C evaluation 362 MEDICAL DEVICES AGENCY evaluation ‘SUMMARY ‘Avaliable in a number of configurations with: '* vertical height adjustment or fixed height stand © optional servo-controiled oxygen ‘© passive humidity contro! (optional servo-controlied) ‘Adeartagee: 0asy 10 u28; good deplays and controls fand lam funetons; good temperature stably and ‘option: variable height adjustment; RS232 port; good/excollent manuals; controller units easily interchanged; well constructed. Disadvantages: several parts to dismantle for ‘leaning: our evaluation unit had an offset in the air Jemperatue indicator, ‘Overall: An easy incubator to use with good controls, NUMBER, 362 NURSING INCUBATORS Ohmeda Care Plus 4000 MAIN FEATURES BRIEF DESCRIPTION The Ohmeda Care Plus 4000 nursing incubator comprises a baby compartment enclosed by a transparent double-walled canopy with hand and tubing ports and a large front door. The baby compartment height can be adjusted electrically. The incubator Provides: airtemperature and baby-temperature Control; supplemental relative humidity; and features a Variable Uit baby tray with mattress; digital temperature displays; a battery pack and charger for alarm circultry, and an air iter Optional accessories include: baby ecales; shelves and storage areas; disposable hand-port cuts; servo- controlled humidification ‘servo-controlled ‘oxygen control system: oxygervair blender, oxygen flow= meter; infusion stand and a sterilizer tank for the control unit © crown copyright, Double walled canopy Yes ‘Access and handling * hand ports 5 * access door Yes, front = tubing ports 6 + tray withdrawal Yes, front * tray titing mechanism Yes, + 12 degrees * baby compartment Yes, optional vertical height adjustment Controller + airtemperature 20°C to 39°C + baby-temperature 95°C to 37°C. Alarms ‘+ mains power failure yes high air temperature yes + skin temperature yes Price ex VAT. ‘Made in In range £6,880 to USA £10,980 dependent on ations chosen Weight ‘Supplier e4kg ‘Ohmeda ‘Ohmeda House Size HxWxD 71 Great North Road 196 x 89 x 65 cm Hatfield Herts ‘DH registered manufacturer? Yes, RO451/M CE Marking on product? —_Yes, (MO directive) How is safety demonstrated? Independent certifcation to: IEC 601-1-2:1983 (EMC) IEC 601-1:1989 IEC 601-2-18:1990 ‘Nolo: Manufacturers may be registered, de-ogistered 0: re registred at any timo. Consul te latst issue ofthe MDA FRgistor of Manufacturors to check curent status.Ohmeda Care Plus 4000 DESCRIPTION The Ohmeda Care Plus 4000 is a microprocessor-controlled nursing incubator that is composed of a baby compartment and lower unit mounted on a central column. The baby ‘compartment is enclosed by a rectangular, double- walled, transparent acrylic canopy with access and tubing ports and a large door. Beneath the baby compartment an enclosed ‘section contains the plug-in contro! unit with heater ‘element and fan. The lower unit also contains the controls for the continuously variable mattress tit mechanism and, at the rear, the disposable air-fiter ‘and, at the side, an oxygen-inlet. ‘The central column houses the electrically ‘operated height adjustment mechanism. Two (optional) storage units can be mounted, one either side of the central column; and an (optional) rail system is avaliable which allows (optional) swivel shelves and accessories to be fitted at each end of the incubator. The incubator is mounted on four castors; the front two have foot-actuated locks. The incubator is capable of either air- temperature or baby-temperature controlled operation, There is a system of alarms and temperature protection devices. USER FACILITIES ‘Access: There is a large access door in the front panel which can be hinged down. It has @ counter balance to help to prevent the door faling open if the latches are not locked. There are five access ports with spring loaded doors; two in the access door, two in the rear panel and one in the right-hand ‘end panel (Photo B). There is a large tubing port in the left-hand end panel which is sealed with a disposable cuff that can be opened and closed with an ‘ris’ action. There are two other tubing ports in the front bottom comer of each end panel and there {s a small tubing hole in the roof of the canopy. Any ‘access port can be converted into @ large tubing port and vice versa (with the appropriate spare part). Baby tray: The mattress rests in a tray whose sides extend above the mattress on three sides. When horizontal it can be partially withdrawn straight out of the opened front access door. A continuously verlable tit mechanism, operated via two rotary controls on the front comers of the lower Unit, allows the mattress tray to be set in either @ head up or feet up position, up to a maximum of 12 degrees (Photo C). Xcray facilities: There is no X-ray cassette drawer ‘or shelf. The supplier says that if the mattress tray is raised the X-ray cassette can be placed below it, in the moulded recess provided, to prevent disturbance to the baby. ‘evaluation no 962, May 1998Ohmeda Care Plus 4000 Vertical height adjustment: The electrically ‘operated vertical height adjustment (VHA) mechanism allows the height above the floor of the baby compartment and the fower unit to be varied. ‘The maximum height of the mattress above the floor is 107 cm.(Photo D}; the minimum is 85 cm (Photo E). The height is continuously adjustable between these values and the VHA is operated by a footswitch at the base of the central colunn. Cleaning: To facilitate cleaning the incubator can be dismantied. The canopy is hinged at the rear @ 2602 271 can be opened up to alow greater access to the baby compartment (Photo F). The inner wall of the canopy can be removed. The entire contro! unit, including the heater element and fan can be withdrawn (Photo G) and cleaned by partial immersion in a sterilizing unit; available as an accessory. The ait iter Is disposable. Accessories: A range of accessories is available. ‘These include an oxygen flowmeter, an oxygen/air blender, @ phototherapy lamp, a cabinet module, & rail system for mounting shelves and accessories, an IV pole, a remote alamvRS232 module, a weighing scale and a steriizing unit for the control unit. Configuration: The microprocessor controlier hokés default values for control settings that are initiated when the incubator is tumed on. At start-up the unit defaults to air-temperature control mode at a control temperature af 33°C, the enable ‘switch is activated, the heater is off, and an intermittent auditory alarm is activated. The user must set the control temperature to enable the unit. ‘The microprocessor continuously performs a series of testa during normal operation and if one of these tests fails an ever code will be displayed in place of the control temperature. Additional service data Is also available via the front panel to assist maintenance and repair. Environmental control: The indicators and all user controls (except the humidity and oxygen controls) are positioned on the front of the control unit and all controls are tactile membrane switches (Photo H). The operation of @ control must be preceded by the actuation of a keypad enable ‘switch which enables the control panel for a fixed length of time, The selection of the desired mode of ‘operation is by the appropriate switch and the mode cof operation is shown by an illuminated indicator. Heater operation is indicated by the proportional ilumination of a vertical four-segment bar lamp. evaluation no 362, May 1998Ohmeda Care Plus 4000 ‘evaluation no 362, May 1998 4Ohmeda Care Plus Air-temperature control: The ait-temperature ‘control range is from 20°C to 37°C in steps of 0.1°C. ‘After the operation of an over-ride switch the air temperature may be set up to a maximum of 39°C. This is indicated by a flashing indicator on the “Air (Override >37°C" switch. When operated in the air- temperature controlled mode, the air temperature is monitored by the primary sensor located on the rear wall of the canopy. Information from this sensor is used by the electronic heater control circuits to proportionately control the heater output. Baby-temperature control: The baby-temperature control range is from 35°C to 37°C in steps of 0.1°C. ‘An intemal adjustment changes the upper limit to 87.5°C. The incubator is operated in the baby- temperature controlled mode by monitoring the baby's skin temperature using the skin temperature sensor provided. Information from the skin temperature sensor is used by the electronic heater control circuits to proportionately control the heater output. Disposable skin temperature sensors and adhesive probe covers are available as acessories. eee os Temperature displays: The control temperature, the air temperature and, when the skin temperature sensor Is in use, the skin temperature, are continuously shown by separate digital displays (Photo H). There is no liquid-in-glass thermometer but the air temperature is monitored by an electronic sensor that is independent of the air temperature control mechanisms. Humidity control: The standard humidity option allows two humidity settings Low (45%) and High (65%) to be chosen. The relative humidity achieved will depend upon ambient conditions. ‘The unit we evaluated included the optional Ohio® Care Plus® servo-controlled humi Relative humidity can be set to between 40% and 85% in 5% steps using tactile switches on the controller mounted at the front of the humidifier (Photo 1). The humidity is measured by a sensor mounted on the rear canopy wall. A digital display indicates the measured humidity. There is an auditory and visual waning of a low water level, for ‘sensor malfunction and for intemal malfunctions. Both humidifier options are filled by withdrawing the reservoir from the front of the incubator. ‘evaluation no 362, May 1998Ohmeda Care Plus 4000 ‘The incubator must be operated with an empty reservoir in place when no supplemental humidity is required. ‘Oxygen controt: Supplemental oxygen can be introduced to the circulating sir by way of an inlet port (Photo J). An oxygen pressure limiting device and flow meter are not fitted as standard but are available as accessories. There is an optional oxygen controler the ‘ServO,™ which can be used to servo-control the ‘oxygen volume concentration within the baby ‘compartment or @ head box. The control range is from 21% to 90% in 1% steps. Air circulation: Fresh air is drawn into the incubator through a large disposable air filter mounted in the rear of the lower unit. Fitered air, with recirculated air and any supplemental oxygen, is driven by the fan over the heater. All the heated air mixes and enters the baby compartment along the front edge of the canopy. The heated air is directed upwards into the gap between the double walls, and passes through this gap above the mattress and is drawn down along the rear edge of the canopy to be recirculated. When the main access door is opened the heated al flows upwards from the front edge of the canopy past the access door opening creating a warm air curtain. ‘The incubator has an automatic alarm and systems check sequence after switch-on. Alarm indications are provided for mains power failure, electronic system failure, inadequate air circulation, probe failure, high air temperature and for the variation of the air or skin temperature from the control temperature set by the user (control temperature alarm). visual waming of an alarm condition is given by Muminating a red indicator on the control panel. ‘There is also an auditory waming of each alarm ‘evaluation no 362, May 1998Ohmeda Care Plus 4000 condition. With the exception of power failure and system failure, all of the auditory alarms can be silenced by the user for a time which depends upon the specific alarm condition. The auditory alarms that can be silenced are visually displayed by twin flashing red indicators on the alarm silence switch. ‘Two afferent auditory alarm modes indicate the priority of the alarm. An altemating two tone alarm indicates a critical alarm condition and automatic heater shutdown. Lower priority alarms are Indicated by an intermittent single tone whose ‘on-period increases after a fixed time if no action is taken by the user. The control temperature alarm is automatically silenced during warming up and for a time after subsequent changes in control temperature and is selt-resetting. With the exception of the high temperature alarm all other alarms are selt- resetting. The high temperature alarm must be reset by depressing the alarm silence button even when the alarm condition has been corrected. Serial Ports Anine pin D terminal output socket is provided at the side of the control pane! for the (optional) ‘ThermaLink interface. This interface includes an F3S232 serial link for remote gathering of data from the incubator. In addition, separate contacts in the ‘output socket provide a Nurse Call remote alarm facility for connection to a remote monitor. USER EVALUATION ‘The Ohmeda Care Plus 4000 was used in a ‘neonatal intensive care unit for several weeks, after which the users were asked to score the facilities and attributes of the incubator on a five point scale. ‘These were aggregated and are depicted in Figure 1 as a bar chart to show initial user assessment of the incubator. The user evaluation indicates the assessment of the Ohmeda Care Plus 4000 at the time of testing and should not be used as a comparison with earlier evaluations but as a ‘measure of the Ohmeda Care Plus against current ‘customer expectations. ‘All our users received the standard Ohmeda training and demonstration (rated by our users as 900d). Following this most staff found the incubator easy to use. Selection of the mode of operation ‘was easy and the control layout and the displays, ‘were good. The alarms were both clear and visible. ‘The incubator was very quiet in operation. ‘Access for nursing and medical procedures and ‘general care was good. The mattress tray could be withdrawn through the front door for medical procedures, like intubation. A number of our users found the tray “bumpy” to withdraw. All our users felt there was adequate space within the baby ‘compartment for nursing procedures. The mattress tit mechanism was good, allowing an easily adjusted tit adjustment to any angle up to the maximum. Access ports for tubing and monitor leads were found to be satisfactory/good. The servo-controlled humidity system was easy to use. The variable height adjustment of the incubator was a particularly good feature and was appreciated by all staff and parents alike; especially mothers in wheelchairs. All storage space is optional. The unit we evaluated was fitted with 3 drawers and twin monitor shelves on a rail system. Most users felt that this storage space was satistactory/good. A number of users thought that the combination of drawers and shelves was particularly useful and variable and able to take a variety of equipment. evaluation no 362, May 1998Ohmeda Care Plus 4000 Most staff found the unit easy to disassemble and reassemble during cleaning, but some criticised the number of parts and felt that there were too many dirt traps, which extended the time required to clean the unit. Our users would have preferred all surfaces to be very smooth for easy cleaning. Overall the incubator was given a good performance rating. TECHNICAL EVALUATION A sample of the Ohmeda Care Plus incubator was submitted to BSI Testing, Hemel Hempstead by ‘Ohmeda Inc. and was found to comply fully with IEC 601-2-19 (1990) and EN 60601-1-2 (see Appendix 2) and was given a certificates of test dated 16th February 1996 and 11th December 1995. In addition, by affixing CE marking to the product in respect of the Medical Devices Directive, the manufacturer has indicated that it complies with the UK regulations implementing the Medical Devices Directive. In support of this the supplier has submitted a copy of the Quality Assurance Certificate (Certificate Number 1236, April 1996) issued to the manufacturer, Ohmeda Inc., Specialty products Division by BSI (notified body 0086) to confirm compliance with Council Directive 99/42/EEC, Annex I, Article 3 by demonstrating compliance with the Full Quality Assurance System. We performed tests on a sample in Cardiff to a sub-set of IEC 601-2-19. The results of our technical evaluation of the Ohmeda Care Plus incubator are summarised in the Results Table on page 16. Safety and performance: On the evaluation sample tested in Cardiff we found no safety shortcomings. However, the alr temperature indicator only just met the requirements of the Standard (see Manufacturer's Comments). Our detailed findings are as follows. Incubator stability and security: The incubator was mobile and stable in normal use and the wheel locks were effective. The canopy could be securely locked open for cleaning. The latches on the hand ports were good: there was no possibilty that the doors could be insecurely closed or pushed open from within, The main access door was adequately secured. The mattress tray was stable and well ‘supported when withdrawn through the front access door. Air temperature indication: The indicated air temperature was always lower than the actual incubator air temperature at the centre of the mattress. The difference between the indicated and actual air temperatures was affected by the ambient air temperature. For example at an ait control ‘temperature of 96°C and an ambient teriperature of 25°C the actual air temperature at the contre of the mattress was 36.4°C. At an ambient temperature of 21°C the actual temperature at the centre of the mattress was 96.7°C. ‘At control settings up to 36°C the indicated air temperature and actual incubator air temperature was within the 0.8°C maximum difference specified in the Standard. Compliance with this 0.8°C limit at higher air control temperatures is not required by the Standard, The actual temperature at the centre of the mattress exceeded this limit for air control temperatures above 36°C. For example, at a contol setting of 39°C the actual temperature at the centre of the mattress was 40°C. ‘Air temperature control: The incubator maintained a stable environment within the baby ‘compartment for any set temperature and any mattress orientation. However, as noted above, the air temperature indicator only just met the evaluation no 362, May 1998Ohmeda Care Plus 4000 equirements of the Standard (see Manufacturer's Comments). ‘The variation in temperature across the mattress was low (only 0.5°C) for any mattress orientation - a very good result, ‘We tested the effects on air temperature control of ‘pening the incubator ports and doors (Figure 2). At ‘an air control temperature of 36°C the maximum fall in incubator air temperature after opening four hand port doors for five minutes was 1.6°C and steady state was regained within two minutes of closing the port doors. Opening the front access door fully for 5 minutes resulted in a maximum fall in incubator air temperature of 3°C and steady temperature condition was regained within 12 minutes of closing the door. ‘Warm-up time: The incubator warmed up from cold (22°C) to 11°C above ambient temperature (83°C) in 16 minutes with the servo-controlled humidifier set to 85% RH. The response of the incubator to a change in control temperature was good; steady state was, achieved within 13 minutes of the change. Skin temperature indication and control: The skin temperature accurately ‘temperature when immersed in a water bath. With the sensor suspended within the baby compartment and used in the baby-temperature controlled mode to control the air temperature, a stable temperature was maintained close to the control temperature. sensor indicated the incubator air temperature or the skin temperature deviated by more than a factory set ‘amount from the control temperature set by the user and it operated as specified by the manufacturer. Fan fail alarm: The failure of the air circulation was detected by an optical sensor located near the heater. Jamming the fan or stalling the motor caused an auditory alarm, visual alarm and deactivation of the heater within 25 seconds - a very good result. ‘Temperature sensor failure alarm: The incubator monitored all sensors electronically for fault ‘conditions. Sensor failure was detected quickly resulting in an auditory alarm, visual alarm and deactivation of the heater. Power fail alarm: The power failure alarm reacted immediately to removal of the supply mains. The mode of operation and control settings were unaffected on restoration of the power supply. Incubator noise and alarm sound pressure levels: Noise levels within the baby compartment, bboth with and without the alarms operating, were below the upper limits set by the standard for normal operation. The main auditory alarm sound pressure level externally exceeded the minimum (65 dB A- weighted) required by the standard. Humidity Control: When using the Ohio® Care Plus® servo-controlied humidifier system relative humidities greater than 80% were achieved at an incubator air temperature of 39°C (room temperature 20.2°C, room RH 52%) although at this, level of humidity there was considerable rain-out on the inside of the canopy. The measured relative humidity inside the baby compartment for various control settings is shown in Figure 3. The displayed relative humidity was close to the measured value at all humidity settings - a good result ‘We tested how opening four hand port doors and front access door effected humidity control (Figure 4). The incubator was operated in the air- temperature controlled mode at a control temperature of 39°C with the humidifier at 85% ‘output setting and the incubator relative humidity (IRH) was 82%. ‘The room temperature was 21°C. and relative humility 51%, evaluation no 362, May 1998Ohmeda Care Plus 4000 ‘After opening four hand port doors for 5 minutes the IRH had fallen to 62%. However, it was over ‘80% within 3 minutes of closing the port doors, Five minutes after opening the front access door the IRH had fallen to 35% but it was over 80% within 5 minutes of closing the front access door. Reliability: There were no faults on delivery and one in use. The incubator was robust and ‘constructed to a high standard. It should therefore be reliable. Serviceability and manuals: The user manual was very good and the service manual was excellent, They were clear with many explanatory drawings. ‘The user manual contained a good description of the functioning of the incubator. Detalled operating and cleaning information was given. There was @ separate manual for the vertical height adjustment option and one for the servo-controlled humidification system. The service manual gave a full technical description and it contained good circuit diagrams. Fault finding procedures and set-up and calibration routines were given. The microcontroller displayed error messages caused by intemal malfunctions ‘The service manual included detailed explanations for the messages and suggested po: corrective actions. There was a full parts list and constructional diagrams. le The electronic controller was self-contained and could be easily removed for servicing or calibration. ‘The printed circuit boards were easily accessed. COMPLIANCE WITH STANDARDS By affixing CE Marking to the product in respect of EC Medical Devices Directive, the manufacturer has indicated that it complies with the UK regulations implementing the Medical Devices Directive (99/42/EEC), In support of this the supplier submitted 2 copy of Quality Assurance Certificate (Certificate Number 1236, March 1996) issued to the manufacturer, Ohmeda Inc. by BSI (notified body 0086) to confirm compliance with Council Directive 93/42/EEC, Annex Il, Section 32 by demonstrating compliance with {SO ‘9001/EN46001. In addition, a sample of the Ohmeda Care Plus Incubator submitted by Ohmeda to BS! testing independently of the evaluation, has been granted a Certificate of Compliance (No. §ME000783 February 1996) with IEC 601-1:1988 and IEC 601-2-19:1990 and a Certificate of Compliance (No. EZ000334 December 1995) with IEC 601-1-2:1993, MANUFACTURER'S COMMENTS. The findings of the report were sent to the Manufacturer and Supplier who resoponded as follows: “We thank Dr. Hacking and the Medical Devices Agency for providing an excellent review of the Care Plus incubator and also for allowing this, opportunity to provide our comments. ‘Ohmeda's Care Plus incubators provide superior thermal stability for the premature neonate. This superior thermal performance results from a number of features unique to the Care Plus incubator. (MDA note: Manufacturer's claims.) ‘These features combine to create a stable thermal environment during steady-state conditions or nursing intervention. The Care Plus incubator air temperature probe is located on the rear wall of the incubator, directly above the centre of bed. At this location, the air temperature sensor is closer to the patient position ‘evaluation no 362, May 1998 10Ohmeda Care Plus 4000 than other incubators. detected by this probe will be that most directly surrounding the patient, providing the care giver a precise reading of the patients environment. The air temperature (MDA note: Our results indicate that the air temperature was always higher than the Indicated reading - see Technical Evaluation.) The Care Plus incubator may also be equipped with inner walls on the front, rear and top of the incubator hood. The top inner wall provides the most benefit in reducing an infants radiant heat loss. The greatest surface area exposure by the infant is through the top of the incubator hood. All Care Plus incubators have been designed to ‘accommodate a top inner wall for this reason. ‘The air circulation pattern of the Care Plus incubator directs heated air between the outer and ner walls of the incubator, completely surrounding the patient with a warmed hood. The effect provides a reduction in radiated heat losses not achieved by conventional single walled incubators or double walled incubators that do not provide active air flow between the walls. Heater output is controlled proportionally in air control mode. However, in the baby control mode, the Care Plus incubator utilizes a proprietary ‘cascade control algorithm. Cascade control adjusts the incubator temperature based on the patients response to previous control settings. Each adjustment occurs periodically, simulating the adjustments made by a clinician. Thus cascade ‘control minimizes patient temperature fluctuations. (MDA note: Manufacturer's claim.) Despite the many technical features, the Care Plus incubator has been designed to simplify the care givers efforts. Optional accessories and mounting devices position equipment within arms reach. The continuous tit mechanism allows precise adjustment in Trendelenburg or reverse Trendelenburg positioning of the infant and accommodates X-ray cassettes beneath the mattress. Every component has been designed for easy hand disassembly to provide cleaning access ‘as required by each particular facility.” (MDA note: See User comments on cleaning.) Evaluation for "1 evaluation no 362, May 1998Ohmeda Care Plus 4000 ‘Supplier DH registered manufacturer?’ Country of origin Certificated product Price Dimensions overall (H x W x D) baby tray (W x D) weight Vertical helght adjustment Double walled canopy Access and handling hhand ports, access door tubing ports tray tilt mechanism tray withdrawal X-ray cassette drawer ‘Temperature control? air-temperature baby-temperature MANUFACTURERS INFORMATION Yes, RO451/ME usA Yos,EC 601-1 IEC 601-2-19 IEC 601-1-2 (EMC) £6,880 with fixed height stand, non-servo humidity control to £10,980 with 1. Servo-controlled humigity 2. Variable height stand 3. Thermalink S232 option 4, Ralls & storage modules 135.9 x 88.9 x 64.8 cm 65 x 34.8.cm 84,04 kg (with standard cabinet) ‘Yes, mattress height 85 cm minimum, 107 cm maximum above floor Yes 5 Yes, front 6 Yes, up to #12 degrees continuously variable Yes, front No 20°C to 37°C (0.1°C) (up to 39°C with front panel Override switoh) 35°C to 37°C (0.1°C) (up to 37.5°C with intemal adjustment) ‘evaluation no 362, May 1998 12Ohmeda Care Plus 4000 MANUFACTURERS INFORMATION (Cont'd) Maximum canopy air temperature air-controlled mode baby-controlled mode ‘Temperature displays * air temperature ‘skin temperature canopy thermometer heater power indication Alarms mains power failure fan failure probe failure skin sensor detached high air temperature skin temperature control temperature electrical fault Air humidification filter Oxygen provision inlet por. flow meter servo-control Data output NOTES 41. Manufacturers may be registered, de-registered or re-registered at any time. Consult the lastest issue of the DH Register to check current status. 2. Value in brackets is control resolution. 40°C 38°C digital (0.1°C) digital (0.1°C) no. 4 segment lamp yes yes yes no yes yes yes yes optional Ohio® Care Plus* servo-controlled humidifier, RH 40-85% (5%). Integral RH ‘monitor. 1, disposable yes, up to 75% optional Serv0," option, 21-90% (1%). Integral ‘oxygen monitor. Yes, optional RS232 Thermalink 13 evaluation no 362, January 1998Ohmeda Care Plus 4000 ‘maximum response time quoted (normal hours) temporary equipment replacement? Servicing Total Support Contract All emergency (in normal hours) and four planned visits per year. Includes labour and travelling and all parts (excluding disposables and accessories) PRODUCT SUPPORT ‘Supplier ‘Ohmeda ‘Ohmeda House 71 Great North Road Hatfield Herts Tel. 01707 263570 Fax. 01701 260065 Guarantee 1 year Maintenance provisions service contract? Yes will service engineer call? Yes 6 hours, Total Support Contract 4 days, Basic Support Contract (Note: out of hours emergency call-out available) ‘The Ohmeda Care Plus can be serviced by the user after attending a training course runby the supplier (£600 - £1,000). The supplier also offers the following service agreements: £395.32 per annum Out of hours emergency call-out charge £24.50 Emergency call-out charges: Labour and travelling (subject to agreement) £66.32 per hour evaluation no 362, May 1998 4Ohmeda Care Plus 4000 PRODUCT SUPPORT (Cont'd) Basic Support Contract Four planned preventative maintenance visits per year. Does not include parts. £250.92 Emergency call-out charge £49.00 Emergency call-out charges: Labour and travelling (subject to agreement) £66.32 per hour Non-contract charges Call-out charge £98.00 Labour and traveling £100.00 per hour ‘Spare parts spares availability 7 years Cost of Options/Accessories continuous mattress tit (retro-itted) £790 servo-controlled humidity (retro-fitted) £1,530 servo-controlied oxygen £1,615 in-bed weighing scales £1,995 ‘monitor shelf £200 storage module e415, WV pole e110 reusable skin probe £40 air-intake filters (2) 23.12 oxygen fuel cells £133.90 15 evaluation no 362, January 1998Ohmeda Care Plus 4000 RESULTS TABLE Electrical safety earth leakage current pass {PASS < 1000 yA) Patient leakage current pass (PASS < 1000 pA) Airtemperature control air temperature rise time pass (PASS < 15 min) 5 air temperature overshoot pass ~ (PASS < 2°C) air temperature stability pass (PASS < 0.5°C) air temperature uniformity pass (PASS < 1.0°C) difference from control temperature pass {PASS < 1.5°C) incubator warm-up time pass Baby-temperature control difference from contro! temperature pass (PASS < 0.7°C) Accuracy of temperature displays air temperature pass* skin temperature pass Safety systems’ max. air temperatures wv in air-temperature controlled mode 40°C in baby-temperature controlled mode 38°C with failure of primary sensor pass fan failuret pass Gs, skin sensor failure* pass mains power failure pass auditory alarms (PASS > 65 dB(A) pass Baby compartment environment noise, normal operation pass {PASS < 60 dB(A)) noise, alarm conditions pass (PASS < 80 dB(A)) evaluation no 362, May 1998 16Ohmeda Care Plus 4000 RESULTS TABLE (Cont'd) ‘carbon dioxide washout not tested alr velocity not tested (PASS < 0.35 mvs) max relative humidity with Servo Controlled Humidity option* 80% Construction mobility” ‘good © | mene construction® ‘good serviceability’ ‘good/excellent Reliability faults on delivery none © nus’ user instructions ‘good servicing information excellent Notes: 1. At maximum set temperature 2, See Main Report 3. ‘pass’ implies that the incubator also tums of the heater. 4. At control temperature: 39°C; room temperature: 20.2°O; room RH: 52% 5. Scale used: excellent good/satistectory/poorlunacceptable, 7 evaluation no 362, January 1998Ohmeda Care Plus 4000 Figure 1: Ohmeda Care Plus 4000 Clinical Score Bar Chart Excotent 7 ‘ams PolentNea Medical ——Nung——_—Supler Procedres Procaduee —Treing Figure 2: Effects of opening hand port doors and front access door on air temperature g Alr Temperature/*C & @ al bk e|—— B a a 4Ports open ‘Access door open I ol ao = Time/minutes evaluation no 362, May 1998 18Ohmeda Care Plus 4000 Relative Hurnidity/% e f e Figure 3: Actual relative humidity for various relative humidity control settings 0 «4 {jt | 750 m0 oo 0 00 380 | (Control 40% RA] 0 10 20 9 4 BD 60 7 6 Ww 100 110 120 190 140 100 160 170 180 100 200 210 720 Timefminutes: Figure 4: Effects of opening hand port doors and front access door on relative humidity Ral rami cone E Incubator ar mgeraire: 36°C || 2 f Heri 81% i Room temperate: 29°C al . ft “ ° | = f 1 » = | F . Ports open l |Accees door open cree twuuwunuMamnuNxnuaueunnnne Time/minutos. 19 evaluation no 362, January 1998Ohmeda Care Plus 4000 APPENDIX 1: HOW TO BUY WITH CONFIDENCE. Current production Please note that, because a manufacturer or supplier might continue to modify a product after commenting on our report, the version you buy might differ from the one we evaluated. You are strongly advised to check this with your supplier. Compliance with standards You should give preference to products which elther carry CE marking or comply with the standards covering the safety of medical electrical equipment (BS 5724,lEC 601 or EN 60601). If the product we tested failed to comply with BS 5724, we will have listed the points of non-compliance in the Compliance with Standards section of this report. To find out whether any have been rectified in current production, you should refer to the Manufacturer's Comments section, or contact the manufacturer or supplier. _J2 2° APPENDIX 2: STANDARDS USED FOR TESTING Technical Standards The Technical performance and safety assessments in this issue were carried out for Ohmeda by BSI, Heme! Hempstead and in the evaluation centre at the Cardiff Medicentre. Supplementary testing was also carried out at the Cardiff evaluation centre. For this evaluation, two samples were assessed: one by BSI, the other at Cardiff. The conclusions are therefore based on the assumption that the samples tested were typical of normal production. Safety BSI, Hemel Hempstead, is one of a number of notified bodies in Europe capable of testing medical devices to the appropriate safety standards. An Electromedical Laboratory of BSI tested a unit, at 240 V, ‘against the following Intemational Standards to assess the technical safety aspects of the equipment: IEC 601-1 Medical Electrical Equipment Part 1 1988 General Requirements for safety (Equivalent to BS| 5724 Part 1 1989). IEC 601-2-19:1990 Medical Electrical Equipment: Specification for nursing incubators (Equivalent to BS. 5724: Section 2.119:1991). Performance Similarly, at Cardiff we assessed the product against an evaluation centre benchmark protocol produced for the evaluation programme. Assessment against the protocol was carried out by the staff at the evaluation centre (See Acknowledgements). User Evaluation User assessments were carried out in a selected NHS Trust Hospital (See Acknowledgements). The protocol used for the user trials was devised in cooperation between the evaluators, the clinicians involved] in the user trials and the Department of Health. evaluation no 362, May 1998 20Ohmeda Care Plus 4000 APPENDIX ‘THE MEDICAL DEVICES DIRECTIVE UK regulations implementing this Directive (93/42/EEC) came into force on 1 January 1995 through Statutory Instrument No 3017. The regulations allow for a transition period until 13 June 1998, during which time either the controls existing on 31 December 1894 or the new regulations may be followed. From 14 June 1998 all medical devices (apart from active implantable and in vitro diagnostic medical devices, for which separate regulations apply) marketed in the European Union must comply with the new regulations for medical devices. CE Marking Manufacturers indicate that medical devices are in compliance with the regulations by affixing a °CE” Marking to either the davice itself or the packaging. For many types of devices the CE Marking can be affixed only after approval has been given by an independent certification organisation (Notified Body) Essential Requirements The regulations set out “Essential Requirements” which medical devices must meet in order not to compromise the health or safety of the patient, user or any other person, taking into account any associated risks. Its the duty of the manufacturer to ensure that these Essential Requirements are met, and this may be achieved by manufacturing under a quality system, by type testing, by sampling, or by using a mixture of these manufacturing controls. Standards Application of standards will help manufacturers and Notified Bodies to judge whether the Essential Requirements have been met. Since the Directives cover a wide range of products, involving many levels and types of technology, the Essential Requirements can only provide a broad approach in setting the targets that manufacturers must meet. The European Commission, therefore, has mandated the European standards organisations to prepare European standards to address the Essential Requirements. These standards will assist manufacturers by setting out objective definitions of what the necessary requirements are for particular products, and practical means for manufacturers to show that their products comply with the Essential Requirements. They will, therefore, help to eliminate potential difficulties which otherwise may be experienced by industry when asked to provide justification for claims of compliance with the Essential Requirements. Manufacturers may need to refer to more than one standard in order to address the relevant Essential Requirements pertinent to a given medical device. European standards, mandated by the European Commission, that are accepted as addressing identified Essential Requirements in a Directive are listed in the Official Joumal of the European ‘Communities and are known as harmonised standards. Products manufactured in line with such standards will be presumed to comply with the relevant Essential Requirements. Manufacturers may choose whether or not to apply relevant harmonised standards. In practice, however, compliance with these standards will be the easiest way of showing that their products meet the Essential Requirements. Since the application of harmonised standards will be voluntary, manufacturers may choose altemative methods of demonstrating compliance with the Essential Requirements. For example, manufacturers may Use international, national or in-house standards, These allemative routes may also be used where harmonised standards do not exist for a particular product or Essential Requirement(s). 24 evaluation no 362, January 1998Ohmeda Care Plus 4000 APPENDIX 3 (Cont'd) Directives Bulletins ‘The Medical Devices Agency has produced a number of Directives Bulletins which provide guidance on various aspects of the new regulations. Copies can be obtained from: Mrs C Bantock Medical Devices Agency Hannibal House Elephant & Castle London ‘SE1 6TQ Tel: 0171 972 8090 Fax: 0171 972 8112 No.2 The CE Mark No.3 The Vigilance System and Update on the Directives No.4 Conformity Assessment Procedures No.5 Pre-cinical Assessment Procedures and the Product Registration Scheme No.6 The Notified Body No.7 The Competent Authority No.8 Information about the EC Medical Devices Directives No.9 The Citizen's Charter and Deregulation. A Code for Enforcement No.10 The Classification Rules No.11 EC & EFTAMember States No.12 Sale and Supply of In Vitro Diagnostic Medical Devices No.13 Standards No.14 Compliance Cost Assessments No.15 The Medical Devices, Electromagnetic Compatibility and Low Voltage Devices No.16 Information about the Packaging and Packaging Waste Directive No.17 Medical Devices and Medicinal Products No.18 Activities of Healthcare Establishments (Inhouse Manufacture) in the U.K. No. 184. The Medical Devices Regulations: Implications on Healthcare and other related establishments No.19 Own Brand Labelling and Rental products. ACKNOWLEDGEMENTS, This report was prepared by Dr C J Hacking of the Medical Physics and Clinical Engineering Directorate, University Hospital of Wales Healthcare NHS Trust. The MDA thanks the following members of the Medical Physics and Clinical Engineering Directorate, University Hospital of Wales, Cardiff for their work on this evaluation; Dr C J Hacking, BSc PhD, Centre Supervisor Mr J P McCarthy, BSc MSc CEng MIEE FIPEMB, Consultant Physicist ‘The MDA also thanks Dr D G Spendley for his work on this evaluation, prior to taking up a new position in industry. We also thank the following consultant for his cooperation and assistance in carrying out the user evaluation: Dr J Mooreratt, East Glamorgan General Hospital, Church Village and all the medical, nursing and theatre staff who helped in the evaluation; and the Media Resources ‘Centre, University Hospital of Wales, for the photographic work. ‘evaluation no 362, May 1998 22Ohmeda Care Plus 4000 OTHER REPORTS ON NURSING INCUBATORS. PREVIOUS REPORTS Previous reports on nursing incubator systems still available to the NHS include: 39 Engments Guardian 2000 218 Air-Shields —_Isolette C5500T 70 Ohmeda Care Plus 280 Air-Shields _Isolette C550QT-XL. 129 Draeger 8000 339. UK Market-Product 135 Review Issue 3 Models Review 4 Models 164 EME ‘Atom V850-W 962 Ohmeda Care Plus 4000 172 AirShields — C100QT-EC ENQUIRIES. For information on the evaluation of nursing incubators, please _contact:~ Peter Oddy, Medical Devices Agency, Hannibal House, Elephant and Castle, London SE1 6TQ (direct tel: 0171 972 8155) or via the switchboard on 0171 972 8000. Customers can obtain individual reports from the Ordering Department, Medical Devices Agency, Room 1207, Hannibal House, Elephant and Castle, London SE1 6TQ (Fax: 0171 972 8105). Price information is available from the general enquiry point on 0171 972 8181. Individual reports over three years old are subject to availabilty. For advise on surgical diathermy please contact: Dr Chris Hacking, Medical Devices Evaluation, Cardiff Medicentre, Heath Park, Cardiff, CF4 4UJ, direct tel: 01222 682120, switchboard 01222 757744, email: chris. hacking@ uhr-tr.wales.nhs.uk © CROWN COPYRIGHT 1998 ‘Apart from any fair dealing for the purpose of research or private study, or criticism, or review, as permitted under the copyright, Design & Patents Act, 1988, this publication may only be reproduced, ‘stored or transmitted in any form or by any means with the prior permission, in writing, of the Controller of Her Majesty's Stationery Office (HMSO). Enquiries concerning reproduction outside those terms should be sent to HMSO at the undermentioned ‘address: The copyright Unit, Her Majesty's Stationery Office, St Clemants House, 2-16 Colegate, NORWICH, NR3 180. 23 evaluation no 362, May 1998Distribution DISTRIBUTION ‘This report could improve safety and reduce costs ‘Acopy should be placed in all hospital and health authority libraries. In addition, all major users of this type of equipment, and all staff involved in its selection, maintenance and purchase, including the departments and professions marked below, should be made aware of this issue. ‘Accident & Emergency ‘Materity/Midwitery # “Ambulance Officers Medical ‘Anaesthetics Medical Physics # ‘Audiology Neonatal Units # Cardiac and Coronary Care Nursing # Cardiology Obstetrics & Gynaecology # Glinical Nutrition Units Paediatics # Dental Pharmacy Dermatology Physiotherapy Dialysis Units Radiology Dietitians Fional Services Managers ECG Departments Renal Units Electronic Engineering Rheumatology Engineering Scientific Officers # Family Health Service Authorities ‘Supplies Officers Home Dialysis Administrators Surgical HOSPITAL LIBRARIES Theatre Staft HEALTH AUTHORITY LIBRARIES ‘Transplant Units Intensive care/Therapy ‘Works Officers # ‘Evaluation’ HOW TO OBTAIN COPIES ued by Medical Devices Agency, Scottish Health Care Supplies, Welsh Office and Department of Health and Social Services (Northem Ireland). If you wish to see ‘Evaluation’ regularly, you should talk to your Chief Executive's or General Manager's office about the possibilty of being included on their local distribution list. Copies should be available in your hospital or health authority library. If your library does not receive copies, please first check that itis on the local distribution list. If there is stil a problem, please ask your library to contact the Medical Devices Agency (Tel: 0171 972 8181) Further copies of individual issues for health authorities can be obtained from the following: England: Northern ireland: Scotland: Wales: Medical Devices Agency Defect Centro ETB Sippot Severs Group, Welsh Ofice ‘Orders Deparment Estate Senices Directorate Room DO73A, Heath Services and Room 1207 Heath Estates Seotish Health care Management 1 DWision Hannibal House ‘Sioney Road Supplies Catays Park Etophant and Casto Dundonaic “Tenty Park House Carat CF1 SO London SE1 6TO Bolast BT16 OUS South Tinty Road “al: 01222 829641 Tol-0171-972 8 ‘ak 01232 525714 Eginburgh EHS 33H ‘Tot 0131 581 8008, Ifyou are not an NHS employee, you can purchase ‘Evaluation’. Further information can be obtained by calling 0171 972 8181. evaluation no 362, May 1998 24 ISSN 0960-5843 119005 MDA 9600 1P MAY 98 (ABB)