Specifications include, but are not limited to: 1.0 PERSONAL-USE DOUBLE ELECTRIC BREAST PUMP 1.1 Each box must be labeled with the contents identifiable from the outside of the box and the quantity of pump(s) on the exterior of each box. 1.2 The serial number of each pump must be tamper resistant, accessible without complete disassembly of the housing unit, and comply with the FDA Electronic Code of Federal Regulations. 1.3 Within one year of contract implementation, all pumps must be marked with an identifier that uniquely identifies the pump as a WIC-issued pump. 1.4 If applicable, language must be imprinted on the pump or carrying case, specifying that the pump is for a single user only and may present a health risk if used by more than one person. 1.5 The personal use double electric breast pump (personal-use pump) unit must be packaged with a pre-assembled milk collection kit (with or without bottles pre-assembled). 1.6 The personal-use breast pump must have single and double pumping capacities. 1.7 The pump kit must be capable of functioning as a manual pump and must contain all the parts necessary to easily convert to a manual pump. 1.8 The personal-use pump kit must include breast flanges which: Accommodate at least two different sizes within the 24 - 31 mm range, either by providing 2 separate sets of flanges, or 1 set of flanges flexible enough to fit all users within this range. Are free of sharp edges. Are effective and comfortable for users. Additionally, smaller (21 mm) or larger (up to 36 mm) breast flanges must fit the pump kit without the need to purchase additional parts or accessories. 1.9 The personal-use pump kit must include two extra sets of membranes or valves. 1.10 The personal-use pump kit must contain 4 bottles which: Are reusable. Have a minimum four ounce capacity. Are Bisphenol-A (BPA) Free. Include a spill-proof cap which is easy to remove. 1.11 Personal use pump kits must be easy to disassemble and reassemble for cleaning. Parts of the pump that come in contact with milk must: Be easily cleaned with a household detergent and/or home sterilization by boiling water bath, dishwasher and/or steam cleaning. Maintain integrity and functionality after daily sanitation during the specified warranty period. 1.12 Carrying Case must be included and: Securely accommodate the pump-motor assembly and pump kit accessories. Include an insulated compartment, or separate bag, that contains hard, puncture resistant cooling elements and be large enough to store four manufacturer’s bottles. Be made of a sturdy, durable material that allows for surface cleanings. Include a shoulder strap that facilitates carrying the pump. 1.13 The personal-use breast pump unit, with carrying case, must weigh less than 9 pounds, excluding the insulated case and cooling elements. 1.14 The personal-use breast pump unit must not exceed a maximum of -270 mm Hg when used according to the manufacturer’s instructions. A cycle, by definition, must be measured from the beginning of pressure raise (suction), to the beginning of the next pressure raise that reaches the same pressure level. 1.15 The personal-use breast pump must have the ability to create an automatic suction cycle between 30 and 90 cycles per minute during the milk extraction phase. 1.16 The breast milk pathway must be visible and must not allow milk to contact the pump housing unit or internal pump-motor unit at any time when the pump is used per manufacturer’s instructions. 1.17 The personal-use breast pump must contain a suction regulator that allows the individual user to adjust suction pressure while using the pump, if suction regulator is not contained within the pump kit. 1.18 The personal-use breast pump must contain a mechanism for automatic release of suction at the end of each cycle. 1.19 The personal-use breast pump must maintain a consistent vacuum fluctuation range as the collection container fills with milk, regardless of container size or single/double pumping action. 1.20 The personal-use breast pump motor must: Meet the electrical requirement of a 110-VAC, 60-Hz power input. Comply with all FDA regulations for a Class II Medical Device. Meet the requirements of Underwriters Laboratories Inc.® The UL Mark on the breast pump will be accepted as evidence of compliance. Have a receptacle compatible with the battery pack and vehicle adapter listed in Section 6.0 of this table. (Battery and vehicle adapter may be sold separately). 1.21 Replacement parts must be available on the contract and available for purchase by End-User. These include: Membrane and/or valves. Filters. Tubing. Flanges. Power cords, if detachable.
