189 0 0 8 00 00 00 00 04 So So 00 See. Inform user itn message Sten 2 No Stabilization ‘Wat <taiteaion ana ‘of RawBeamData[LEFT_BEAM] + say RawBeamData[RIGHT_BEAM] with SERS MEER: value TBO during TBD min Read PDO 169 0x06 A 189 0 0 8 00 00 00 00 04 60 70 00 Value isa mean during Xs No . - 673 0 0 8 23 41 30 00 03 00 00 00 ext bution press 9 Me SFO 0 0 8 60 41 30 00 00 00 00 00 ie Read PDO 189 0x07 Add: 189 0 0 8 00 00 00 00 04 70 70 00 Inform user with message Step 2 Stabilization of RawBeamData[LEFT_BEAM] + RawBeamData[RIGHT_BEAM] with value TBD during TBD min Value is a mean during Xs ‘Compute Coefficient (gain and Joftset) with Beam max and beam 0 beam_constant & beam_ofiset Compute % failure with 100 kg ASompare Y2Compute and ‘Y2Theoric (120 Ka). Failure ? |Save coefficient calibration (gain and| Inform Calibration failure on the offset) on EEPROM. screen Recompute Gravity Factor (© 1 after calipration) Display end calibration success on the screen Display Start message before calibration y Weight Y= MAK i ‘y=beam_constant * x+beam_offset step y= Weight (Kg= x= Value beam (81 + 82) vaeMax 2 a ‘beam_constant = (YA -¥3)/(X1-X3) Step2 Set coefficient gain and offset at ave . |s the inertial unit calibrated, previous value ‘beam_offset = V1 -(beam_constant *X1) vas00Kg nan eae Step 3 with correct angle (TBD) ? Value beam - Disable “Start” button x2 x {on the display) Step2 step 1. = Calibration not possible. Inform end calibration status Enable "Start" button {on the display) Edit Local Altitude and Latitude with the screen Next button and Start calibration © SEo 0 Go 8 60 41 30 00 00 00 00 00 189 Q Qo 8 00 00 00 00 O04 20 70 OO 189 0 0 8 00 00 00 oo[op oo 70 20 [step 4 with Max weight ‘Sept Set Max kg and press next| vom usr wih messepe Step 1 No Next button press 2 i 679 o o 8 23 41 30 00 03 00 00 00 SES 0 0 8 60 41 30 00 00 00 00 00 Yes Stabilization No of RawBeamData[LEFT_BEAM] + RawBeamData[RIGHT_BEAM] with a . ete) Gane Read PDO 189 Oxo: 189 0 0 8 00 60 00 00 o4 30 so oo Head p60; 160 189 0 0 8 00 00 00 00 04 40 70 00 [Save the value X1 (sensor response) Value is a mean during Xs linked fo Beam max ‘Step 2 with 100 kg weight |Inform user with message Start Step | ‘Step2 : Set 100 kg and press next. 2 No _ 679 0 0 8 23 41 30 00 00 00 — SE9 0 6 8 60 41 30 00 00 00 00 00 Next button press ? Yes od PDO 189 0x05 w 189 0 0 8 00 00 00 00 04 So So 00 See. Inform user itn message Sten 2 No Stabilization ‘Wat <taiteaion ana ‘of RawBeamData[LEFT_BEAM] + say RawBeamData[RIGHT_BEAM] with SERS MEER: value TBO during TBD min Read PDO 169 0x06 A 189 0 0 8 00 00 00 00 04 60 70 00 Value isa mean during Xs No . - 673 0 0 8 23 41 30 00 03 00 00 00 ext bution press 9 Me SFO 0 0 8 60 41 30 00 00 00 00 00 ie Read PDO 189 0x07 Add: 189 0 0 8 00 00 00 00 04 70 70 00 Inform user with message Step 2 Stabilization of RawBeamData[LEFT_BEAM] + RawBeamData[RIGHT_BEAM] with value TBD during TBD min Value is a mean during Xs ‘Compute Coefficient (gain and Joftset) with Beam max and beam 0 beam_constant & beam_ofiset Compute % failure with 100 kg ASompare Y2Compute and ‘Y2Theoric (120 Ka). Failure ? |Save coefficient calibration (gain and| Inform Calibration failure on the offset) on EEPROM. screen Recompute Gravity Factor (© 1 after calipration) Display end calibration success on the screen 4.6.2 Echelon L'échelon d'un dispositif de pesage de la tare doit étre égal a l'echelon de I'instrument pour toute valeur donnée de la charge.4.5.1 Effet maximal L'effet d'un dispositif de mise a zéro quelconque ne doit pas modifier la portée maximale de l'instrument. L'effet total des dispositifs de mise a zéro et du dispositif de maintien du zéro ne doit pas dépasser 4 % de la portée maximale, l'effet du dispositif de mise a zéro initiale ne devant pas dépasser 20 %. Cette disposition ne concerne pas les instruments de classe Illl, sauf s'ils sont utilisés pour des transactions commerciales. Une étendue plus large est autorisée pour le dispositif de mise a Zéro initiale si l'instrument satisfait a 3.5, 3.6, 3.8 et 3.9 pour toute charge compensée par ce dispositif dans |'étendue spécifiée. 4.5.1 Effet maximal L'effet d'un dispositif de mise a zéro quelconque ne doit pas modifier la portée maximale de I'instrument. L'effet total des dispositifs de mise a zéro et du dispositif de maintien du zéro ne doit pas dépasser 4 % de la portée maximale, l'effet du dispositif de mise a zéro initiale ne devant pas dépasser 20 %. Cette disposition ne concerne pas les instruments de classe Illl, sauf s'ils sont utilisés pour des transactions commerciales. Une étendue plus large est autorisée pour le dispositif de mise a Zéro initiale si l'instrument satisfait a 3.5, 3.6, 3.8 et 3.9 pour toute charge compensée par ce dispositif dans |'étendue spécifiée. 4.5.1 Effet maximal L'effet d'un dispositif de mise a zéro quelconque ne doit pas modifier la portée maximale de I'instrument. L'effet total des dispositifs de mise a zéro et du dispositif de maintien du zéro ne doit pas dépasser 4 % de la portée maximale, l'effet du dispositif de mise a zéro initiale ne devant pas dépasser 20 %. Cette disposition ne concerne pas les instruments de classe Illl, sauf s'ils sont utilisés pour des transactions commerciales. Une étendue plus large est autorisée pour le dispositif de mise a Zéro initiale si l'instrument satisfait a 3.5, 3.6, 3.8 et 3.9 pour toute charge compensée par ce dispositif dans |'étendue spécifiée.4.6.6 Dispositifs soustractifs de tare Lorsque l'utilisation d'un dispositif soustractif de tare ne permet pas de connaitre la valeur du reliquat de l'étendue de pesage, un dispositif doit interdire l'emploi de I'instrument au-dela de sa portée maximale ou signaler que cette portée est atteinte.4.6.4 Plage de fonctionnement Le dispositif de tare doit étre tel qu'il ne puisse pas étre utilisé a ou en deca de son effet zéro, ou au-dela de son effet maximal indiqué.3.5.3.4 Dispositif de pesage de la tare Les erreurs maximales tolérées sur un dispositif de pesage de la tare sont, pour toute valeur de tare, les mémes que celles tolérées sur l'instrument pour la méme valeur de charge.Battery ederc es Load at the CSP _Usage % Number of cycle 150 kg 65% 80 200 kg 4% 71 | oad 250 ke 150 kg 60% 80 250 kg 3% 63 | ES 150 kg 50% 80 300 kg 3% 55 150 kg 40% 80 363 kg 3% 45 150 kg 30% 80 454 kg 1% 30