T34 Directions for Use (3rd Edition) Rev 04

T34™ Syringe Pump (3rd Edition) 

The information in this document is subject to change and does not represent a commitment on the part of Caesarea Medical Electronics Ltd. to provide additional services or enhancements. The screens illustrated in the document are for reference purposes only and might be different than the screens displayed on your pump. Documentation provided with this product might reference product not present in your facility or not yet available for sale in your area. BD, CME, CME logo, Plastipak, and T34 are trademarks of Becton, Dickinson and Company or its affiliates. All other trademarks are the property of their respective owners. ©2019 BD. All rights reserved.

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Contents

Page Section 1: General Information... 4 1.1 Preface... 4 1.2 About this Directions For Use... 4 1.3 Advisory Terms and Warnings... 5 1.4 Intended Use... 7 1.5 Contraindications... 7 1.6 System Symbols... 7 1.7 Syringe Pump Inspection and Unpacking... 9 1.8 Syringe Pump Specifications... 10 Section 2: Disposables and Accessories... 13 2.1 Syringe Brands and Sizes... 13 2.2 Syringe Extension Sets... 14 2.3 Battery Power Supply... 16 2.4 Lockbox (Optional)... 18 2.5 Carry Pouches (Optional)... 18 Section 3: Pump Features and Description... 19 3.1 Overview... 19 3.2 Pump Description... 19 3.3 Event Log... 22 3.4 Post Occlusion Bolus Reduction System (POBRS)... 23 Section 4: Modes of Operation... 24 4.1 Modes of Operation... 24 Section 5: Pump Configuration... 27 5.1 Pump Configuration... 27 5.2 Pump Access Codes... 27 5.3 Pump Info and Configuration Menus... 28 5.4 Pump Configurable Settings for Modes of Operation... 30 5.5 Optional Configurable Settings... 31 5.6 Practice Scenarios for Changing Pump Configuration... 33 Section 6: Starting A New Infusion... 37 6.1 Sequence for Starting an Infusion... 37 6.2 Releasing a Trapped Foreign Object from the Actuator... 43 Section 7: Monitoring and Managing Infusions... 44 7.1 Pump and Infusion Safety Checks... 44 7.2 Keypad Lock... 46 7.3 Program Protection and Resume... 47 7.4 Stopping/Pausing the Infusion and Powering Off... 48 7.5 Alerts, Alarms and Troubleshooting... 49 7.6 Bolus... 51 7.7 Changing Syringes/Syringe Extension Sets... 52 Section 8: Servicing and Maintenance... 53 8.1 Servicing, Maintenance and Periodic Checks... 53 8.2 Cleaning... 54 8.3 Pump Storage... 55 8.4 Disposal/Decommissioning... 55

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Section 1: General Information

Section 1: General Information 1.1 Preface Duplication or distribution of this Directions For Use and any information contained within is strictly prohibited without the express written permission of CME Ltd. This Directions For Use and any information contained within, may not be reproduced, distributed, or transmitted in any form, or by any means, for any purpose, without the express written permission of CME Ltd. To order additional copies of this Directions For Use , or other related manuals, contact your BD representative. The information in this Directions For Use has been carefully compiled, and is believed to be entirely reliable. However, no responsibility is assumed for inaccuracies. Furthermore, CME Ltd. reserves the right to make changes to any products herein to improve readability, function, or design. CME Ltd. does not assume any liability arising out of the application or use of any product described herein; neither does it cover any license under its patent rights nor the rights of others.

1.2 About this Directions For Use The operator must be thoroughly familiar with the T34™ Syringe Pump described in this Directions For Use prior to use, and in particular must read and understand any warnings and precautions stated herein. All illustrations used in this Directions For Use show typical settings and values that may be used in setting up the functions of the syringe pump. These settings and values are for illustrative use only. The complete range of settings and values are listed in the specifications section of this Directions For Use. This Directions For Use has been developed with consideration to the requirements in relevant Harmonised Standards. Data presented in the technical specifications reflect specific test conditions defined in this standard. Other external factors such as varying back pressure, temperature, head height, syringe extension set usage, fluid restrictions, solution viscosity or combinations of these factors, may result in deviations from the performance data enclosed. Note: Keep this Directions For Use for future reference during the syringe pump's operational life.

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1.3 Advisory Terms and Warnings WARNINGS, CAUTIONS AND NOTES Warnings, cautions and notes will be seen throughout this Directions For Use. These are defined as follows: Warnings advise of circumstances that could result in injury or death to the patient or operator. Read and understand this Directions For Use and all warnings completely before operating the T34™ Syringe Pump. Cautions advise of circumstances that could result in damage to the T34™ Syringe Pump. Read and understand this Directions For Use and all cautions completely before operating the T34™ Syringe Pump. Note: A Note indicates that the information that follows is additional important information, a tip that will help you recover from an error or refer you to related information within the Directions For Use.

OPERATING PRECAUTIONS AND WARNINGS Read the entire Directions For Use before using the syringe pump, since the text includes important precautions.

Only trained service personnel should open the syringe pump cover.

A kinked or occluded syringe extension set may impair the operation of the syringe pump and the accuracy of the infusion. Before operation, verify that the syringe extension set is not kinked or occluded. Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied or recommended by the T34™ Syringe Pump distributor. Do not use this equipment with other infusion systems or accessories that are not designed to be used with this pump system. Do not let the syringe pump operate when battery is fully depleted. Pump may turn off during operation on fully depleted battery. Before beginning infusion, ensure the battery is fully charged. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the T34TM Syringe Pump, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Although the T34™ Syringe Pump has been designed and manufactured to exact specifications, it is not intended to replace trained personnel in the supervision of infusions. The specified accuracy of the syringe pump can only be maintained if the syringe pump is used in accordance with the Directions For Use and is maintained and serviced by a certified CME technician. Adjustments, maintenance, or repair made by un-certified service personnel may impair the operation of the syringe pump and/or the accuracy of the infusion. Make sure any adjustments, maintenance, or repair of the syringe pump are carried out only by authorised and skilled technicians. Refer all service, repair and adjustments only to qualified and certified technical personnel. Unauthorised modifications or the use of any spare parts, other than those supplied by the manufacturer or their distributor, will void any warranty. DFU999-103EN Rev. 04

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If the syringe pump is subjected to excessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by qualified personnel. The syringe pump has been designed to be as safe as possible to handle; however, care should be exercised to avoid trapping of fingers or other body parts in the mechanism. The T34™ Syringe Pump should be operated within the recommended environmental operating range. Operation at temperatures and/or humidity outside this range may adversely affect accuracy. This syringe pump is designed for use and should withstand everyday handling. If the syringe pump is dropped onto a hard surface, or is suspected of being dropped, the operation and calibration should be checked by a qualified technician. Pump should be stored with the battery removed to prevent battery corrosion and decay.

CME Ltd. will assume no responsibility for incidents which may occur if the product is not used, stored or transported in accordance with the environmental conditions stipulated in this document or on the package labelling.

INFUSION PRECAUTIONS AND WARNINGS Carefully read and follow accompanying syringe extension set instructions for priming the set and the recommended set change interval. The syringe and syringe extension set should be disposed of in an appropriate manner, considering the nature of the residual fluid that may be contained within and in accordance with the hospital/homecare provider's disposal practices. Drugs for infusion to be used with the syringe pump may only be prescribed by a qualified medical practitioner. Caution must be exercised in the selection of drugs and the amount and rate intended to be delivered via syringe pump. If the drug contained in the syringe will be exposed to extreme environmental conditions for prolonged time periods, it is important to select drugs that will not change pharmacologically upon such exposure. As with all automatic syringe pumps, whenever a toxic or dangerous level of drug is stored in the reservoir, constant/frequent monitoring of the infusion is required. In all applications, time to alarm under occlusion or other fault conditions will depend on the infusion rate and levels of alarm settings. It is recommended to consider these parameters when using drugs requiring infusion stability or low flow rates and therefore a quick time to alarm. Do not use Slip-tip syringes. Luer Lock syringes must always be used to ensure secure connection of the syringe extension set and the syringe pump.

GENERAL PRECAUTIONS AND WARNINGS The maximum volume that may be infused under single fault condition is 0.1 ml.

Potential strangulation may occur if the cables/tubing are of excessive length.

Potential choking may occur if small parts are inhaled or swallowed.

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Potential allergic reactions may occur due to materials used in the syringe pump.

The T34™ Syringe Pump is not certified for use in oxygen-enriched environments.

Do not operate the syringe pump near high-energy radio-frequency emitting equipment, (e.g. Imaging equipment (i.e., X-Ray, MRI, CT Scan, etc.), High Frequency (RF) Surgical Equipment, Defibrillator, etc.) as this may cause degradation in performance of the syringe pump, which may affect proper infusate delivery. Do not use hard or sharp objects on the keypad.

Do not bathe or shower whilst using the syringe pump. The syringe pump is resistant to a limited amount of splashing, but its construction does not make it resistant to large amounts of spraying or immersion in liquids. Damage to the internal components may result.

1.4 Intended Use The T34™ Syringe Pump is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, Immunoglobulins, biosimilar, chemotherapeutic agents and general fluids therapy in hospital and homecare environments.

1.5 Contraindications • • • •

Infusion of blood and blood products Infusion of insulin Infusion of critical medications whose stoppage or interruption could cause serious injury or death Use in ambulatory regimens by patients who do not possess the mental, physical or emotional capability to self-administer their therapy, or who are not under the care of a responsible individual

1.6 System Symbols The following symbols are used on the T34™ Syringe Pump and components. Labels on the syringe pump or statements in this Directions For Use preceded by any of the following words and/or symbols are of special significance and/or are intended to help you to operate the syringe pump in a safe and successful manner.

System Symbol Identification and Description Symbol

Description Syringe Pump

Warnings advise of circumstances that could result in injury or death to the patient or operator. Read and understand this Directions For Use and all warnings completely before operating the T34™ Syringe Pump.

Cautions advise of circumstances that could result in damage to the T34™ Syringe Pump. Read and understand this Directions For Use and all cautions completely before operating the T34™ Syringe Pump. Refer to Directions For Use: Read the entire Directions For Use before using the syringe pump.

CE mark indicates conformance to Medical Device Directive 93/42/EEC.

Do not dispose of in municipal waste. Symbol indicates separate collection for electrical and electronic equipment. (WEEE Directive 2012/19/EU). NOTE: Does not apply to the battery.

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Type CF applied part.

Class II Medical Electrical Equipment providing double insulation for operator and patient safety.

IP22

Symbol for degree of protection against ingress of water and solid objects.

Battery.

Direct current.

Manufactured by.

Date of manufacture.

Serial number.

Reference number. Indicates the manufacturer's catalogue number so that the medical device can be identified.

Indicates the authorised representative in the European Community.

Indicates the acceptable upper and lower limits of atmospheric pressure (altitude).

Indicates the acceptable upper and lower limits of relative humidity.

Indicates the range of temperatures to which the medical device can safely be exposed.

Indicates a medical device that should not be used if its packaging has been damaged or opened.

Indicates the number of drops per millilitre.

Disposables The use of single-use disposable components on more than one patient is a biological hazard. Do not reuse single-use disposable components.

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Expiry date (consumables).

Lot number (consumables).

Sterilized with Ethylene Oxide (applies to syringe extension sets).

1.7 Syringe Pump Inspection and Unpacking INSPECTING THE SYRINGE PUMP BEFORE USE Remove the T34™ Syringe Pump from the packaging and inspect for damage during shipment or storage. Make sure you have the following items: • T34™ Syringe Pump • Directions For Use • Quick Reference Guide for homecare If any items are missing or damaged, contact your supplies department. Visually inspect packaging and contents before each use.

Do not use the T34™ Syringe Pump and accessories if there are any obvious signs of damage. Return for inspection by authorised service personnel.

ACCESSORIES (IF PURCHASED) • Lockbox (supplied with two keys) • Carry Pouch (re-usable or disposable) Refer to the product catalogue for more details. If any items are missing or damaged, contact your supplies department. Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied or recommended by the T34™ Syringe Pump distributor.

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1.8 Syringe Pump Specifications T34™ SYRINGE PUMP SPECIFICATIONS Type:

Flow Rate:

Linear syringe driver mechanism, pulsed motion (540 pulses per mm). Flow rate is adjustable between 0.1 ml/h and 650 ml/h

0.1–10 ml/h in 0.01 ml/h increments; 10–29.9 ml/h in 0.1 ml/h increments; 30–49.5 ml/h in 0.5 ml/h increments; 50–299 ml/h in 1 ml/h increments; 300–650 ml/h in 5 ml/h increments.

Bolus flow rate 1–650 ml/h: Bolus Parameters:

1–10 ml/h in 0.01 ml/h increments; 10–29.9 ml/h in 0.1 ml/h increments; 30–49.5 ml/h in 0.5 ml/h increments; 50–299 ml/h in 1 ml/h increments; 300–650 ml/h in 5 ml/h increments.

Bolus volume: 0–20 ml in 0.1 ml increments. Maximum bolus volume is 20 ml.

Actuator Travel:

67 mm available.

Syringe Sizes:

2 ml to 50 ml (most commonly used manufacturers). ± 5% system accuracy (syringe pump and set combined) by volume under nominal conditions, defined as follows:

Accuracy:

Flow rates: 1 ml/h and 5 ml/h; Tested with syringe extension set model M100-172SB; Needle: 18 gauge; Solution Type: Distilled water; Temperature: 22°C ± 3°C; Back Pressure: 0 ± 10 mmHg; Syringe size and brand: BD Plastipak 20 ml. Accuracy measured using the trumpet curve test method defined in EN/IEC60601-2-24.

Occlusion Pressure:

200–1500 mmHg configurable (10 mmHg increments).

Battery:

9 V alkaline, IEC 6LR61 type.

Operating Time:

Rate

Approximate battery life

1 ml/h

25 hours

5 ml/h

20 hours

Indicators:

4 line LCD display (122 × 32 pixels), dual color operation LED.

Alarms:

When a problem is detected, the T34™ displays the following alarm messages, sounds an audible alarm and the LED lights red: Occlusion or Syringe Empty

Syringe Displaced during infusion

End Program

System Error

End Battery Dimensions:

167 × 68 × 39 mm (L x W x H) Type CF Equipment, degree of protection against electrical shock; IP22 protection against ingress of water and solid objects. Definition of code:

Classification:

I = Ingress P = Protection 2 = Protection from solid objects ≥12.5 mm 2 = Protection from dripping water (15° tilted)

Housing:

ABS (fire retardant). Complies with standard UL94V-1.

Weight:

230 g without battery.

Electrical Safety:

Complies with: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24.

Standards:

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Manufactured in accordance with ISO 13485, IEC 62304 and IEC 62366. CE marked in accordance with the Medical Devices Directive 93/42/EEC.

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Environmental Specifications:

Operating Environment Range: Ambient Temperature: 5°C to 40°C Relative Humidity: 15% to 90%, non-condensing Ambient pressure: 70 kPa to 106 kPa. Transport and Storage Conditions: Ambient Temperature: −25°C to 70°C Relative Humidity: 0% to 90%, non-condensing Ambient pressure: 48 kPa to 110 kPa. The T34™ Syringe Pump is designed to be in compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-24 (infusion pump).

EMC Specifications:

The T34™ Syringe Pumps have been tested and found to comply with the limits for a Class B digital device. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. The T34™ Syringe Pump has been tested to comply with the requirements of IEC 60601-1-2:2014.

EMC – Emissions Compliance

EMC Standard

Range

Compliance

Radiated emissions

CISPR 11:2015

30 MHz – 1 GHz

Class B, Group 1

EMC – Immunity Compliance

EMC Standard IEC 61000-4-2

Electrostatic Discharge (ESD) Immunity

Radiated RF Immunity

Proximity fields from RF wireless communications equipment

IEC 60601-2-24

Test level

Compliance

Contact discharge

± 2 kV, ± 4 kV, ± 6 kV

Air discharge

± 2 kV, ± 4 kV, ± 8 kV

Contact discharge

± 8 kV

Air discharge

± 15 kV

IEC 61000-4-3:2006 +A1:2007 +A2:2010

IEC 61000-4-3:2006 +A1:2007 +A2:2010

No degradation of performance Operator intervention may be required as the syringe pump may intermittently reset, requiring user to restart the infusion.

10 V/m Yes

80 MHz – 2.7 GHz 80% AM at 1 kHz 380 – 390 MHz

27 V/m

430 – 470 MHz

28 V/m

704 – 787 MHz

9 V/m

800 – 960 MHz

28 V/m

1.7 – 1.99 GHz

28 V/m

2.4 – 2.57 GHz

28 V/m

5.1 – 5.80 GHz

9 V/m

Yes

3 V/m 0.15 MHz – 80 MHz Conducted RF Immunity

IEC 61000-4-6:2013

6 V/m in ISM and amateur radio bands between 0.15 MHz and 80 MHz

Yes

80% AM at 1 kHz Power Frequency Magnetic Field Immunity

IEC 61000-4-8:2009

30 A/m 50 Hz

Yes

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

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Use of accessories other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Do not operate the syringe pump near high-energy radio-frequency emitting equipment, (e.g. Imaging equipment (i.e., X-Ray, MRI, CT Scan, etc.), High Frequency (RF) Surgical Equipment, Defibrillator, etc.) as this may cause degradation in performance of the syringe pump, which may affect proper infusate delivery. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the T34TM syringe pump, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

PUMP ACCURACY The following graphs and curves were derived from testing described in IEC60601-2-24. Testing was performed under normal conditions at room temperature (72°F or 22°C). Any deviations from normal conditions and room temperature may cause changes in the accuracy of the syringe pump.

Start-up Curves The Start-up curves represent continuous flow versus operating time for two hours from the start of the infusion, measured for infusion rates of 5 ml/h and 1 ml/h. They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity. Trumpet curves are derived from the second hour of this data. Tests performed according to IEC 60601-2-24 standard. T34™ Long Term Rate Long Term RateAccuracy Accuracy at 5 ml/h

T34™ Long Term Rate Long Term RateAccuracy Accuracy at 1 ml/h

10.00

2.00

9.00

1.80 1.60

7.00

Rate (ml/h) Rate (ml/h)

Rate (ml/h) Rate (ml/h)

8.00 6.00 5.00 4.00 3.00 2.00 1.00 0.00

1.40 1.20 1.00 0.80 0.60 0.40 0.20

0

20

40

60

80

100

0.00

120

0

20

40

Time (min)

60

80

100

120

Time (min)

Time (min)

Time (min)

Trumpet Curves With the T34™, as with all infusion systems, variations cause short term fluctuations in rate accuracy. The following curves show typical performance of the system in two ways: 1. The accuracy of fluid delivery over various time periods is measured (trumpet curves). 2. The delay in onset of fluid flow when infusion commences (start up curves). Trumpet curves are named for their characteristic shape. They display discrete data averaged over particular time periods or 'Observation windows', not continuous data versus operating time. Over long observation windows, short-term fluctuation has little effect on accuracy as represented by the flat part of the curve. As the observation window is reduced, short-term fluctuations have greater effects as represented by the 'mouth' of the trumpet. Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered. Short-term fluctuations in rate accuracy may have clinical impact depending on the shelf life of the drug being infused and the degree of inter-vascular integration. The clinical effect cannot be determined from the trumpet curves alone. T34™ Trumpet Curve at 5 ml/h

T34™ Trumpet Curve at 1 ml/h

T34 Trumpet Curve at 1ml/h

4 3

3.03

2

1.83 1.02

1

0.64

0.48

0.36 0.257

0 -1

-2.84

-3 -4

0.02

-0.15

-1.39-0.49

-2

0.09

0

5

10

15

20

Observation Interval (min) Observation interval (min)

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25

30

35

FlowFlow rate (%) Rateerror error (%)

FlowFlow rate (%) Rateerror error (%)

T34 Trumpet Curve at 5ml/h

15 10.89

10

6.44

5

2.59

1.56

0.95

0.69

-0.77

-0.15

0.13

0.397

0 -4.84-1.99

-5 -10

-8.05 0

5

10

15

20

25

30

35

Observation Interval (min) (min) Observation interval

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Section 2: Disposables and Accessories 2.1 Syringe Brands and Sizes The T34™ Syringe Pump is programmed to recognize most commonly used syringes from 2 ml to 50 ml. Luer Lock syringes should always be used to ensure secure connection of the syringe extension set and syringe. To avoid accidental selection of an incorrect brand of syringe during setup, it is recommended to disable all syringe types not in regular use. Unused syringe types can be disabled by an authorised technician. Do not use Slip-tip syringes. Luer Lock syringes must always be used to ensure secure connection of the syringe extension set and the syringe pump. Should you need to operate the T34™ Syringe Pump with a syringe manufacturer and/or brand other than those listed here, please consult either your local medical engineering department or CME Ltd. Technical Services.

Default Syringe Brands Configured for Use with T34™ Manufacturer Braun Omnifix

Syringe Sizes (ml) 2

5

10

20

30

50 50

BD Plastipak

3

5

10

20

30

Monoject

3

6

12

20

35

10

20

30

50

Codan/Once Terumo

5

10

20

30

50

Nipro

5

10

20

30

50

Syringe Volumes Due to the physical length of the screw that drives the syringe plunger forward there are limits to the maximum amount of infusate that can be delivered from larger syringes and on some smaller syringes there is an undeliverable volume of infusate that will remain in the syringe once the actuator has driven to the zero position. Braun 2 ml, BD 10 ml, Codan 10 ml, Monoject 3 ml, Monoject 12 ml, Monoject 35 ml, Nipro 10 ml and Nipro 20 ml syringes cannot empty completely, potentially a small volume of infusate will be left in the syringe due to limitations of the syringe pump and the syringes design. The T34™ Syringe Pump will display the volume as, for example, Vol 5 (of 5.2)ml. In this example the syringe pump can only deliver 5 ml of the 5.2 ml in the syringe and when the syringe pump has driven the syringe plunger as far forward as possible, 0.2 ml will remain in the syringe. The potential volumes that might remain in the syringes are listed in the table below: Syringe size and brand

Vol 5(of 5.2)ml Change /, Press 

Undeliverable infusate volume

Braun Omnifix

2 ml

0.000 ml to 0.114 ml

BD Plastipak

10 ml

0.000 ml to 0.177 ml

Codan/Once

10 ml

0.000 ml to 0.043 ml

Monoject

3 ml

0.000 ml to 0.007 ml

Monoject

12 ml

0.000 ml to 0.388 ml

Monoject

35 ml

0.000 ml to 0.348 ml

Nipro

10 ml

0.000 ml to 0.094 ml

Nipro

20 ml

0.000 ml to 0.006 ml

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12 ml Monoject

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Some manufacturers have several brand names within their ranges (e.g. Braun Omnifix and Braun Perfusor). Only use the brands named above with the T34™, as failing to do so could result in an under- or over-infusion.

Maximum Fill Volume for Syringes 20 ml to 50 ml Syringe brand

Syringe size 20 ml

30 ml

50 ml

Monoject

18.7 ml

-

-

Braun Omnifix

20 ml

24.4 ml

37.7 ml

BD Plastipak

18 ml

23.5 ml

34.9 ml

Terumo

18.6 ml

24.5 ml

38.0 ml

Codan

20 ml

22.5 ml

35.9 ml

Time to Alarm from Occlusion Flow Rate

Pressure Threshold

Time to Alarm (TTA) (hh:mm:ss)

5 ml/h

200 mmHg

TTA < 00:06:00

1 ml/h

200 mmHg

TTA < 00:35:00

0.1 ml/h

200 mmHg

TTA < 06:00:00

5 ml/h

1500 mmHg

TTA < 00:25:00

1 ml/h

1500 mmHg

TTA < 03:45:00

0.1 ml/h

1500 mmHg

TTA < 24:00:00

Note: Tested at flow rates and occlusion thresholds as described in the table above, using a BD Plastipak 20 ml syringe.

2.2 Syringe Extension Sets INTRODUCTION The T34™ Syringe Pump can be operated with any syringe extension set with a Luer connection. However, it is recommended, to optimise system accuracy and performance, that proprietary syringe extension sets from CME Ltd. are used. All CME Ltd. syringe extension sets have siphon/free flow protection.

FEATURES AND CHARACTERISTICS Feature

Description

Materials

The syringe extension sets are manufactured using PVC materials that do not contain latex or di-2ethylhexyl phthalate (DEHP). Micro-bore: require small priming volumes.

Tubing

Anti-kink: to prevent kinking or occlusion particularly in configuration. Various lengths available.

Slide clamp

Clamps: to prevent fluid flow to patient (optional on some syringe extension sets). All CME Ltd. syringe extension sets contain an anti-syphon valve to prevent uncontrolled flow of fluid either into or from the patient.

Pressure activated antisiphon/anti-reflux valve

The syringe extension set with pressure activated anti-siphon/anti-reflux valve reduces the potential for uncontrolled flow and backflow (backtracking). The pressure-activated anti-siphon valve requires pressure to open. The syringe pump occlusion pressure setting may require adjustment to prevent occlusion alarms. The anti-syphon valve enhances pump functioning by: • Preventing siphoning (uncontrolled flow) in the event the syringe extension set is detached from the syringe pump or mechanical malfunction, and • Preventing reflux (back-flow) in the event several infusion pumps are connected simultaneously to the same patient.

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Luer Lock end connector

The syringe extension set is designed to be connected to Luer Lock syringes. Luer Lock syringes allow a connection between male and female Luer. This provides a secure connection and prevents accidental removal.

Ensure the syringe extension set is NOT connected to the patient during priming.

A kinked or occluded syringe extension set may impair the operation and accuracy of the syringe pump. Before operation, verify that the syringe extension set is not kinked or occluded. Note: The recommended syringe extension set change interval is maximum 72 hours.

ADVISORY WARNINGS AND NOTES FOR SYRINGES AND SYRINGE EXTENSION SETS Component damage may occur if the syringe extension set is not correctly attached to the syringe. Assure all connections are secure: Do not over-tighten connection. This will help minimise leaks, disconnection and component damage. Disposables (as with any infusion) used with the syringe pump must be compatible with the drug/fluid being delivered. Check with the manufacturer of the disposables before use. Consult the fluid or drug manufacturer's information for precautions, guidelines, and instructions for preparation and use of disposables. Replace the syringe and/or syringe extension set in accordance with local guidelines.

Use aseptic technique when filling the syringe and priming the syringe extension set. Patient infection may result from the use of non-sterile components. Maintain sterility of all syringe extension set components and do not re-use single-use syringe extension sets. Syringes and syringe extension sets should be disposed of in an appropriate manner, considering the nature of the residual fluid that may be contained within, in accordance with the hospital/homecare provider's disposal practices.

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Section 2: Disposables and Accessories

2.3 Battery Power Supply Refer to section 7.1 for checking battery levels

BATTERY TYPES AND USE Always use a 9 volt alkaline disposable battery with the following attributes: Designation:

IEC: 6LR61

Body Size:

46.4 mm × 26.5 mm × 17.5 mm

Impedance:

1700 milli-ohms @ 1 kHz

Do not use batteries marked 6LP3146 or 6LF22 with the T34™ Syringe Pump. 6LP3146 and 6LF22 batteries can cause issues with the operation of the syringe pump, as the physical construction and internal resistance of this type of battery are different to the 6LR61 battery. Issues arising from use of 6LP3146 and 6LF22 batteries can include End Battery messages during Pre-Load, volume test fails, pressure test/calibration issues and reduced amount of infusions from a battery. Nominal voltage

9V

Impedance

1700 milli-ohms @ 1 kHz

Typical weight

45 g (1.6 oz)

Typical volume

22.8 cm3 (1.4 in3)

Terminals

Miniature snap

Storage temp. range

5°C to 30°C (41°F to 86°F)

Operating temp. range

−20°C to 54°C (−4°F to 130°F)

Designation

ANSI: 1604A

IEC: 6LR61

Note: Tested at flow rates and occlusion thresholds as described in the table above, using a BD Plastipak 20 ml syringe. If a battery is too tight, do not try to force it into the battery compartment as this may damage the battery contacts.

Only use accessories designed for the system. Unsafe operation may result from using improper accessories. Use only accessories and options designed for this system and supplied or recommended by the T34™ Syringe Pump distributor.

BATTERY LIFE Factors that affect battery life include: • Pump settings, • Infusion rate, • The number of interventions that occur (e.g. stopping/starting infusions, manual movement of actuator and backlight activation), • The number of key presses that occur, and • Frequency of LED green light flashing. The syringe pump battery meter displays battery life remaining as a percentage (%). • When the battery power is low a low battery alert will activate. • When the battery power is almost depleted, an end of battery alarm will activate. • The end of battery alarm will continue until the user presses key to confirm or the battery power is fully depleted. Refer to alerts, alarms and troubleshooting section for further information on alerts, alarms and troubleshooting.

INDICATIONS TO CHANGE A BATTERY Guidance for battery changing may vary for different areas according to local policy and where the syringe pump is to be used and who is managing the syringe pump (healthcare professional or patient). If the syringe pump is being managed in an environment where designated personnel are available at all times to change a battery if necessary, the low battery alert can be used as an indication to change a battery. Note: If the syringe pump is being managed in an environment where designated personnel are unavailable to change a battery if necessary, the following rule applies: To ensure delivery of 24 hours at flow rate of up to 1ml/h, always change to a new battery.

BATTERY FITTING AND REMOVAL Inserting and removing a battery The battery should fit securely to ensure good electrical contact.

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Section 2: Disposables and Accessories

DO NOT use scissors or metal objects to remove a battery.

To insert the battery into the syringe pump:

1. Slide the compartment cover off at the back of the syringe pump.

2. This reveals the empty battery compartment, with insertion instructions.

3. Push the battery into the compartment taking care to ensure that the battery + / − contacts are aligned on the label inside the compartment.

4. Slide the cover back on.

To remove the battery from the syringe pump: 1. Slide the compartment cover off at the back of the syringe pump. 2. Remove the battery 3. Slide the cover back on.

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Section 2: Disposables and Accessories

2.4 Lockbox (Optional) USES AND FEATURES Lockboxes are designed to help protect the syringe from displacement and/or tampering. Lock boxes are made from polycarbonate due to its high impact, temperature resistance and optical properties.

TYPES AND SIZES Lockboxes are available in clear plastic. • The clear lockbox can be used with any drug delivery route. • The lockbox will fit most commonly used syringe brands and sizes up to 30 ml. Refer to your local sales representative for any product-related information. After the syringe is loaded on the T34™ Syringe Pump and the syringe extension set is connected, place the syringe pump into the lockbox and carry pouch: 1. 2. 3. 4.

Open the lockbox using the standard key that operates all T34™ Syringe Pump lockboxes. Place the syringe pump into the lockbox so that the LCD display and keypad line up with the cut out opening. Close the lockbox, guiding the syringe extension set out of the slot at the side of the top section of the lockbox. Place the lockbox (or the syringe pump without the lockbox) into the carry pouch and secure to the patient. Note: You can use the lockbox only with syringes which size is 30 ml or smaller. Note: Lockboxes are designed for the use with CME Ltd. syringe extension sets. If using an alternate brand of syringe extension set with a commonly used 30 ml syringe, the syringe extension set design may prevent the lockbox from fully closing and locking.

2.5 Carry Pouches (Optional) CARRY POUCH USE AND TYPES Disposable and reusable (washable) pouches are available. Refer to your local sales representative for any product-related information. Refer to Section 7.7 for re-usable pouch cleaning/washing instructions. Using the syringe pump with a CME Ltd. carry pouch or similar receptacle during transportation or patient ambulation whilst the syringe pump is infusing protects the syringe pump functionality and the medication in the syringe. The carry pouch will also protect the syringe pump from damage or syringe displacement. When using the CME Ltd reusable (washable) carry pouch, it is possible to access the screen and keypad of the syringe pump during infusion by lifting the Velcro flap of the carry pouch whilst the syringe pump remains in the carry pouch. When using either a CME Ltd reusable (washable) or disposable (single patient use) carry pouch it is possible to remove the forward part of the syringe pump during infusion from the carry pouch to inspect the syringe without removing the rear section of the syringe pump. CME Ltd carry pouches can be carried on the shoulder or around the waist for convenience.

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Section 3: Pump Features and Description

Section 3: Pump Features and Description 3.1 Overview The T34™ Syringe Pump provides the following features: • Accommodates a range of commonly used syringe brand and sizes • Three-point syringe detection system • Capable of small ml/h rate delivery • Configurable occlusion pressure setting • LCD display screen with backlight • Green LED indicator light to indicate if infusion is in progress • Event log The following safety features are available: • • • • • •

Access code protected pump configuration Lockable infusion program Post Occlusion Bolus Reduction System Comprehensive range of alerts and alarms Keypad lock Lockable lockbox (optional)

3.2 Pump Description 1. Barrel clamp arm sensor

2. Collar sensor

3. Plunger sensor

6. Guide rails 4. Lead screw

5. Actuator

TOP OF PUMP: SYRINGE FITTING No.

Area

Function

1.

Barrel clamp arm sensor

Detects syringe barrel loading and secures syringe in place.

2.

Collar sensor

Detects correct loading of the syringe collar.

3.

Plunger sensor

Detects correct loading of the syringe plunger.

4.

Lead screw

Moves actuator.

5.

Actuator

Drives the syringe plunger to deliver syringe contents.

6.

Guide rails

The two guide rails support the actuator position.

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Section 3: Pump Features and Description

FRONT OF PUMP: KEYS AND DISPLAY SCREEN Barrel clamp arm sensor

Syringe collar

Syringe plunger Plunger sensor Actuator

10. LCD display screen

1. i+ key (Info menu)

9. LED indicator 8. On / Off key 7. Move Actuator Back 6. Move Actuator Forward, Purge/Bolus feature

2. Up 3. Down 4. Start / OK 5. Stop / No No.

Area

Function

1.

Info Menu key

• • • •

Pressing once during infusion displays an infusion summary. Pressing a second time during infusion displays the current battery level. When pump is in standby mode, accesses the main (Info) menu. Activates/deactivates keypad lock.

2.

Up key

• Scrolls between options. • Increases infusion parameters during programming/titration.

3.

Down key

• Scrolls between options. • Decreases infusion parameters during programming/titration.

4.

Start / OK key

• Confirms selection. • Starts infusion.

5.

Stop / No key

• Takes user back one step during programming. • Stops infusion.

6.

Move Actuator Forward key

• Moves actuator forward when no syringe in place and the barrel clamp arm is down. • Accesses purge function (if enabled). • Accesses bolus function (if enabled).

7.

Move Actuator Back key

• Moves actuator backward when no syringe is in place and barrel clamp arm is down.

8.

On / Off key

• Powers the syringe pump on and off.

9.

LED indicator

• The LED indicator light is a steady green during system self-tests. • The LED indicator flashes green to indicate infusion delivery. • The LED indicator is a steady yellow when the syringe pump is in standby mode or indicates low priority alarm. • The LED indicator flashes yellow to indicate medium priority alarm. • The LED indicator flashes red to indicate a high priority alarm.

10.

LCD display screen

• Displays pump and infusion status, programming choices and instructions.

Note: Instructions on the pump label are for reference only and do not reflect all possible settings. Please, refer to this Directions For Use for full instructions. DFU999-103EN Rev. 04

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